[{"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 15741BR\nJob Posting Title Sr Engineer\nCareer Category Operations\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description Serve as a technical expert on a drug product team to support commercialization and trouble shooting of manufacturing process. Activities will pertain to process design, scale-up, characterization and technology transfer of drug product manufacturing operations for validation and registration of protein parenteral products.\n\nThe responsibilities include designing and executing bench and pilot scale experimentation, applying sound scientific theory to experimental work, and optimizing various unit operations including protein freeze/thaw, ultrafiltration/diafiltration, formulation, sterile filtration, mixing, vial and syringe filling and lyophilization. Also conducts experiments, analyzes data, writes technical reports and assessments, and communicates frequently with management and team members. She/he serves as a reliable technical resource for clinical manufacturing support and scale-up of drug product operations for commercial production. The candidate will need to participate in cross-functional teams and work effectively in a highly matrixed team environment.\nBasic Qualifications \u2022 Doctorate degree\nOR\n\u2022 Master\u2019s degree & 3 years of directly related experience\nOR\n\u2022 Bachelor\u2019s degree & 5 years of directly related experience\nOR\n\u2022 Associate\u2019s degree & 10 years of directly related experience\nOR\n\u2022 High school diploma / GED & 12 years of directly related experience\nPreferred Qualifications \u2022 Ph.D. in Chemical Engineering, Biochemical Engineering, Pharmaceutical Sciences, or Life Sciences with a pharmaceutical, vaccine, or biotechnology background with 3 + years experience in biotech/pharmaceutical industry.\n\u2022 Experience with formulation and filling process steps of cryopreservation, lyophilization, vial and syringe filling, sterile filtration, and aseptic processing is preferred.\n\u2022 Experience with statistical analysis, design of experiments, and writing/reviewing technical and manufacturing documents.\n\u2022 Experience with process development for Phase I \u2013 III biologic drug products.\n\u2022 Travel may be required.", "date_new": "2012-05-22 19:47:29", "url": "http://www.amgen.jobs/xml/28868627/job", "country": "United States", "company": "Amgen", "title": "Sr Engineer", "reqid": "15741BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 28868627}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 15637BR\nJob Posting Title Associate Manufacturing\nCareer Category Operations\nEmployee Subgroup Hourly FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description Under general supervision, performs manufacturing unit operations according to Manufacturing Procedures (MPs) and Standard Operating Procedures (SOPs).\n\nSpecific Job Duties:\nThis is a production floor position supporting fermentation and or purification unit operation execution.\n- Use understanding of process theory to perform and monitor critical processes.\n- Perform routine manufacturing operations and operate equipment in the manufacturing area.\n- Execute routine validation protocols.\n- Set-up, clean, and sanitize labware and equipment.\n- Prepare media and/or buffers and other process materials.\n- Recognize & accurately report problems.\n- Generate and own class 1 non-conformances.\n- Participate in resolving problems during operations.\n- Document activities as appropriate (i.e., MPs and logs) using Good Documentation Practices (GDPs).\n- May draft and revise documents (e.g., SOPs).\n- Assist in the review of documentation for assigned functions (e.g. equipment logs, routine area audits, batch records).\n- Comply with and reinforce cGMPs and safety requirements.\nBasic Qualifications \u2022 Bachelor\u2019s degree\nOR\n\u2022 Associate\u2019s degree & 4 years of directly related experience\nOR\n\u2022 High school diploma / GED & 6 years of directly related experience\nPreferred Qualifications - Bachelor\u2019s degree in Science or Engineering and 3 years experience in a biotech/pharma manufacturing environment or /manufacturing support role (i.e. laboratories, engineering, utilities/facilities, quality).\n- Ability to assemble, disassemble, operate, and understand complex equipment per procedures.\n- Ability to perform basic computer operations, such as ability to navigate in MS Office, use email, and complete training using Computer Based Training (CBT).\n- Ability and willingness to work any day, swing, or grave shift in support of operations that may include 24/7.\n- Ability to understand, apply, and evaluate basic chemistry, biology and physical principles as appropriate for the position.\n- Capacity to follow written procedures, recognize and report malfunctions and make adjustments to equipment.\n- Documentation skills.\n- Written and oral communication skills. Proficiency in reading and writing English.\n- Basic problem solving skills.\n- Ability to lift 30 lbs.", "date_new": "2012-05-21 18:12:07", "url": "http://www.amgen.jobs/xml/28833041/job", "country": "United States", "company": "Amgen", "title": "Associate Manufacturing", "reqid": "15637BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 28833041}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 15191BR\nJob Posting Title Principal Engineer - Primary Container Engineering\nCareer Category Operations\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description The successful candidate for this position is required to provide hands-on technical leadership to primary container selection and commercialization as it relates to Design for Manufacturability (DFM) . Job responsibilities will be primarily focused on providing expert technical leadership in ensuring that the design of primary containers, and their packaging systems (for aseptic containers) integrate flawlessly with fill finish equipment. This includes expertise in determining critical interfaces of the container design and equipment.\n\n\u2022 Apply expertise in a fundamental scientific principles to analyze the component design and machinery interfaces both in terms of geometric dimensions and tolerances, forces and kinetics.\n\u2022 Evaluate and solve complex technical issues, design, execute and interpret necessary experiments, lead technology transfers, and address complex process deviations.\n\u2022 Communicate and/or present scientific and technical information within area of expertise to a diverse set of audiences, including project teams, and senior management.\n\u2022 Operate in a highly matrixed environment to collaborate effectively with cross functional teams, critically analyze study protocols, reports and risk assessments, communicate and elevate technical or strategic issues to team members and management as needed, and make recommendations and/or decisions to guide successful execution of process transfers.\n\u2022 Apply fundamental scientific (Mechanical Engineering, Material Sciences, statistics, etc.) to identify and ensure scalable component/equipment systems that can be transferred to high speed production.\nBasic Qualifications \u2022 Doctorate degree & 2 years of directly related experience\nOR\n\u2022 Master\u2019s degree & 6 years of directly related experience\nOR\n\u2022 Bachelor\u2019s degree & 8 years of directly related experience\nOR\n\u2022 Associate\u2019s degree & 10 years of directly related experience\nOR\n\u2022 High school diploma / GED & 12 years of directly related experience\nPreferred Qualifications \u2022 Ph.D. in Mechanical Engineering, or Material Science, or related field with 3 + years experience within a regulated industry; experience to include physical characterization of componnets, and experience in developing manufacturing processes from pilot to production scale with an aim for zero preventable defects. .\n\u2022 Experience including optimization of equipment designs, and equipment interactions, statistical design (Six sigma is highly desired), Geometric Dimensions and Tolerances, Kinetic modeling, DOE, and DFM tool sets.\n\u2022 Strong problem solving, trouble shooting, and communication skills are required.\n\u2022 Ability to participate in global cross-functional teams and work effectively in a highly matrixed team environment.\n\u2022 Participate as author for process documentation of primary containers, technical reports.\n\u2022 The candidate must have experience in scaling production processes in a regulated environment.", "date_new": "2012-05-11 18:17:19", "url": "http://www.amgen.jobs/xml/28633309/job", "country": "United States", "company": "Amgen", "title": "Principal Engineer - Primary Container Engineering", "reqid": "15191BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 28633309}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 15517BR\nJob Posting Title Principal Engineer - Drug Product Engineering\nCareer Category Operations\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description This is a high level position for a subject matter expert within the Drug Product Engineering Organization. They will be responsible for providing scientific and technical leadership and strategic direction to process development of small molecule dosage forms. They will drive development and implementation of key organizational business processes including QbD approach, GMP expectation and process development by interacting with internal, pharmaceutics, quality and regulatory functions. This is a high visibility technical/leadership position within a growing team.\nSpecific responsibilities are described below\n\u2022 Perform process development, characterization and scale-up for late phase drug candidates\n\u2022 Define manufacturing process and its control strategy\n\u2022 Support design, execution and review of process performance qualification runs at commercial manufacturing site\n\u2022 Perform process monitoring, trending and improvement for commercial drug products\n\u2022 Support GMP productions\n\u2022 Draft relevant CMC sections in marketing applications and/or annual updates\n\u2022 Enable project progression by cross-functional collaboration and documentation of study results/findings into reports\n\u2022 Serve as technical expertise and consultation for internal and external manufacturing sites\n\u2022 Develop process analytical technology (PAT) applications\napplications\nBasic Qualifications \u2022 Doctorate degree & 2 years of directly related experience\nOR\n\u2022 Master\u2019s degree & 6 years of directly related experience\nOR\n\u2022 Bachelor\u2019s degree & 8 years of directly related experience\nOR\n\u2022 Associate\u2019s degree & 10 years of directly related experience\nOR\n\u2022 High school diploma / GED & 12 years of directly related experience\nPreferred Qualifications The ideal candidate will have extensive experience in process characterization, scale-up, technology transfer, validation, and CMC preparation of pharmaceutical dosage forms to support product filing and launch. The primary focus is oral dosage forms. Experienced in injectable dosage forms is a big plus.\nSuccess in this role is strongly dependent upon the individual's ability to effectively communicate and collaborate with team members and/or external partners (e.g., CMO). The candidate should have a collaborative mindset and strong leadership/communication skills for sharing insights and best practice and diligently focus on accomplishing scheduled assignments in a timely manner.\nThe talented individual we seek will demonstrate a thorough understanding of dosage form development, regulatory & quality considerations, and possess hands-on experience with processing equipment.\n\nQualifications should include:\n\u2022 Advanced degree in Biochemical Engineering, Biotechnology, or Pharmaceutical Sciences and 8 years relevant work experience in process/formulation development of pharmaceutical dosage forms\n\u2022 Knowledge of the drug development process\n\u2022 Leadership experience of progressively increased scope.\n\u2022 Strong interdisciplinary project management skills.\n\u2022 Ability to independently uncover and resolve issues associated with the development and implementation of scientific projects.\n\u2022 Should have strong communication skills, both written and oral.\n\u2022 Ability to think and operate strategically, as well as formulate, write, present and execute well-designed strategies and plans.\n\u2022 Team leadership, management, and facilitation skills are required.", "date_new": "2012-05-02 18:26:35", "url": "http://www.amgen.jobs/xml/28331570/job", "country": "United States", "company": "Amgen", "title": "Principal Engineer - Drug Product Engineering", "reqid": "15517BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 28331570}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 15391BR\nJob Posting Title Sr Project Mgr - Drug Delivery\nCareer Category Operations\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description The Drug Delivery PMO is a function within Operations\u2019 Drug Delivery organization that provides portfolio and project management leadership to advance device business process programs at Amgen and ensures the device development business and governance processes are followed. As part of the Drug Delivery PMO team, the successful candidate will support the Drug Delivery organization to:\n\u2022 Lead complex, cross functional business process projects for maturing the device business across Amgen and ensuring that it meets regulatory requirements. These projects will involve aligning disciplines such as Quality systems, commercialization, clinical trials, regulatory filings and design transfer. Current areas of focus will include integration of the device business process in Amgen\u2019s Quality systems; ensuring that clinical trials management can effectively handle devices and ensuring that Device Design Control regulatory requirements are met through the device business process and Amgen\u2019s systems.