Amgen Jobshttp://www.amgen.jobs2012-05-26 20:25:04.329372USAThousand OaksAuto req 15741BR Job Posting Title Sr Engineer Career Category Operations Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen 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. The 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. Basic Qualifications • Doctorate degree OR • Master’s degree & 3 years of directly related experience OR • Bachelor’s degree & 5 years of directly related experience OR • Associate’s degree & 10 years of directly related experience OR • High school diploma / GED & 12 years of directly related experience Preferred Qualifications • 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. • Experience with formulation and filling process steps of cryopreservation, lyophilization, vial and syringe filling, sterile filtration, and aseptic processing is preferred. • Experience with statistical analysis, design of experiments, and writing/reviewing technical and manufacturing documents. • Experience with process development for Phase I – III biologic drug products. • Travel may be required.2012-05-22 19:47:29United StatesAmgenCalifornia15741BRCAThousand Oaks, CA28868627http://www.amgen.jobs/xml/28868627/jobUSAThousand OaksAuto req 15637BR Job Posting Title Associate Manufacturing Career Category Operations Employee Subgroup Hourly FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description Under general supervision, performs manufacturing unit operations according to Manufacturing Procedures (MPs) and Standard Operating Procedures (SOPs). Specific Job Duties: This is a production floor position supporting fermentation and or purification unit operation execution. - Use understanding of process theory to perform and monitor critical processes. - Perform routine manufacturing operations and operate equipment in the manufacturing area. - Execute routine validation protocols. - Set-up, clean, and sanitize labware and equipment. - Prepare media and/or buffers and other process materials. - Recognize & accurately report problems. - Generate and own class 1 non-conformances. - Participate in resolving problems during operations. - Document activities as appropriate (i.e., MPs and logs) using Good Documentation Practices (GDPs). - May draft and revise documents (e.g., SOPs). - Assist in the review of documentation for assigned functions (e.g. equipment logs, routine area audits, batch records). - Comply with and reinforce cGMPs and safety requirements. Basic Qualifications • Bachelor’s degree OR • Associate’s degree & 4 years of directly related experience OR • High school diploma / GED & 6 years of directly related experience Preferred Qualifications - Bachelor’s 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). - Ability to assemble, disassemble, operate, and understand complex equipment per procedures. - Ability to perform basic computer operations, such as ability to navigate in MS Office, use email, and complete training using Computer Based Training (CBT). - Ability and willingness to work any day, swing, or grave shift in support of operations that may include 24/7. - Ability to understand, apply, and evaluate basic chemistry, biology and physical principles as appropriate for the position. - Capacity to follow written procedures, recognize and report malfunctions and make adjustments to equipment. - Documentation skills. - Written and oral communication skills. Proficiency in reading and writing English. - Basic problem solving skills. - Ability to lift 30 lbs.2012-05-21 18:12:07United StatesAmgenCalifornia15637BRCAThousand Oaks, CA28833041http://www.amgen.jobs/xml/28833041/jobUSAThousand OaksAuto req 15191BR Job Posting Title Principal Engineer - Primary Container Engineering Career Category Operations Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen 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. • 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. • Evaluate and solve complex technical issues, design, execute and interpret necessary experiments, lead technology transfers, and address complex process deviations. • Communicate and/or present scientific and technical information within area of expertise to a diverse set of audiences, including project teams, and senior management. • 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. • 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. Basic Qualifications • Doctorate degree & 2 years of directly related experience OR • Master’s degree & 6 years of directly related experience OR • Bachelor’s degree & 8 years of directly related experience OR • Associate’s degree & 10 years of directly related experience OR • High school diploma / GED & 12 years of directly related experience Preferred Qualifications • 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. . • 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. • Strong problem solving, trouble shooting, and communication skills are required. • Ability to participate in global cross-functional teams and work effectively in a highly matrixed team environment. • Participate as author for process documentation of primary containers, technical reports. • The candidate must have experience in scaling production processes in a regulated environment.2012-05-11 18:17:19United StatesAmgenCalifornia15191BRCAThousand Oaks, CA28633309http://www.amgen.jobs/xml/28633309/jobUSAThousand OaksAuto req 15517BR Job Posting Title Principal Engineer - Drug Product Engineering Career Category Operations Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen 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. Specific responsibilities are described below • Perform process development, characterization and scale-up for late phase drug candidates • Define manufacturing process and its control strategy • Support design, execution and review of process performance qualification runs at commercial manufacturing site • Perform process monitoring, trending and improvement for commercial drug products • Support GMP productions • Draft relevant CMC sections in marketing applications and/or annual updates • Enable project progression by cross-functional collaboration and documentation of study results/findings into reports • Serve as technical expertise and consultation for internal and external manufacturing sites • Develop process analytical technology (PAT) applications applications Basic Qualifications • Doctorate degree & 2 years of directly related experience OR • Master’s degree & 6 years of directly related experience OR • Bachelor’s degree & 8 years of directly related experience OR • Associate’s degree & 10 years of directly related experience OR • High school diploma / GED & 12 years of directly related experience Preferred 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. Success 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. The talented individual we seek will demonstrate a thorough understanding of dosage form development, regulatory & quality considerations, and possess hands-on experience with processing equipment. Qualifications should include: • Advanced degree in Biochemical Engineering, Biotechnology, or Pharmaceutical Sciences and 8 years relevant work experience in process/formulation development of pharmaceutical dosage forms • Knowledge of the drug development process • Leadership experience of progressively increased scope. • Strong interdisciplinary project management skills. • Ability to independently uncover and resolve issues associated with the development and implementation of scientific projects. • Should have strong communication skills, both written and oral. • Ability to think and operate strategically, as well as formulate, write, present and execute well-designed strategies and plans. • Team leadership, management, and facilitation skills are required.2012-05-02 18:26:35United StatesAmgenCalifornia15517BRCAThousand Oaks, CA28331570http://www.amgen.jobs/xml/28331570/jobUSAThousand OaksAuto req 15391BR Job Posting Title Sr Project Mgr - Drug Delivery Career Category Operations Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description The Drug Delivery PMO is a function within Operations’ 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: • 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’s 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’s systems. • Utilizing Operational Excellence discipline, drive sustainment and continuous improvements in the overall device business to drive efficiency and effectiveness. • Manage the development of best practices for tools and templates required for a device development projects Responsibilities Key responsibilities include, but are not limited to, the following: • Lead multi-disciplinary device business process projects with a clearly articulated scope using standard project management methodology. • Develop statements of work and manage outside consultants to provide subject matter expertise on projects • Lead functional stakeholders in defining scope, risks and schedule to integrate device requirements into current business process and quality systems. • Support the creation and management of a master device business process maturity strategy • Accountable for defining, leading, and delivering results for projects supporting device network goals • Own deliverables throughout project lifecycle, aligning work from a broad set of project stakeholders • Integrate all key activities and project milestones into the master device business process maturity plan • Represent program in routine leadership briefings and stakeholder communications for aspects of assigned initiatives Basic Qualifications • Doctorate degree & 2 years of directly related experience OR • Master’s degree & 6 years of directly related experience OR • Bachelor’s degree or & 8 years of directly related experience OR • Associate’s degree & 10 years of directly related experience OR • High school diploma / GED & 12 years of directly related experience Preferred Qualifications Bachelor’sDegree in engineering, life-science or business and 8 years of directly related experience Experience working on medical devices Knowledge of Amgen’s current commercialization process 7 or more years in Continuous Improvement, Industrial Engineering, Lean Manufacturing, Six Sigma or related functional experience within Quality, Manufacturing, Development, Research or Process Development Certified or experience in process improvement methodologies such as Six Sigma/DMAIC/DFSS or PDCA Demonstrated ability to forge and maintain strong relationships with multiple functional areas Strong leadership skills Ability to tactfully and effectively negotiate and influence Ability to communicate and present ideas to all levels of staff and management Be a team player and self-starter who is capable of growth and increased responsibility Proficient in basic project management methodology and tools Good analytical problem solving skills Proficiency in MS office suite including Excel, Power Point, and Project2012-04-24 20:53:48United StatesAmgenCalifornia15391BRCAThousand Oaks, CA28152837http://www.amgen.jobs/xml/28152837/jobUSAThousand OaksAuto req 15356BR Job Posting Title Sr Engineer - Drug Process Development Career Category Operations Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen 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. • 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. • 