\n\u2022 Utilizing Operational Excellence discipline, drive sustainment and continuous improvements in the overall device business to drive efficiency and effectiveness.\n\u2022 Manage the development of best practices for tools and templates required for a device development projects\n\nResponsibilities\nKey responsibilities include, but are not limited to, the following:\n\u2022 Lead multi-disciplinary device business process projects with a clearly articulated scope using standard project management methodology.\n\u2022 Develop statements of work and manage outside consultants to provide subject matter expertise on projects\n\u2022 Lead functional stakeholders in defining scope, risks and schedule to integrate device requirements into current business process and quality systems.\n\u2022 Support the creation and management of a master device business process maturity strategy\n\u2022 Accountable for defining, leading, and delivering results for projects supporting device network goals\n\u2022 Own deliverables throughout project lifecycle, aligning work from a broad set of project stakeholders\n\u2022 Integrate all key activities and project milestones into the master device business process maturity plan\n\u2022 Represent program in routine leadership briefings and stakeholder communications for aspects of assigned initiatives\nBasic Qualifications \u2022 Doctorate degree & 2 years of directly related experience\nOR\n\u2022 Master\u2019s degree & 6 years of directly related experience\nOR\n\u2022 Bachelor\u2019s degree or & 8 years of directly related experience\nOR\n\u2022 Associate\u2019s degree & 10 years of directly related experience\nOR\n\u2022 High school diploma / GED & 12 years of directly related experience\nPreferred Qualifications Bachelor\u2019sDegree in engineering, life-science or business and 8 years of directly related experience\n\nExperience working on medical devices\n\nKnowledge of Amgen\u2019s current commercialization process\n\n7 or more years in Continuous Improvement, Industrial Engineering, Lean Manufacturing, Six Sigma or related functional experience within Quality, Manufacturing, Development, Research or Process Development\n\nCertified or experience in process improvement methodologies such as Six Sigma/DMAIC/DFSS or PDCA\n\nDemonstrated ability to forge and maintain strong relationships with multiple functional areas\n\nStrong leadership skills\n\nAbility to tactfully and effectively negotiate and influence\n\nAbility to communicate and present ideas to all levels of staff and management\n\nBe a team player and self-starter who is capable of growth and increased responsibility\n\nProficient in basic project management methodology and tools\n\nGood analytical problem solving skills\n\nProficiency in MS office suite including Excel, Power Point, and Project", "date_new": "2012-04-24 20:53:48", "url": "http://www.amgen.jobs/xml/28152837/job", "country": "United States", "company": "Amgen", "title": "Sr Project Mgr - Drug Delivery", "reqid": "15391BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 28152837}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 15356BR\nJob Posting Title Sr Engineer - Drug Process Development\nCareer Category Operations\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description Provide process development technical support to protein drug product manufacturing at Amgen contracted manufacturing sites including process performance; implementation of process improvement strategies; development of process models.\n\n\u2022 Act as a drug product contract manufacturing technical expert and team leader to provide leadership and solutions when troubleshooting drug substance freezing/thawing, formulation, filling vials/syringes/devices, lyophilization, inspection, and transportation, for protein parenteral products.\n\u2022 Provide process development expertise for commercial drug product processing in specific areas such as Sterile processing, Process Characterization, Tech Transfer and Validation. Support commercial drug product manufacturing operations with technical evaluation of NC/CAPA, scale up, validation, and technology transfer.\n\u2022 Troubleshoot issues with drug product processing technologies and equipment.\n\u2022 Develop and characterize drug product processes and transfer technology to commercial drug product sites.\n\u2022 Conduct risk assessment for drug product operations and propose / implement appropriate CAPA.\n\u2022 Identify and implement operational opportunities for current and new sterile operations.\n\u2022 Responsibilities may include leading cross-site teams to support the above activities, providing recommendations to management.\n\u2022 Travel to domestic and international contract manufacturing sites required\nBasic Qualifications \u2022 Doctorate degree\nOR\n\u2022 Master\u2019s degree & 3 years of directly related experience\nOR\n\u2022 Bachelor\u2019s degree & 5 years of directly related experience\nOR\n\u2022 Associate\u2019s degree & 10 years of directly related experience\nOR\n\u2022 High school diploma / GED & 12 years of directly related experience\nPreferred Qualifications \u2022 M.S. in Science or Chemical Engineering and 6 + years of experience in support of Commercial Protein Drug Product (DP) processing in specific areas such as Sterile Processing, Process Characterization, Tech Transfer (to commercial DP sites) or Validation.\n\u2022 Strong skills in applying fundamental engineering and scientific principles to the design and implementation of protein freeze-thawing, filtration, mixing, filling, and/or lyophilization processes. Knowledge of protein biochemistry with regard to chemical and physical stability is strongly desired. Excellent written and verbal communication skills.\n\u2022 Project management skills including the ability to manage multiple projects and evaluate project resource requirements.\n\u2022 Strong knowledge of Quality systems, Drug Product Manufacturing and Validation.\n\u2022 Demonstrated ability in providing leadership to cross-functional teams to advance complex projects to completion.", "date_new": "2012-04-24 20:51:14", "url": "http://www.amgen.jobs/xml/28152785/job", "country": "United States", "company": "Amgen", "title": "Sr Engineer - Drug Process Development", "reqid": "15356BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 28152785}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 15092BR\nJob Posting Title Project Manager - Device Delivery\nCareer Category Operations\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description The Project Manager will report into the Program Management Office within the Drug Delivery Organization. This role will lead cross-functional teams from multiple Amgen sites, and external partners, to develop innovative drug delivery devices that are integrated with biologics to create combination drug/device products.\n\nPosition Responsibilities\n\u2022 Perform project management at a high level of professionalism.\n\u2022 Lead projects that utilize internal and external personnel, contract firms, and partners utilizing structured, systematic methodologies to meet objectives.\n\u2022 Follow Amgen\u2019s governance processes, procedures, specifications, design controls, and applicable compliance standards and guidance documents.\n\u2022 Provide advanced knowledge of schedule management techniques and use of Microsoft Project to create and maintain detailed integrated schedule.\n\u2022 Negotiate and resolve personnel or project conflicts and drive consensus among team members to accomplish project and business goals.\n\u2022 Provide leadership to core team members and provide meaningful feedback to functional leaders regarding team member\u2019s performance and ability to perform assigned tasks.\n\u2022 Foster continuous improvement in the organization\u2019s ability to execute programs and projects, from initiation through launch\n\u2022 Manage program resources to meet business objectives.\nBasic Qualifications \u2022 Doctorate degree\nOR\n\u2022 Master\u2019s degree & 3 years of directly related experience\nOR\n\u2022 Bachelor\u2019s degree & 5 years of directly related experience\nOR\n\u2022 Associate\u2019s degree & 10 years of directly related experience\nOR\n\u2022 High school diploma / GED & 12 years of directly related experience\nPreferred Qualifications \u2022Degree in engineering or related life sciences.\n\u2022 4+ years as a project manager leading cross-functional program teams.\n\u2022 Successful track record of developing commercially viable medical devices/pharmaceutical products from concept through to commercialization.\n\u2022 Deep understanding of and experience with disciplined product development processes (phase/gate product development method).\n\u2022Experience developing products that are manufactured at high volumes using automated and semi-automated manufacturing processes.\n\u2022 Successful experience working with contract development firms and contract manufacturers.\n\u2022 Strong oral and written communications skills; strong interpersonal skills; demonstrated time management and decision making skills required.\n\u2022 Advanced proficiency with Microsoft Project; experienced in creating complex schedules with logical relationships between successor and predecessor tasks.\n\u2022 Experienced in performing critical path analysis.\n\u2022 History as a project manager on FDA-approved 510(k) or PMA-approved medical device that was successfully commercialized.\n\u2022 Experienced with planning and composing documents for FDA submissions.\n\u2022 Experienced in creating and maintaining a Design History File.\n\u2022 Experienced within a CE-marked manufacturer.\n\u2022 Proven ability to manage in a highly fluid, matrix environment.\n\u2022 Experienced with managing programs with annual budgets exceeding $5M.\n\u2022 The ideal candidate will have experience from the medical device industry that includes developing patient use devices.\n\u2022 Certification in Project Management highly desired.", "date_new": "2012-04-14 06:56:35", "url": "http://www.amgen.jobs/xml/27897908/job", "country": "United States", "company": "Amgen", "title": "Project Manager - Device Delivery", "reqid": "15092BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 27897908}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 14554BR\nJob Posting Title Sr Packaging Engineer\nCareer Category Operations\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description This position reports into the Primary Container Engineering group under Drug Product Engineering in Thousand Oaks. This position will be required to apply advanced and diverse engineering principles to execute the proper design, qualification and implementation of Primary Packaging components and the associated systems such as documentation, equipment and processes. Knowledge of primary packaging systems and processes, manufacturing fill/finish equipment and processes, material science and quality system is essential to the position.\n\nThis position is responsible and accountable for the following:\n1) Evaluation, recommendation and selection of primary packaging materials for large and small molecule drug products.\n2) Write test and execute protocols, perform technical evaluations and submitting technical assessment reports to justify the use of selected materials.\n3) Write Technical Specifications and Bill of Materials\n4) Representing Primary Container Engineering in Drug Product and Global Operation Teams\n5) Technology transfer from clinical to commercial or from site to site for both packaging components and equipment processes\n6) Ensures that required line trials and packaging validation is conducted prior to introduction of any new or change in components/processes\n7) Ensures cGMP and regulatory compliance are met\n8) Ensures that change control procedures are followed working with QA and Regulatory to implement changes\n9) Author primary container sections for all global market applications and support filing activities\n10) Participants in Pre-Approval Inspections (PAI) and interact with regulatory bodies (e.g., FDA, EMEA, etc) as needed\n11) Collaborates with cross-functional teams (i.e. Research, QA/QC, Supply Chain, Maintenance, Manufacturing, Regulatory, etc.) in pre-commercial and commercial activities.\n12) Assess, develops, and implements solutions for complex problems relating to packaging or packaging systems.\n13) Oversees project implementation of critical new package platforms.\nBasic Qualifications \u2022 Doctorate degree\nOR\n\u2022 Master\u2019s degree & 3 years of directly related experience\nOR\n\u2022 Bachelor\u2019s degree & 5 years of directly related experience\nOR\n\u2022 Associate\u2019s degree & 10 years of directly related experience\nOR\n\u2022 High school diploma / GED & 12 years of directly related experience\nPreferred Qualifications MS in Engineering or Life Sciences\n5 to 7 of packaging engineering experience with 4+ years within the Pharma/Bio industry\nThe position requires excellent organizational, project management, technical problem solving and communication (written and verbal) skills, the ability to work in multi-functional teams and adapt to rapidly changing environment.", "date_new": "2012-04-11 22:06:59", "url": "http://www.amgen.jobs/xml/27821397/job", "country": "United States", "company": "Amgen", "title": "Sr Packaging Engineer", "reqid": "14554BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 27821397}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 15163BR\nJob Posting Title Exec Dir Process Development - Network Process Engineering\nCareer Category Operations\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description The Process and Product Engineering Group (P&PE) is working as an integrated function to deliver reliable clinical supply and enable and support robust commercial processes globally. We will dramatically reshape traditional process characterization, technology transfer, validation and commercial support of both drug substance and drug product through the use of clinical production data, the deployment of transformational remote monitoring and control capabilities, and a state of the art knowledge management system.\n\nThe Executive Director of the newly created Network Process Engineering (NPE) (formerly Global Process Engineering or GPE) will have P&PE-wide responsibility to oversee the development and deployment of critical performance improving analytics and technologies. These will include Process and Systems Analytics, advanced process modeling technologies, P&PE Knowledge Management, CMC Excellence, and business performance capabilities for P&PE including OE, Business Analytics, and PMO. Responsibilities will also include P&PE Materials Science group.\n\nThe Exec Director NPE will also be responsible for working as part of the P&PE Senior Team and with our stakeholders to refine and achieve our future state.\nBasic Qualifications \u2022 Doctorate degree & 6 years of directly related experience\nOR\n\u2022 Master\u2019s degree & 10 years of directly related experience\nOR\n\u2022 Bachelor\u2019s degree & 12 years of directly related experience\nAND\n\u2022 8 years of managerial experience (directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources in a matrixed environment)\nPreferred Qualifications \u2022 Experience within Amgen Operations of leading a Function or Plant, including supervision of senior staff, with demonstrated track record\n\u2022 15+ years of experience in the biotechnology/pharmaceutical industry including engineering and/or advanced business performance improvement\n\u2022 Advanced degree in Science or Engineering\n\u2022 MBA or financial qualification in addition to Science/Engineering degree\n\u2022 Proficient with pharmaceutical product commercialization and life cycle management; ability to recognize strategic implications of complex product development activities\n\u2022 Expertise in business analyses and its application to applied sciences\n\u2022 Excellent communication abilities; ability to communicate vertically and horizontally through multiple channels, to motivate diverse teams, and enable cross-functional collaboration", "date_new": "2012-04-09 21:20:02", "url": "http://www.amgen.jobs/xml/27759044/job", "country": "United States", "company": "Amgen", "title": "Exec Dir Process Development - Network Process Engineering", "reqid": "15163BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 27759044}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 15113BR\nJob Posting Title Sr Systems Engineer\nCareer Category Operations\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description The Sr Systems Engineer (SE) leads small to mid-sized cross-functional program teams to deliver the technical content, performance, intellectual property and quality deliverables of an NPI program. The SE drives the architecture, vision and design requirements for the product all the time balancing implementation complexity, risks, manufacturability, serviceability and quality. The SE must understand and capture the user needs into system requirements and is responsible for the architectural decomposition and allocation to subsystems. The SE ensures that the quality targets are satisfied and retires technical risks as they arise on the program. The SE maintains close interaction with customers to understand and enhance the ability to deliver customer satisfaction through higher product quality.\n\nEnsuring that the quality targets are satisfied and retires technical risks as they arise on the program. Leading the design team and design control process from requirements development and design planning to design transfer. Leading the design team in the development of verification and validation planning and execution. Developing requirements flow down, architecture/system design and analysis, risk analysis, integration and test, manufacturing, field and customer support including corrective and preventative actions to ensure customer satisfaction. Create and maintain artifacts (models, diagrams, documents) by evaluating needs, clarifying requirements, and analyzing use cases and dependencies to functional specifications to support hardware and software development at system and component level. Driving the architecture, vision and design requirements for the product all the time balancing implementation complexity, risks, manufacturability, serviceability and quality to evaluate and select optimum design alternatives.\n\nAccountability:\n\u2022 Analyze problems involving cross-disciplinary aspects of the product development process, synthesize multiple disciplinary solutions. Develop and exploit structured, efficient approaches to analysis and design to solve complex engineering problems.\n\u2022 Provide direction and support for the optimal design of complex, large scale systems through consideration of the system as a whole, rather than individual components of the system.\n\u2022 Provide various client areas with accurate and consistent requirements information to help them make critical technical decisions based on complete and unambiguous insight into cross-systems functionality.\n\u2022 Ensure compliance/closure of Regulatory and Quality requirements before approving Design Control FDRs and NPI program milestones.\n\u2022 Conduct and review advanced computer simulations to design or test products.\n\u2022 Prepare cost estimates on proposed major design products.\n\u2022 Provide technical presentation support and consultation to marketing.\n\u2022 Represent company unit in customer or field force contacts.\n\u2022 Recommend the addition, expansion or termination of research projects and assure the technical soundness of engineering programs.\n\u2022 Produce innovative technical solutions to customers.\n\u2022 Prepare technical proposals for competitive bids.\n\u2022 Develop potential applications to exploit new business opportunities.\n\u2022 Collect and analyze information on competitor product performance.\n\u2022 Utilize project planning and monitoring methods to ensure timely completion.\n\u2022 Originate and communicate concepts which could lead to new products.\n\u2022 Review and approve completed design work.\n\u2022 Actively contributes to identifying and pursuing new technological opportunities\nBasic Qualifications \u2022 Doctorate degree\nOR\n\u2022 Master\u2019s degree & 3 years of directly related experience\nOR\n\u2022 Bachelor\u2019s degree & 5 years of directly related experience\nOR\n\u2022 Associate\u2019s degree & 10 years of directly related experience\nOR\n\u2022 High school diploma / GED & 12 years of directly related experience\nPreferred Qualifications Masters Degree in Engineering and 5 years progressive experience as an engineer or scientist working with Medical Devices, ideally Class II and Class III\n\n\u2022 Demonstrated experience driving CTQ hierarchical decomposition (flow-down) to subsystems and components.\n\u2022 Demonstrated ability to work with technical leadership team to implement product platform/subsystem multi-generation technology plan for a specific release of a global program/product.\n\u2022 Demonstrated broad exposure to HW/SW/Systems design and technical depth in one or more engineering disciplines (Electrical, Mechanical, Software, etc).\n\u2022 Experience in model-based design and UML and Small scale device assembly experience.\n\u2022 Experience in system design and architecture that ensure product development success and ensuring Accurate Development Cycles between teams.\n\u2022 Leadership ability for System Level Design and Testing (Verification and Validation testing of System Level Performance)\n\u2022 Experience in leading system hazard analysis, risk evaluation, and FMECA (failure mode and effect criticality analysis)\n\u2022 Experience in resolving system engineering issues such as device hardware/firmware or device/programmer system architecture design tradeoffs, tolerance/performance analysis, etc.\n\u2022 Deep knowledge of Quality Management System, Quality Management Policy and applicable laws and regulations as they apply to this job type/position\n\u2022 Familiar with the following standards:\nUS Good Manufacturing Practices \u2013 21CFR820\nQuality Management \u2013 ISO 13485\nRisk Management \u2013 ISO 14971\nEU Medical Device requirements \u2013 Council Directive 93/42/EEC\nMedical Electrical Equipment \u2013 EN 60601\n\u2022 Strong background in documenting requirements and providing traceability documentation for FDA Approval - DOORS, Requisite Pro, or other similar requirements management software.\nexperience highly desired\n\u2022 Practical experience in configuration management and change control process/requirements \u2013 CCB (change control board), CIT (change implementation team) concepts\n\u2022 Experience working with cross department teams to analyze feasibility and ensure that all systems are being built in consideration with one another\n\u2022 Experience in leading continuous improvement activities by driving the implementation of process and product quality improvement initiatives.\n\nDesired Characteristics\n\u2022 Demonstrated applied lean 6 Sigma competency\n\u2022 Demonstrated experience with NPI ISO and regulatory compliance process, design history file and collaterals are in place and current.\n\u2022 Creative problem solver and solution developer when presented with conflicting requirements, business demands and technical risks/issues.\n\u2022 Demonstrated skills in proactively identifying, facilitating and driving closure of a product/program.\n\u2022 Strong interpersonal skills\n\u2022 Demonstrated skills in proactively identifying, facilitating and driving closure of a product/program\n\u2022 INCOSE certification or formal Systems Engineering training/certification", "date_new": "2012-04-06 21:46:17", "url": "http://www.amgen.jobs/xml/27706661/job", "country": "United States", "company": "Amgen", "title": "Sr Systems Engineer", "reqid": "15113BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 27706661}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 15121BR\nJob Posting Title Sr Packaging Engineer\nCareer Category Operations\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description This position reports into the Device & Package Engineering (D&PE) group under Global Drug Product and Device Development in Thousand Oaks, CA. The position falls within 2 different categories in D&PE: Pre-Commercial and Commercial Engineering, supporting global supply, launch delivery, partnerships/acquisitions and devices.\n\nThis position will apply advance and diverse engineering principles to execute the design, qualification and implementation of Primary and Secondary Packaging components and the associated systems such as documentation, equipment and processes. Knowledge of primary and secondary packaging systems and processes, manufacturing fill/finish equipment and processes, material science and quality system is essential to the position. This role requires excellent organizational, project management, technical problem solving and communication (written and verbal) skills, and the ability to work in teams and adapt to rapidly changing environment.\n\nThis position is responsible and accountable for the following:\n- Evaluation, recommendation and selection of primary and secondary packaging materials for both large and small molecules product.\n- Write tests protocols, perform technical evaluations and submitting technical assessment reports to justify the use of selected materials.\n- Write Technical Specifications and Bill of Materials\n- Representing PD&E in Drug Product and Global Operation Teams\n- Technology transfer from clinical to commercial or from site to site for both packaging components and equipment processes\n- Ensures that line trials and packaging validation is conducted prior to introduction of any new or change in components/processes\n- Ensures cGMP and regulatory compliance are met\n- Ensures that change control procedures are followed working with QA and Regulatory to implement changes\n- Participants in Pre-Approval Inspections (PAI) and interact with regulatory bodies (e.g., FDA, EMEA, etc) as needed\n- Collaborates with cross-functional teams (i.e. Research, QA/QC, Supply Chain, Maintenance, Manufacturing, Regulatory, etc.) in pre-commercial and commercial activities.\n- Assess, develops, and implements solutions for complex problems relating to packaging or packaging systems.\n- Oversees project implementation of critical new package platforms.