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. • Troubleshoot issues with drug product processing technologies and equipment. • Develop and characterize drug product processes and transfer technology to commercial drug product sites. • Conduct risk assessment for drug product operations and propose / implement appropriate CAPA. • Identify and implement operational opportunities for current and new sterile operations. • Responsibilities may include leading cross-site teams to support the above activities, providing recommendations to management. • Travel to domestic and international contract manufacturing sites required Basic Qualifications • Doctorate degree OR • Master’s degree & 3 years of directly related experience OR • Bachelor’s degree & 5 years of directly related experience OR • Associate’s degree & 10 years of directly related experience OR • High school diploma / GED & 12 years of directly related experience Preferred Qualifications • 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. • 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. • Project management skills including the ability to manage multiple projects and evaluate project resource requirements. • Strong knowledge of Quality systems, Drug Product Manufacturing and Validation. • Demonstrated ability in providing leadership to cross-functional teams to advance complex projects to completion.2012-04-24 20:51:14United StatesAmgenCalifornia15356BRCAThousand Oaks, CA28152785http://www.amgen.jobs/xml/28152785/jobUSAThousand OaksAuto req 15092BR Job Posting Title Project Manager - Device Delivery Career Category Operations Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen 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. Position Responsibilities • Perform project management at a high level of professionalism. • Lead projects that utilize internal and external personnel, contract firms, and partners utilizing structured, systematic methodologies to meet objectives. • Follow Amgen’s governance processes, procedures, specifications, design controls, and applicable compliance standards and guidance documents. • Provide advanced knowledge of schedule management techniques and use of Microsoft Project to create and maintain detailed integrated schedule. • Negotiate and resolve personnel or project conflicts and drive consensus among team members to accomplish project and business goals. • Provide leadership to core team members and provide meaningful feedback to functional leaders regarding team member’s performance and ability to perform assigned tasks. • Foster continuous improvement in the organization’s ability to execute programs and projects, from initiation through launch • Manage program resources to meet business objectives. Basic Qualifications • Doctorate degree OR • Master’s degree & 3 years of directly related experience OR • Bachelor’s degree & 5 years of directly related experience OR • Associate’s degree & 10 years of directly related experience OR • High school diploma / GED & 12 years of directly related experience Preferred Qualifications •Degree in engineering or related life sciences. • 4+ years as a project manager leading cross-functional program teams. • Successful track record of developing commercially viable medical devices/pharmaceutical products from concept through to commercialization. • Deep understanding of and experience with disciplined product development processes (phase/gate product development method). •Experience developing products that are manufactured at high volumes using automated and semi-automated manufacturing processes. • Successful experience working with contract development firms and contract manufacturers. • Strong oral and written communications skills; strong interpersonal skills; demonstrated time management and decision making skills required. • Advanced proficiency with Microsoft Project; experienced in creating complex schedules with logical relationships between successor and predecessor tasks. • Experienced in performing critical path analysis. • History as a project manager on FDA-approved 510(k) or PMA-approved medical device that was successfully commercialized. • Experienced with planning and composing documents for FDA submissions. • Experienced in creating and maintaining a Design History File. • Experienced within a CE-marked manufacturer. • Proven ability to manage in a highly fluid, matrix environment. • Experienced with managing programs with annual budgets exceeding $5M. • The ideal candidate will have experience from the medical device industry that includes developing patient use devices. • Certification in Project Management highly desired.2012-04-14 06:56:35United StatesAmgenCalifornia15092BRCAThousand Oaks, CA27897908http://www.amgen.jobs/xml/27897908/jobUSAThousand OaksAuto req 14554BR Job Posting Title Sr Packaging Engineer Career Category Operations Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen 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. This position is responsible and accountable for the following: 1) Evaluation, recommendation and selection of primary packaging materials for large and small molecule drug products. 2) Write test and execute protocols, perform technical evaluations and submitting technical assessment reports to justify the use of selected materials. 