\nBasic Qualifications \u2022 Doctorate degree\nOR\n\u2022 Master\u2019s degree & 3 years of directly related experience\nOR\n\u2022 Bachelor\u2019s degree & 5 years of directly related experience\nOR\n\u2022 Associate\u2019s degree & 10 years of directly related experience\nOR\n\u2022 High school diploma / GED & 12 years of directly related experience\nPreferred Qualifications - MS in Packaging, Engineering or Life Sciences\n- 7 or more years of packaging/engineering experience with 4+ years within the Pharma/Bio industry\nDemonstrated Competencies/Skills:\n- Independent thinker with demonstrated skills working in teams or leading\nproject teams\n- Strong Interpersonal and communication skills", "date_new": "2012-04-05 19:45:29", "url": "http://www.amgen.jobs/xml/27668150/job", "country": "United States", "company": "Amgen", "title": "Sr Packaging Engineer", "reqid": "15121BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 27668150}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 15078BR\nJob Posting Title Principal Packaging Engineer\nCareer Category Operations\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description This position reports into the Primary Container Engineering group under Drug Product Engineering in Thousand Oaks. This position will be required to apply advanced and diverse engineering principles to execute the proper design, qualification and implementation of Primary Packaging components and the associated systems such as documentation, equipment and processes. Knowledge of primary packaging systems and processes, manufacturing fill/finish equipment and processes, material science and quality system is essential to the position.\n\nThis position will be located in Thousand Oaks, California.\n\nThis position will be required to:\n\n1) Qualify fill finish processes with cartridge systems. Including cartridge preparation, filling and sealing in pilot to commercial scale.\n2) Evaluate, recommend and select primary packaging materials for large and small molecule drug products.\n3) Write test and execute protocols, perform technical evaluations and submitting technical assessment reports to justify the use of selected materials.\n4) Write Technical Specifications and Bill of Materials\n5) Perform technology transfer from clinical to commercial or from site to site for both packaging components and equipment processes\n6) Ensure cGMP and regulatory compliance are met\n7) Author primary container sections for all global market applications and support filing activities\n8) Collaborate with cross-functional teams (i.e. Research, QA/QC, Supply Chain, Maintenance, Manufacturing, Regulatory, etc.) in pre-commercial and commercial activities.\nBasic Qualifications \u2022 Doctorate degree & 2 years of directly related experience\nOR\n\u2022 Master\u2019s degree & 6 years of directly related experience\nOR\n\u2022 Bachelor\u2019s degree & 8 years of directly related experience\nOR\n\u2022 Associate\u2019s degree & 10 years of directly related experience\nOR\n\u2022 High school diploma / GED & 12 years of directly related experience\nPreferred Qualifications MS or Ph. D in Materials Science, Chemical Engineering or Mechanical Engineering\n6 to 10 years (or more) of experience with 4+ years within the Pharma/Bio industry\n\nDemonstrated General Competencies/Skills:\n1. Independent thinker with demonstrated skills working in teams or leading project teams\n2. Strong Interpersonal and communication skills\n\nDesired Technical Competencies/Skills (any one or multiple combination thereof):\n1. Demonstrated experience with CAD software for modeling container closure systems. Example: Use of Solid WorksTM drawings to assess mechanical interfaces for device integration as well as support for specifications, standards, methods as well as concept modeling.\n2. Design for manufacturability experience (6 Sigma, FEA, etc)", "date_new": "2012-04-04 03:02:49", "url": "http://www.amgen.jobs/xml/27630458/job", "country": "United States", "company": "Amgen", "title": "Principal Packaging Engineer", "reqid": "15078BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 27630458}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 14574BR\nJob Posting Title Sr Packaging Engineer\nCareer Category Operations\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description This position reports into the Device & Package Engineering (D&PE) group under Global Drug Product and Device Development in Thousand Oaks, CA. The position falls within 2 different categories in D&PE: Pre-Commercial and Commercial Engineering, supporting global supply, launch delivery, partnerships/acquisitions and devices.\n\nThis position will apply advance and diverse engineering principles to execute the design, qualification and implementation of Primary and Secondary Packaging components and the associated systems such as documentation, equipment and processes. Knowledge of primary and secondary packaging systems and processes, manufacturing fill/finish equipment and processes, material science and quality system is essential to the position. This role requires excellent organizational, project management, technical problem solving and communication (written and verbal) skills, and the ability to work in teams and adapt to rapidly changing environment.\n\nThis position is responsible and accountable for the following:\n- Evaluation, recommendation and selection of primary and secondary packaging materials for both large and small molecules product.\n- Write tests protocols, perform technical evaluations and submitting technical assessment reports to justify the use of selected materials.\n- Write Technical Specifications and Bill of Materials\n- Representing PD&E in Drug Product and Global Operation Teams\n- Technology transfer from clinical to commercial or from site to site for both packaging components and equipment processes\n- Ensures that line trials and packaging validation is conducted prior to introduction of any new or change in components/processes\n- Ensures cGMP and regulatory compliance are met\n- Ensures that change control procedures are followed working with QA and Regulatory to implement changes\n- Participants in Pre-Approval Inspections (PAI) and interact with regulatory bodies (e.g., FDA, EMEA, etc) as needed\n- Collaborates with cross-functional teams (i.e. Research, QA/QC, Supply Chain, Maintenance, Manufacturing, Regulatory, etc.) in pre-commercial and commercial activities.\n- Assess, develops, and implements solutions for complex problems relating to packaging or packaging systems.\n- Oversees project implementation of critical new package platforms.\nBasic Qualifications \u2022 Doctorate degree\nOR\n\u2022 Master\u2019s degree & 3 years of directly related experience\nOR\n\u2022 Bachelor\u2019s degree & 5 years of directly related experience\nOR\n\u2022 Associate\u2019s degree & 10 years of directly related experience\nOR\n\u2022 High school diploma / GED & 12 years of directly related experience\nPreferred Qualifications - MS in Packaging, Engineering or Life Sciences\n- 7 or more years of packaging/engineering experience with 4+ years within the Pharma/Bio industry\nDemonstrated Competencies/Skills:\n- Independent thinker with demonstrated skills working in teams or leading\nproject teams\n- Strong Interpersonal and communication skills", "date_new": "2012-04-04 03:02:42", "url": "http://www.amgen.jobs/xml/27630449/job", "country": "United States", "company": "Amgen", "title": "Sr Packaging Engineer", "reqid": "14574BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 27630449}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 14301BR\nJob Posting Title Mgr Manufacturing\nCareer Category Operations\nEmployee Subgroup Hourly FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description The successful candidate will be leading a team of experienced manufacturing associates responsible for downstream purification operations to manufacture clinical GMP drug substance.\nThe manager will champion a safe and compliant production environment through on the floor presence.\nThe manager will be an active participant in continuous improvement programs and will translate them onto the manufacturing floor.\n\n\nResponsibilities include:\n\u2022 Selection, training, oversight, performance evaluations, staff relations and development of staff.\n\u2022 Ensures schedule adherence for tasks including but not limited to manufacturing, qualification, and maintenance activities.\n\u2022 Ensures standard operating procedures are accurate for executing unit operations, batch record review is completed accurately meeting disposition timelines, and non conformances are initiated and closed with right the first time documentation.\n\u2022 Utilizes appropriate systems for job duties (SAP, QMTS, and LIMS etc.).\n\u2022 Interacts with business partners and internal & external audit teams including regulatory agencies as directed.\n\u2022 Identifies and implements process and safety improvements and assists in the introduction of new products in the facility and new technology.\n\u2022 Interacts with business partners to assist with scheduling of maintenance tasks, engineering evaluations, quality control sample submission, and quality investigations.\n\u2022 Ability to communicate production floor and project work at different levels of management.\n\u2022 Ability to elevate to sr. and executive management critical and impactful to the business floor events.\n\u2022 Technically competent to make processing decisions. Ability to troubleshoot and perform initial assessment to events that have the potential to impact product quality.\n\u2022 Flexibility to perform shift work (day, swing, and grave shift) as dictated by business needs.\nBasic Qualifications \u2022 Doctorate degree\nOR\n\u2022 Master\u2019s degree & 3 years of directly related experience\nOR\n\u2022 Bachelor\u2019s degree & 5 years of directly related experience\nOR\n\u2022 Associate\u2019s degree & 10 years of directly related experience\nOR\n\u2022 High school diploma / GED & 12 years of directly related experience\nAND\n\u2022 Previous managerial experience directly managing people and/or experience leading teams, projects, programs or directing the allocation of resources\nPreferred Qualifications \u2022 Bachelor's Degree in Life Sciences or Engineering.\n\u2022 Minimally 5 years of related manufacturing experience.\n\u2022 More than 3 years experience in a production floor lead or manager role.\n\u2022 Mechanical ability/expertise coupled with a solid understanding of downstream processes.\n\u2022 Ability to understand analytical methods in the manufacturing areas.\n\u2022 Demonstrated technical writing ability.\n\u2022 Demonstrated project management and presentation skills.\n\u2022 Demonstrated experience with continuous improvement methodologies.", "date_new": "2012-03-28 21:29:29", "url": "http://www.amgen.jobs/xml/27464087/job", "country": "United States", "company": "Amgen", "title": "Mgr Manufacturing", "reqid": "14301BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 27464087}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 14115BR\nJob Posting Title Principal Scientist - Chemicals, Product and Process Engineering\nCareer Category Operations\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description This position is for a subject matter expert within the Product and Process Engineering Organization responsible for providing scientific and technical leadership and strategic direction to the evaluation of designated raw materials, in this case chemicals and excipients used in biopharmaceutical manufacture, and their potential impact on product quality and process performance.\n\nExtensive knowledge of the manufacturing processes of raw materials, their usage, regulatory/compendial requirements, practices, physical/chemical properties and compatibility with proteins, and risks associated with the raw materials for pharmaceutical and biological products is desirable, along with the ability to assess the impact of changes in materials or manufacturing processes. This individual will be responsible for assessing supplier capabilities, technical competencies and understanding of the needs of biopharmaceutical manufacturers along with other team members. The successful candidate will support or lead cross-functional teams of experienced scientists and engineers through project challenges and mentor them in the selection of the most appropriate materials and technologies. The candidate will actively chart the course and translate business strategies into challenging, actionable objectives and plans, and will apply meaningful metrics for projects, personnel and other resources.\nBasic Qualifications \u2022 Doctorate degree & 2 years of directly related experience\nOR\n\u2022 Master\u2019s degree & 6 years of directly related experience\nOR\n\u2022 Bachelor\u2019s degree & 8 years of directly related experience\nOR\n\u2022 Associate\u2019s degree & 10 years of directly related experience\nOR\n\u2022 High school diploma / GED & 12 years of directly related experience\nPreferred Qualifications \u2022 PhD in chemistry, or MS in chemistry with multiple years in the manufacture of pharmaceutical grade materials\n\u2022 Ten years relevant work experience in pharmaceutical/biopharmaceutical applications\n\u2022 Knowledge of Regulatory Filings and the drug development process\n\u2022  Familiarity with aspects of the use of materials in biopharmaceutical applications, from sourcing, developing collaborative relationships between supplier and user, dealing with change notifications and non-conformance investigations.\n\u2022 Knowledge of state of the art technologies and emerging scientific and regulatory directions for testing and securing quality and minimizing variability.\n\u2022 Ability to independently uncover and resolve issues associated with the development and implementation of scientific projects.\n\u2022 Should be recognized in the scientific community and supplier base through a sustained record of publications and patents.\n\u2022 Should have strong communication skills, both written and oral.\n\u2022 Ability to network and build solid working relationships within and across departments, with diverse and remote staff and with external collaborators from key suppliers.\n\u2022 Ability to think and operate strategically, as well as formulate, write, present and execute well-designed strategies and plans.\n\u2022 Team leadership, management, and facilitation skills are required.\n\u2022 Ability to travel (approx 30%) to other Amgen sites and/or support supplier technical assessments or audits at short notice domestically and overseas.", "date_new": "2012-03-16 02:42:34", "url": "http://www.amgen.jobs/xml/27183556/job", "country": "United States", "company": "Amgen", "title": "Principal Scientist - Chemicals,  Product and Process Engineering", "reqid": "14115BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 27183556}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 10371BR\nJob Posting Title Principal Engineer - Primary Container Manufacturing\nCareer Category Operations\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description Primary Container Manufacturing and Device Mechanical Engineer\nThe successful candidate for this position is required to provide hands-on technical leadership to primary container mechanical design.\n\nJob responsibilities will be primarily focused on;\n1. Leading the characterization of mechanical interfaces / interactions of primary containers with equipment and devices,\n2. Development of test methods for mechanical characteristics,\n3. Produce models and drawings using Solid Works,\n4. Perform basic engineering analysis such as tolerance stack up and FMEAs,\n5. Develop and leverage a basic working knowledge of relevant manufacturing processes to apply Design for Manufacturability\n6. Develop and execute test protocols and publish associated reports\n7. Support the maintenance and creation of Design History Files in accordance with established Company's Product Development Process\n\nThis role will be required to collaborate extensively with external suppliers and Drug Delivery/Device teams\n\nThis position may have supervisory opportunities and responsibilities for technical personnel.\nThis position will report to the leader of the Vendor Process Design and Control group and will be located in Thousand Oaks California.  Some domestic and international travel will be required.\nBasic Qualifications \u2022 Doctorate degree & 2 years of directly related experience\nOR\n\u2022 Master\u2019s degree & 6 years of directly related experience\nOR\n\u2022 Bachelor\u2019s degree & 8 years of directly related experience\nOR\n\u2022 Associate\u2019s degree & 10 years of directly related experience\nOR\n\u2022 High school diploma / GED & 12 years of directly related experience\nPreferred Qualifications \u2022 Ph. D. in Materials Science or Mechanical Engineering with 5 or more years of experience in the Pharmaceutical/Biotechnology industry, Medical Device industry.\n\u2022 Experience to include materials processing, mechanical design, physical characterization of glass and plastic systems, statistical process control (SPC), and design of experiments (DOE).\n\u2022 Strong problem solving, trouble shooting, and communication skills are preferred.\n\u2022 Ability to coach junior engineers, participate in global cross-functional teams, and work effectively in a highly matrix environment.\n\u2022 Familiarity with cGMPs, regulatory filings and compliance issues for sterile injectable products manufactured by aseptic filling processing.\n\u2022 Experience in managing multiple projects simultaneously, strategically prioritizing activities, and leading cross functional teams.", "date_new": "2012-03-14 03:14:34", "url": "http://www.amgen.jobs/xml/27126960/job", "country": "United States", "company": "Amgen", "title": "Principal Engineer - Primary Container Manufacturing", "reqid": "10371BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 27126960}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 14269BR\nJob Posting Title Director, Design Assurance - Drug Delivery\nCareer Category Operations\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description The successful Director of Design Assurance (DA) will lead and build a dynamic team that supports all new product development across the organization. In this high profile assignment you will lead a team of direct reports (Quality Engineers) responsible for design assurance for new and existing technology. This team are responsible for accurate, independent evaluation of Design History File documentation, Design intent and Design Quality. A key driver of success in this role is to translate design requirements into processes that ensure quality attributes in the final design are maintained and are practical for manufacturing.\nThe candidate will work closely with R&D to facilitate the development of innovative technology in a timely manner. Programs are focused on early development through transition to manufacturing with some sustaining work and will include risk management, reliability and failure analysis, and quality planning. Other responsibilities include independently determining appropriate test, verification and validation parameters to ensure components and products meet specifications requirements.\nKey Responsibilities:\n\u2022 Plans, conducts and executes design assurance activities requiring judgment in the independent evaluation, selection and the substantial adaptation of best practice engineering techniques, testing procedures and criteria.\n\u2022 Ensure team works closely with product development engineering and the client team to establish the system design specifications and product requirements.\n\u2022 Ensure team works closely with design, development, quality, regulatory, and the client team to establish and document the master verification plan in conformance with the system design specification and sound testing principles.\n\u2022 Plans, coordinates and executes design verification testing to directly support the master verification plan, including any additional activities such as HALT/HASS and IEC 60601-1-x testing and other standardized test methods.\n\u2022 Participates with the engineering team to establish and review the design FMEA, FMECA and other risk related activities (ISO14971).\n\u2022 Facilitate the achievement of business goals for device reliability, quality, customer satisfaction, cost and safety by identification, development, and accomplishment of key initiatives supporting the business objectives and operational goals for device reliability quality improvements, customer satisfaction, supplier and component initiatives, and safety.\n\u2022 Product reliability design improvements by ongoing research, design and further development of existing products to continuously improve device reliability, quality, and customer satisfaction. Validated product changes with completed documentation that meets or exceeds established guidelines, plus well-documented research/analyses that support decisions and conclusions.\nBasic Qualifications \u2022 Doctorate degree & 4 years of directly related experience\nOR\n\u2022 Master\u2019s degree & 8 years of directly related years\nOR\n\u2022 Bachelor\u2019s degree & 10 years of directly related experience\nAND\n\u2022 4 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources\nPreferred Qualifications \u2022 Advanced degree in an Engineering discipline, or other Engineering/Life Sciences related discipline and 10 years of business experience, leading development organizations in multiple parallel and virtual development environments.\n\u2022 4 years of engineering managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources and have lead the commercial launch of a medical device.\n\u2022 Certified Quality Assurance professional with 3+ years of direct experience in Quality.\n\u2022 CQA, CQM, Six Sigma Black Belt preferred.\n\u2022 ASQ Certified Quality Manager (CQM), Certified Quality Engineer (CQE), or Certified Auditor credentials (e.g., ISO 13485).\n\u2022 Lean and or Six Sigma Certification.\n\u2022 Previous experience in DA engineering and commercialization process with drug delivery devices and combination drug/device products is desired\n\u2022 DA experience in the design and manufacturing scale-up of injectable devices (e.g. auto-injectors, pens, needle-free injectors, syringes) or devices for non-invasive or minimally invasive drug delivery systems (e.g. pulmonary, transdermal).\n\u2022 Minimum of 8+ years experience working in the development of electro-mechanical systems design, verification and validation.\n\u2022 Microcontroller based firmware experience, Real time OS and SW design test, verification and validation experience (unit, static, dynamic and Cyclomatic complexity analysis).\n\u2022 Ability to write software test cases, protocols, and reports.\n\u2022 Experience with circuit design, analysis, troubleshooting, and testing.\n\u2022 Familiar with PCB/PCA assembly and fabrication.\n\u2022 Strong background with requirements management, configurations management, defect tracking, and requirements tracing tools\n\u2022 Advanced problem-solving, risk assessment, statistical analysis, and negotiation skills expected.\n\u2022 Experience with complex, cross-functional development projects.\n\u2022 Experience working with and leading cross-cultural teams.\n\u2022 Proven ability to apply situational leadership concepts across various intra and inter-departmental matters.\n\u2022 Demonstrated time management, decision making, presentation and organization skills.\n\u2022 Ability to converse technically with mechanical, electronic, software, clinical, regulatory, and quality engineering disciplines.", "date_new": "2012-03-14 03:14:28", "url": "http://www.amgen.jobs/xml/27126959/job", "country": "United States", "company": "Amgen", "title": "Director, Design Assurance - Drug Delivery", "reqid": "14269BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 27126959}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 14117BR\nJob Posting Title Principle Scientist - Plastics, Product and Process Engineering\nCareer Category Operations\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description This high level position for a subject matter expert within the Product and Process Engineering Organization is responsible for providing scientific and technical leadership and strategic direction to the evaluation of designated raw materials, in this case plastics used in single use biopharmaceutical applications, and their potential impact on product quality and process performance. REsponsible to assess the impact of changes in materials or manufacturing processes.\n\nThis individual will be responsible for assessing supplier capabilities, technical competences and understanding of the needs of biopharmaceutical manufacturers along with other team members. The successful candidate will support or lead cross-functional teams of experienced scientists and engineers through project challenges and mentor them in the selection of the most appropriate materials and technologies. The candidate will actively chart the course and translate business strategies into challenging, actionable objectives and plans, and will apply meaningful metrics for projects, personnel and other resources.\nBasic Qualifications \u2022 Doctorate degree & 2 years of directly related experience\nOR\n\u2022 Master\u2019s degree & 6 years of directly related experience\nOR\n\u2022 Bachelor\u2019s degree & 8 years of directly related experience\nOR\n\u2022 Associate\u2019s degree & 10 years of directly related experience\nOR\n\u2022 High school diploma / GED & 12 years of directly related experience\nPreferred Qualifications \u2022 PhD in materials science with specialization in polymers, or multiple years in the manufacture of pharmaceutical plastics\n\u2022 Ten years relevant work experience in use of plastics materials in biopharmaceutical applications\n\u2022 Knowledge of license applications and the drug development process\n\u2022 Familiarity with all aspects of the use of plastics in biopharmaceutical applications, current state of the art technologies and emerging scientific directions.\n\u2022 Leadership experience of progressively increased scope.\n\u2022 Strong interdisciplinary project management skills.\n\u2022 Ability to independently uncover and resolve issues associated with the development and implementation of scientific projects.\n\u2022 Should be recognized in the scientific community and supplier base through a sustained record of publications and patents.\n\u2022 Should have strong communication skills, both written and oral. He/she must network and build solid working relationships across departments, with diverse and remote staff and with external collaborators from key suppliers.\n\u2022 Ability to think and operate strategically, as well as formulate, write, present and execute well-designed strategies and plans.\n\u2022 Team leadership, management, and facilitation skills are required.\nShould be willing to travel (approx 30%) to other Amgen sites and/or support supplier technical assessments or audits at short notice domestically and overseas.\n\u2022 Extensive knowledge of the manufacturing processes, usage, regulatory requirements, practices, scientific properties and risks associated with the raw materials for pharmaceutical and biological products.", "date_new": "2012-03-02 18:37:59", "url": "http://www.amgen.jobs/xml/26890893/job", "country": "United States", "company": "Amgen", "title": "Principle Scientist - Plastics,  Product and Process Engineering", "reqid": "14117BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 26890893}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 14072BR\nJob Posting Title Sr Associate Mfg\nCareer Category Operations\nEmployee Subgroup Hourly FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description Under minimal supervision, the Sr. Associate, Mfg, will routinely perform complex to critical processes according to Standard Operating Procedures in the Manufacturing area, specifically the manufacturing of sterile products. Individual will perform a variety of operations involving the support of aseptic filling, with focus in the operation of automated fill equipment inside the aseptic environment. The individual will support and/or be responsible for the execution of manufacturing/quality systems such as non-conformances, process validation, procedures, training, and new product introductions for the aseptic filling process. The individual will need to apply process, operational expertise, compliance knowledge, and analytical and troubleshooting skills to support manufacturing operations. Candidates should have strong computer skills, GMP knowledge, cGMP Documentation skills, and be able to assemble, disassemble, operate and understand equipment per procedures.\n\n\u2022 Initiate, revise, and approve manufacturing procedures. Ensure all procedures reflect current operations. Serve as a document owner.\n\u2022 Evaluate, plan, and implement solutions for process improvement opportunities.\n\u2022 Provide troubleshooting support.\n\u2022 Assist in generation of training materials and may assist in providing training on scientific or technical aspects of the process.\n\u2022 Assist with managing investigation closure within established goal.\n\u2022 Assist with equipment/system Root Cause Analysis investigations and support trend evaluations.\n\u2022 Participate in the New Product Introduction process to assess requirements for documentation, materials, training, and equipment modifications.\n\u2022 Assist manufacturing change owner on Change Control packages impacting the process.\n\u2022 Train operations personnel on new processes or changes to process\n\u2022 Assist with overseeing engineering studies\n\u2022 Prepare, review, approve, and provide technical support for preparation and execution of relevant technical documents, as required.\nBasic Qualifications \u2022 Master\u2019s degree\nOR\n\u2022 Bachelor\u2019s degree & 2 years of directly related experience\nOR\n\u2022 Associate\u2019s degree & 6 years of directly related experience\nOR\n\u2022 High school diploma / GED & 8 years of directly related experience\nPreferred Qualifications \u2022 Bachelor\u2019s degree in Mechanical Engineering with 2 or more years of experience in biopharma.\n\u2022 Demonstrated ability organizing and leading projects\n\u2022 Experience working within biopharma formulation and filling of parenteral products\n\u2022 Clear understanding of cGMPs.\n\u2022 Strong computer skills.\n\u2022 Strong cross functional communication\n\u2022 Light to moderate lifting and carrying of 15-44lbs, reach above and below shoulder height.\n\u2022 Knowledge of aseptic, barrier (RABs), or isolator technology for parenteral filling operations.\n\u2022 Experience working hands on with equipment and processes and to train other technical staff and operators.", "date_new": "2012-03-01 23:11:26", "url": "http://www.amgen.jobs/xml/26874101/job", "country": "United States", "company": "Amgen", "title": "Sr Associate Mfg", "reqid": "14072BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 26874101}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 14067BR\nJob Posting Title Associate Mfg\nCareer Category Operations\nEmployee Subgroup Hourly FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description Under minimal supervision, an Associate, Mfg, will routinely assist in performing complex to critical processes according to Standard Operating Procedures in the Manufacturing area. Individual will be responsible for the manufacturing of sterile products. Individual will perform a variety of operations involving the support of aseptic filling, primarily operation of automated fill equipment inside the aseptic environment. Candidates should understand basic computer skills, have GMP knowledge, good cGMP Documentation skills, and be able to assemble, disassemble, operate and understand equipment per procedures.\n\nWill need to be available to work non-standard shifts, evenings and/or weekends.\n\nMajor duties will include:\n\u2022 Operation of the fill/stoppering equipment to dispense sterile product into glass containers\n\u2022 Environmental monitoring of the aseptic environment during each fill and after each fill\n\u2022 Loading and unloading of sterile products from freeze dryers\n\u2022 Operation of the continuous particulate monitoring system during each fill\n\u2022 Assembling and disassembling of equipment before and after use\n\u2022 Performing operations during fills by following proper procedures\n\u2022 High levels of housekeeping to conform to cGMP standards\n\u2022 Cleaning and sanitizing aseptic filling areas to maintain the quality of the product\n\u2022 Detailed and accurate documentation in batch production records.\n\u2022 Able to determine availability of components and assign accordingly.\n\u2022 May also be required to assist in training of co-workers.\n\u2022 Able to perform in the aseptic filling areas while maintaining the integrity and cleanliness of these areas by utilizing aseptic gowning requirements and techniques.\nBasic Qualifications \u2022 Bachelor\u2019s degree\nOR\n\u2022 Associate\u2019s degree & 4 years of directly related experience\nOR\n\u2022 High school diploma / GED & 6 years of directly related experience\nPreferred Qualifications \u2022 Bachelors Degree in Mechanical Engineering, or Technology.\n\n\u2022 Exposure to aseptic filling, biopharma manufacturing equipment, trouble shooting and moving machinery.\n\u2022 Light to moderate lifting and carrying of 15-44lbs, reach above and below shoulder height. Need color perception/discrimination, far vision correctable with eye glasses.\n\u2022 cGMP manufacturing experience including mechanical ability/expertise.\n\u2022 Demonstrate technical writing capability.\n\u2022 Demonstrate project management skills, presentation skills, and be able to independently collaborate with outside resources.", "date_new": "2012-03-01 23:11:11", "url": "http://www.amgen.jobs/xml/26874098/job", "country": "United States", "company": "Amgen", "title": "Associate Mfg", "reqid": "14067BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 26874098}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 14074BR\nJob Posting Title Dir Engineering - Human Factors and Industrial Design - Drug Delivery\nCareer Category Operations\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description The successful Director of Human Factors and Industrial Design Engineering (HF/ID) will lead human factors and industrial design activities for development of Amgen drug delivery devices/systems taking into consideration all aspects of the user, the intended use, the use environment (eco-system), and the drug therapy being delivered. The Director will collaborate with marketing, engineering, quality, manufacturing and regulatory team members to create innovative and intuitive-to-use products through the application of human-centered design methodologies through Usability assurance, determination of desired user profiles, development of user documentation, and development of training programs.\nThe Director will partner with marketing to lead internal and external team activities that assure brand driven aesthetics are applied consistently across the entire product portfolio.\nThe successful candidate will be responsible for independently leading the planning, execution and reporting of human factors engineering, user interface and industrial design studies across all device programs according to current regulations and guidelines within the medical device and bio-pharmaceutical industries. The Director HF/ID will ensure that expert HF/ID input is provided to device design teams for establishing design requirements, packaging requirements, training requirements and use instructions. The Director HF/ID will ensure that HF/ID expertise is applied to create and complete design validation activities and clinical studies in support of regulatory submissions. Further, the Director HF/ID will ensure that human factors engineering concepts are incorporated early in the development process based on industry best practices. The Director HF/ID will act as a key advocate for these principles across Amgen.\nEnsures\n\u2022 Human-system capabilities and limitations are properly reflected in the system requirements\n\u2022 Human-system performance characteristics and their associated cost, benefits, and risks assist in deciding among alternatives (especially since lifecycle operation and support costs are often largely dependent upon personnel-related costs)\n\u2022 Human-system performance and safety risks are appropriately addressed in program baseline\n\u2022 Determine the human factors cost, benefit, schedule, and performance baselines for each candidate solution\n\u2022 Identify the human factors and human performance measures and thresholds to be achieved (e.g., for the equipment, software, environment, support concepts, and configurations expected for the solution)\n\u2022 Determine the human factors activities to be undertaken during the program, the schedule for conducting them, their relative priority, and the expected costs to be incurred\n\u2022 Calculate or estimate the relative or absolute benefits of the human factors component of each solution in terms of decision criteria (e.g., cost, schedule, human-system performance\n\nThe position requires excellent organizational, technical problem solving and communication skills (written and verbal), the ability to work in teams, the ability to adapt to a rapidly changing environment, and the ability to lead external design consultants.\nBasic Qualifications \u2022 Doctorate degree & 4 years of applied HF/ID engineering experience\nOR\n\u2022 Master\u2019s degree & 8 years of applied HF/ID engineering experience\nOR\n\u2022 Bachelor\u2019s degree & 10 years of applied HF/ID engineering experience\nAND\n\u2022 4 years of engineering managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources\nPreferred Qualifications \u2022 Bachelor's degree in Human Factors, Industrial Design, Cognitive Psychology, or other Engineering/Life Sciences related discipline and 10 years of business experience, leading development organizations in multiple parallel and virtual development environments.\n\u2022 MS in Human Factors, Industrial Design, Cognitive Psychology, or other Engineering/Life Sciences related discipline\n\u2022 Certified Professional Ergonomist (CPE), Certified Human Factors Professional (CHFP), Certified User Experience Professional (CUXP), Associate Ergonomics Professional (AEP), Associate Human Factors Professional (AHFP), Associate User Experience Professional (AUXP) or Certified Ergonomics Associate (CEA).\n\u2022 Minimum of 8+ years experience working in the development of electro-mechanical systems design, verification and validation\n\u2022 Strong background with requirements management, configurations management, defect tracking, and requirements tracing tools\n\u2022 Advanced problem-solving, risk assessment, statistical analysis, and negotiation skills expected\n\u2022 Experience with complex, cross-functional development projects\n\u2022 Experience working with and leading cross-cultural teams\n\u2022 Proven ability to apply situational leadership concepts across various intra and inter-departmental matters\n\u2022 Demonstrated time management, decision making, presentation and organization skills\n\u2022 Previous experience in HF/ID engineering and commercialization process with drug delivery devices and combination drug/device products is desired\n\u2022 HF/ID experience in the design and manufacturing scale-up of injectable devices (e.g. auto-injectors, pens, needle-free injectors, syringes) or devices for non-invasive or minimally invasive drug delivery systems (e.g. pulmonary, transdermal)\n\u2022 Ability to converse technically with mechanical, electronic, software, clinical, regulatory, and quality engineering disciplines\nThe position requires also requires the following:\n\u2022 Proven experience in the HF/ID principles/methods of human-centered design, observational research, ergonomic design, human/machine interface, and data collection/analysis\n\u2022 Proven experience with using sketch models, low and high fidelity prototypes to identify and eliminate potential use errors early in the development process\n\u2022 Experience working directly with customers to gather, synthesize and convert user research into concepts that differentiate products in the market\n\u2022 Experience working directly with customers to develop and evaluate new product features, user interfaces and ergonomic designs, and with ensuring customer satisfaction\n\u2022 Thorough knowledge of relevant human factors regulations, standards and guidance for medical devices and pharmaceutical packaging\n\u2022 Good understanding of the principles of Medical Device and healthcare regulations including FDAs Quality System Regulation (QSR), ISO 13485:2003, 14971, EN 60601, Council Directive 93/42/EEC, etc.\n\u2022 Experience in design of formative and summative human factor studies to address the needs of the requirements setting, design testing, verification and validation stages of medical device development\n\u2022 Experience in writing human factors engineering protocols and reports as support for registration documentation (e.g. Usability engineering reports)\n\u2022 Proven leadership and experience managing multiple projects with high demand schedules\n\u2022 Experience in management of external partners\n\u2022 Experience with establishing departmental or program objectives following company policies and establishing procedures that are measureable with outcomes can be quantified", "date_new": "2012-02-25 18:46:50", "url": "http://www.amgen.jobs/xml/26756596/job", "country": "United States", "company": "Amgen", "title": "Dir Engineering - Human Factors and Industrial Design - Drug Delivery", "reqid": "14074BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 26756596}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 13873BR\nJob Posting Title Manufacturing Specialist - NPI/Packaging\nCareer Category Operations\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description This role will work within the New Product Introduction group of Amgen\u2019s ATO Fill and Packing Organization and will be a key process leader in the introduction of new products within the Packaging department.\n\nThe specialist will be a representative for ATO Packaging within the clinical commercialization program and serve as a key manufacturing operations liaison for new product introductions with an high degree of expected interaction with Quality, Planning, Engineering, Clinical Planning, Process Development, Global Operations teams, and other supportive and client groups.\n\nAdditional responsibilities will include routine interaction with key quality and manufacturing systems, as well as with Operational Excellence (OE) initiatives, and global networks.\n\nAreas of scope and responsibilities include but are not limited to:\n\n\u2022 Supporting/Leading New Product Introductions (NPIs)\n\u2022 Ability to write, revise, and own manufacturing documentation (SOPs, Manufacturing Procedures, Device requirements (MPs), Forms)\n\u2022 Owner/lead author for Non-Conformances (NC\u2019s), Corrective and Preventive Actions (CAPA\u2019s), and Change Controls records that occur in association with the new product introduction process.\n\u2022 Work closely with Regulatory, Quality, and required accessors to manage change control processes and respond to regulatory questions and/or audit findings within the scope of the new product introductions\n\u2022 Operational Excellence (OE) core team member who will champion OE initiatives, and facilitate the drive towards continuous improvement as it relates to new product introductions processes and shared opportunities with client and support groups\n\u2022 Work closely with Quality, Engineering, Process Development, Validation, and Operations to resolve project management issues in a timely manner\n\u2022 Assure appropriate escalation to various levels of management when timeline requirements for new product introduction are at risk or exceeded\n\u2022 Collaborate with Quality, Mfg Managers, Plant Engineering, Process Development and Regulatory Compliance staff in cross-functional teams\n\u2022 Apply advanced process, operational, scientific expertise, compliance knowledge and analytical and troubleshooting skills to support manufacturing operations\n\u2022 Manage generation and presentation of key operating metrics for functional area\n\u2022 Provide training to manufacturing staff in support of new product introduction where appropriate\nBasic Qualifications \u2022 Doctorate degree\nOR\n\u2022 Master\u2019s degree & 3 years of directly related experience\nOR\n\u2022 Bachelor\u2019s degree & 5 years of directly related experience\nOR\n\u2022 Associate\u2019s degree & 10 years of directly related experience\nOR\n\u2022 High school diploma / GED & 12 years of directly related experience\nPreferred Qualifications Bachelor\u2019s degree & 5 years of directly related experience in a biotech/pharma manufacturing or manufacturing support role (ie process development, engineering, quality)\n\u2022 Project management experience\n\u2022 Detailed technical understanding of packaging operations\n\u2022 Experience participating in and leading cross-functional teams\n\u2022 Experience in managing multiple, competing priorities in a fast-paced environment\n\u2022 Strong technical writing and verbal presentation skills\n\u2022 Ability to be flexible and manage change\n\u2022 Ability to effectively communicate complex technical information with internal and external colleagues of varying organizational levels in both presentation and technical writing forms\n\u2022 Ability to communicate/manage upwards to high level stake holders (Director and above)\n\u2022 Highly detailed orientated\n\u2022 Exceptional organizational skill\n\u2022 Experience with a Current Good Manufacturing Practices (cGMP)\n\u2022 Experience with change control and non-conformance management systems/processes\nPreferred Qualifications:\n\u2022 Extensive technical knowledge of drug product packaging, drug product delivery devices, and a broad understanding of related disciplinary areas\n\u2022 Experience interacting with representatives of regulatory agencies\n\u2022 Detailed technical understanding of packaging operations\n\u2022 Strong experience with Microsoft Office suite - PowerPoint, Word, Outlook\n\u2022 Advanced Microsoft Excel experience in the management/analysis of data; including use of Excel Pivot Tables and advanced Excel chart management (formula statements, etc)\n\u2022 Strong experience with Microsoft SharePoint environment including the creation and management of Ninetex workflow\n\u2022 Ability to organize, analyze, and interpret technical data through trend analysis, forecasting, modeling, etc.\n\u2022 Understands the core functional business processes and their role in Amgen's commercialization program", "date_new": "2012-02-16 21:59:19", "url": "http://www.amgen.jobs/xml/26576291/job", "country": "United States", "company": "Amgen", "title": "Manufacturing Specialist - NPI/Packaging", "reqid": "13873BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 26576291}, {"country_short": "USA", "city": "Boulder", "description": "Auto req 13823BR\nJob Posting Title Sr Engineer - Mfg Projects\nCareer Category Operations\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - Colorado\nLocation (City) Boulder\nAmgen Job Description Amgen Colorado\u2019s Engineering team is responsible for delivering capital and expense improvement projects to our client\u2019s business needs. We target small to moderate sized projects located within operating business units. We feature staff with diverse engineering backgrounds with intimate knowledge of operations and working in GMP environments. We minimize impact to client operations due to excellent planning, coordination, and controls.\n\nThe Sr. Engineer is responsible for engineering design, implementation, construction support, technical execution and commissioning for multiple capital and expense projects at Amgen Colorado. This involves preparation of engineering studies, conceptual design alternatives, schematic and design details, and commissioning protocols.\n\n\u2022 Supports the project team during engineering studies geared toward developing the technical and business justification for engineering projects.\n\u2022 Work with clients and stakeholders from manufacturing, process development, facilities, quality assurance and validation to develop and define user requirements.\n\u2022 Responsible for identifying and refining design alternatives during conceptual schematic design evaluations.\n\u2022 Responsible for executing and/or directing, coordinating and supervising the work of consultants and engineering firms during the schematic and detailed design phases.\n\u2022 Executes and/or directs technical resources during the implementation phase (includes construction, startup, commissioning, and validation).\n\u2022 Responsible for turnover packages prepared during the detailed design phase and project close out.\n\u2022 Responsible in ensuring that all Amgen standards and procedures are followed by the project team.\n\u2022 Verifies that all change control procedures are properly documented.\n\u2022 Works closely with other discipline and/or project engineers to coordinate the design and implementation.\n\u2022 May work in as a discipline or project engineer depending on the needs of each project.\nBasic Qualifications \u2022 Doctorate degree\nOR\n\u2022 Master\u2019s degree & 3 years of directly related experience\nOR\n\u2022 Bachelor\u2019s degree & 5 years of directly related experience\nOR\n\u2022 Associate\u2019s degree & 10 years of directly related experience\nOR\n\u2022 High school diploma / GED & 12 years of directly related experience\nPreferred Qualifications Bachelor degree in Engineering and 8+ years of related engineering experience with four of those years engaged in projects in a manufacturing environment.\n\nDemonstrated understanding of project life cycle, versatility, adaptability, decision making skills, collaboration, accountability, problem solving skills, teamwork, and quality control on engineering projects. Position requires excellent technical writing and verbal communication skills.\n\nDemonstrated track record of being science-based, competing intensely and winning, creating value for patients, staff and stockholders, being ethical, trusting and respecting each other, working in teams, ensuring quality, and collaborating, communicating, and being accountable.\n\n? Experience with design and implementation in a manufacturing environment, and with validation and change control methodology strongly desired.\n? Knowledge and skills in Microbial and Mammalian Fermentation, Cell Culture and Purification systems strongly desired.\n? Demonstrated leadership experience\n? Project management experience\n? Technology transfer experience\n? Knowledge of cGMP pharmaceutical manufacturing process design requirements.\n? High level experience with design, programming, and commissioning activities for all automation/process systems and controllers (such as SLC, PLC, DeltaV, BMS, HMI & SCADA).\n?  Ability to review and approve engineering documentation such as requirements and design documents, I/O diagrams, one-line diagrams, panel layout diagrams, system architecture diagrams, and instrument data sheets.", "date_new": "2012-02-10 18:16:30", "url": "http://www.amgen.jobs/xml/26456571/job", "country": "United States", "company": "Amgen", "title": "Sr Engineer - Mfg Projects", "reqid": "13823BR", "state": "Colorado", "state_short": "CO", "location": "Boulder, CO", "uid": 26456571}, {"country_short": "USA", "city": "Seattle", "description": "Auto req 13373BR\nJob Posting Title Scientist - Biotech Engineering\nCareer Category Operations\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - Washington\nLocation (City) Seattle\nAmgen Job Description A Scientist would be expected to act as a lead technical support for a pre-commercial drug product program within process development to achieve the resolution of technical issues, to author technical documents and support all technical issues around commercialization of the drug product. Support of technology transfer and site selection, equipment selection, process design, validation strategy, and relevant GMP documentation is also required.\nThe scientist applies fundamental scientific (biochemistry, biophysics, statistics, etc.) and engineering principles to resolve processing issues and develop a robust commercial product, as well as evaluating changes such as process improvements, equipment, scale, and raw materials Participate as author for process transfer documentation, technical reports, batch records, GMP documentation and\nregulatory filings. Travel will be required.\nBasic Qualifications \u2022 Doctorate degree\nOR\n\u2022 Master\u2019s degree & 3 years of directly related experience\nOR\n\u2022 Bachelor\u2019s degree & 5 years of directly related experience\nOR\n\u2022 Associate\u2019s degree & 10 years of directly related experience\nOR\n\u2022 High school diploma / GED & 12 years of directly related experience\nPreferred Qualifications Ph.D. in Chemical Engineering, Biochemical Engineering, Pharmaceutical Sciences or Life Sciences. 4+ years of relevant biotech experience in process development within a pharmaceutical or biotechnology corporation.\nAbility to apply fundamental scientific (biochemistry, biophysics, statistics, etc.) and engineering principles to develop the drug product process, troubleshoot manufacturing operations, evaluate equipment design, and scale up the drug product process.\nExperience with process development for biologics including lyophilization cycle development.\nExperience participating in global, cross-functional teams working on technology transfer of biologics.", "date_new": "2012-02-08 02:38:38", "url": "http://www.amgen.jobs/xml/26389646/job", "country": "United States", "company": "Amgen", "title": "Scientist - Biotech Engineering", "reqid": "13373BR", "state": "Washington", "state_short": "WA", "location": "Seattle, WA", "uid": 26389646}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 12623BR\nJob Posting Title Sr Engineer - Facilities/Utilities\nCareer Category Operations\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description \u2022 As a member of the Clinical Bulk Facilities & Engineering organization, this position serves as the plant engineer and system owner for facility/utility systems and equipment in a bulk biopharmaceutical manufacturing facility. Responsibilities include providing operational support, troubleshooting, and optimization for assigned equipment; directing and coordinating equipment maintenance to improve reliability; and applying advanced engineering principles to the design and implementation of new equipment.\n\u2022 Support system reliability and operational optimization efforts. Identify system performance risks (e.g. single point of failure or obsolescence) and implement risk reduction strategies. Lead and execute improvement efforts (including identifying cycle reduction time opportunities, efficiency gains, and yield enhancement opportunities).\n\u2022 Lead technical root cause analysis, incident investigations, and troubleshooting on equipment (mechanical, electrical, instrumentation and control system problems). Previous formal training and/or demonstrated experience is preferred.\n\u2022 Analyze problems, develop and propose engineering solutions in a scientific manner using data-driven techniques and analyses (e.g. Statistical Process Control, Six Sigma, predictive maintenance analysis, etc.)\n\u2022 Support new product introductions or new technology introductions by performing engineering assessments, implementing equipment modifications, and supporting engineering runs.\n\u2022 Responsibilities will include support of capital projects. This role involves the application of advanced process engineering principles in the design, specification, construction, startup, and validation of process equipment and systems for capital projects of significant scope and complexity. Demonstrated understanding of project life cycles is preferred. Candidate should be familiar with engineering processes from initial conceptualization through project turnover to operations.\n\u2022 Ensures the logical, systematic translation of design requirements and constraints into process equipment/system solutions. Assists with project definition by performing engineering studies and assessments for process equipment systems, clean utilities, and production facility improvements.\n\u2022 Desired skills include demonstrated ability to translate production processes and user requirements into detailed designs aligned with industry practices; ability to apply knowledge of engineering principles and practices outside of discipline expertise to a broad variety of assignments in related fields; and ability to employ advanced techniques within area of engineering expertise.\n\u2022 Support a safe working environment by complying with all pertinent environmental health/safety practice, rules and regulations.\nBasic Qualifications Doctorate degree\nOR\nMaster\u2019s degree & 3 years of experience directly related to the job\nOR\nBachelor\u2019s degree & 5 years of experience directly related to the job\nOR\nAssociate\u2019s degree & 10 years of experience directly related to the job\nOR\nHigh school diploma / GED & 12 years of experience directly related to the job\nPreferred Qualifications \u2022 Bachelor\u2019s degree in Chemical Engineering or Mechanical preferred\n\u2022 6+ years of relevant work experience with 5+ years experience in operations/manufacturing environment\n\u2022 Direct experience with regulated environments (e.g. cGMP, OSHA, EPA, etc.) is critical. Detailed understanding of industry regulations and ability to interpret in establishing current practices.\n\u2022 Hands-on experience with manufacturing process equipment including advanced troubleshooting, reliability and performance improvements, and design optimization.\n\u2022 Ability to apply advanced engineering principles to the design and implementation of system modifications, introduction of new processes, and execution of capital projects. Develop technical solutions to complex problems requiring the regular use of ingenuity and creativity.\n\u2022 Strong leadership, technical writing, and communication/presentation skills are required.\n\u2022 Work schedule flexibility as required to support 24/7 operations, requiring occasional after-hours engineering coverage.\n\u2022 Direct experience in equipment engineering and troubleshooting with compendial water systems (ie. Water for Injection, Purified Water, and Clean Steam), plant utility systems (eg. clean gases, chilled water, plant steam), and clean room HVAC systems.\n\u2022 Working knowledge and experience with cGMP procedures and engineering practices on pharmaceutical/biotech production processes, facilities, and equipment. Candidate should be experienced in change control, nonconformances, corrective and preventative actions, and validation practices.\n\u2022 Experience in design and startup engineering directly related to bulk biopharmaceutical production including facility design, procurement, construction, startup, and validation is preferred. Equipment acquisition and design engineering experience is desired.\n\u2022 Must be independent, self-motivated, organized, able to multi-task in project environments, and skilled in communication, facilitation, and collaboration. Individual must be a team player prepared to work in and embrace a team-based culture that relies on collaboration for effective decision-making.", "date_new": "2011-11-01 22:17:20", "url": "http://www.amgen.jobs/xml/24526977/job", "country": "United States", "company": "Amgen", "title": "Sr Engineer - Facilities/Utilities", "reqid": "12623BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 24526977}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 12624BR\nJob Posting Title Sr Engineer - Process Equipment\nCareer Category Operations\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description \u2022 As a member of the Clinical Bulk Facilities & Engineering organization, this position serves as a project/plant engineer for facility systems and process equipment in a bulk biopharmaceutical manufacturing facility. Responsibilities include applying advanced engineering principles to the design and implementation of new equipment; providing operational support, troubleshooting, and optimization of assigned manufacturing process equipment; and directing and coordinating equipment maintenance to improve reliability.\n\u2022 This position serves as a lead or discipline engineer for capital projects. This role involves the application of advanced process engineering principles in the design, specification, construction, startup, and validation of process equipment and systems for capital projects of significant scope and complexity. Demonstrated understanding of project life cycles is preferred. Candidate should understand engineering processes from initial conceptualization through project turnover to operations.\n\u2022 Ensures the logical, systematic translation of design requirements and constraints into process equipment/system solutions. Assists with project definition by performing engineering studies and assessments for process equipment systems, clean utilities, and production facility improvements.\n\u2022 Desired skills include demonstrated ability to translate production processes and user requirements into detailed designs aligned with industry practices; ability to apply knowledge of engineering principles and practices outside of discipline expertise to a broad variety of assignments in related fields; and ability to employ advanced techniques within area of engineering expertise.\n\u2022 Support a safe working environment by complying with all pertinent environmental health/safety practice, rules and regulations.\n\u2022 Supports system reliability and operational optimization efforts. Identify system performance risks (e.g. single point of failure or obsolescence) and implement risk reduction strategies. Lead and execute improvement efforts (including identifying cycle reduction time opportunities, efficiency gains, and yield enhancement opportunities).\n\u2022 Lead technical root cause analysis, incident investigations, and troubleshooting on equipment (mechanical, electrical, instrumentation and control system problems). Previous formal training and/or demonstrated experience is preferred.\n\u2022 Analyze problems, develop and propose engineering solutions in a scientific manner using data-driven techniques and analyses (e.g. Statistical Process Control, Six Sigma, predictive maintenance analysis, etc.)\n\u2022 Support new product introductions or new technology introductions by performing engineering assessments, implementing equipment modifications, and supporting engineering runs.\nBasic Qualifications Doctorate degree\nOR\nMaster\u2019s degree & 3 years of experience directly related to the job\nOR\nBachelor\u2019s degree & 5 years of experience directly related to the job\nOR\nAssociate\u2019s degree & 10 years of experience directly related to the job\nOR\nHigh school diploma / GED & 12 years of experience directly related to the job\nPreferred Qualifications \u2022 Master\u2019s degree in Chemical Engineering or Bioengineering preferred\n\u2022 8+ years of relevant work experience with 7+ years experience in operations/manufacturing environment\n\u2022 Direct experience with regulated environments (e.g. cGMP, OSHA, EPA, etc.) is critical. Detailed understanding of industry regulations and ability to interpret in establishing current practices.\n\u2022 Direct experience in equipment engineering and troubleshooting with fermentors, bioreactors, centrifuges, chromatography columns and systems, and/or ultrafiltration/diafiltration systems.\n\u2022 Hands-on experience with manufacturing process equipment including advanced troubleshooting, reliability and performance improvements, and design optimization.\n\u2022 Ability to apply advanced and diverse engineering principles to the design and implementation of major system modifications, introduction of new processes, and capital projects. Develop technical solutions to complex problems requiring the regular use of ingenuity and creativity.\n\u2022 Strong leadership, technical writing, and communication/presentation skills are required.\n\u2022 Work schedule flexibility as required to support 24/7 operations, requiring occasional after-hours engineering coverage.\n\u2022 Working knowledge and experience with cGMP procedures and engineering practices on pharmaceutical/biotech production processes, facilities, and equipment. Candidate should be experienced in change control, nonconformances, corrective and preventative actions, and validation practices.\n\u2022 Experience in design and startup engineering directly related to bulk biopharmaceutical production including process equipment and facilities design, procurement, construction, startup, and validation is preferred. Equipment acquisition and design engineering experience is desired.\n\u2022 Must be independent, self-motivated, organized, able to multi-task in project environments, and skilled in communication, facilitation, and collaboration. Individual must be a team player prepared to work in and embrace a team-based culture that relies on collaboration for effective decision-making.", "date_new": "2011-11-01 22:17:12", "url": "http://www.amgen.jobs/xml/24526976/job", "country": "United States", "company": "Amgen", "title": "Sr Engineer - Process Equipment", "reqid": "12624BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 24526976}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 11568BR\nJob Posting Title Associate Engineer - Drug Delivery Systems\nCareer Category Operations\nEmployee Subgroup Hourly FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description This position reports into the Drug Delivery Systems (DDS) group under Global Drug Product and Device Development in Thousand Oaks. This position will be required to apply advance and diverse engineering principles to execute the proper design, qualification and implementation of devices, diagnostics and ancillary items utilizing associated systems such as documentation, equipment and processes.\nBasic Qualifications \u2022 Bachelor\u2019s degree\nOR\n\u2022 Associate\u2019s degree & 4 years of directly related experience\nOR\n\u2022 High school diploma / GED & 6 years of directly related experience\nPreferred Qualifications BS degree in Mechanical Engineering, or other Engineering/Life Sciences\n3 years of experience in engineering specific to the device or biotech/pharmaceutical industry.\n3 years experience with device design, production and validation\nKnowledge of device development, manufacturing and test equipment, injection molding, and material science is important to the position.\nThe position requires excellent organizational, project management, technical problem solving and communication (written and verbal) skills, and the ability to work in teams and adapt to rapidly changing environment.\nIndependent thinker with demonstrated skills working in teams or leading project teams.", "date_new": "2011-07-29 19:29:32", "url": "http://www.amgen.jobs/xml/22717361/job", "country": "United States", "company": "Amgen", "title": "Associate Engineer - Drug Delivery Systems", "reqid": "11568BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 22717361}]