3) Write Technical Specifications and Bill of Materials 4) Representing Primary Container Engineering in Drug Product and Global Operation Teams 5) Technology transfer from clinical to commercial or from site to site for both packaging components and equipment processes 6) Ensures that required line trials and packaging validation is conducted prior to introduction of any new or change in components/processes 7) Ensures cGMP and regulatory compliance are met 8) Ensures that change control procedures are followed working with QA and Regulatory to implement changes 9) Author primary container sections for all global market applications and support filing activities 10) Participants in Pre-Approval Inspections (PAI) and interact with regulatory bodies (e.g., FDA, EMEA, etc) as needed 11) Collaborates with cross-functional teams (i.e. Research, QA/QC, Supply Chain, Maintenance, Manufacturing, Regulatory, etc.) in pre-commercial and commercial activities. 12) Assess, develops, and implements solutions for complex problems relating to packaging or packaging systems. 13) Oversees project implementation of critical new package platforms. Basic Qualifications • Doctorate degree OR • Master’s degree & 3 years of directly related experience OR • Bachelor’s degree & 5 years of directly related experience OR • Associate’s degree & 10 years of directly related experience OR • High school diploma / GED & 12 years of directly related experience Preferred Qualifications MS in Engineering or Life Sciences 5 to 7 of packaging engineering experience with 4+ years within the Pharma/Bio industry The 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.2012-04-11 22:06:59United StatesAmgenCalifornia14554BRCAThousand Oaks, CA27821397http://www.amgen.jobs/xml/27821397/jobUSAThousand OaksAuto req 15163BR Job Posting Title Exec Dir Process Development - Network Process Engineering Career Category Operations Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen 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. The 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. The 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. Basic Qualifications • Doctorate degree & 6 years of directly related experience OR • Master’s degree & 10 years of directly related experience OR • Bachelor’s degree & 12 years of directly related experience AND • 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) Preferred Qualifications • Experience within Amgen Operations of leading a Function or Plant, including supervision of senior staff, with demonstrated track record • 15+ years of experience in the biotechnology/pharmaceutical industry including engineering and/or advanced business performance improvement • Advanced degree in Science or Engineering • MBA or financial qualification in addition to Science/Engineering degree • Proficient with pharmaceutical product commercialization and life cycle management; ability to recognize strategic implications of complex product development activities • Expertise in business analyses and its application to applied sciences • Excellent communication abilities; ability to communicate vertically and horizontally through multiple channels, to motivate diverse teams, and enable cross-functional collaboration2012-04-09 21:20:02United StatesAmgenCalifornia15163BRCAThousand Oaks, CA27759044http://www.amgen.jobs/xml/27759044/jobUSAThousand OaksAuto req 15113BR Job Posting Title Sr Systems Engineer Career Category Operations Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen 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. Ensuring 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. Accountability: • 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. • 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. • 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. • Ensure compliance/closure of Regulatory and Quality requirements before approving Design Control FDRs and NPI program milestones. • Conduct and review advanced computer simulations to design or test products. • Prepare cost estimates on proposed major design products. • Provide technical presentation support and consultation to marketing. • Represent company unit in customer or field force contacts. • Recommend the addition, expansion or termination of research projects and assure the technical soundness of engineering programs. • Produce innovative technical solutions to customers. • Prepare technical proposals for competitive bids. • Develop potential applications to exploit new business opportunities. • Collect and analyze information on competitor product performance. • Utilize project planning and monitoring methods to ensure timely completion. • Originate and communicate concepts which could lead to new products. • Review and approve completed design work. • Actively contributes to identifying and pursuing new technological opportunities Basic Qualifications • Doctorate degree OR • Master’s degree & 3 years of directly related experience OR • Bachelor’s degree & 5 years of directly related experience OR • Associate’s degree & 10 years of directly related experience OR • High school diploma / GED & 12 years of directly related experience Preferred 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 • Demonstrated experience driving CTQ hierarchical decomposition (flow-down) to subsystems and components. • 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. • Demonstrated broad exposure to HW/SW/Systems design and technical depth in one or more engineering disciplines (Electrical, Mechanical, Software, etc). • Experience in model-based design and UML and Small scale device assembly experience. • Experience in system design and architecture that ensure product development success and ensuring Accurate Development Cycles between teams. • Leadership ability for System Level Design and Testing (Verification and Validation testing of System Level Performance) • Experience in leading system hazard analysis, risk evaluation, and FMECA (failure mode and effect criticality analysis) • Experience in resolving system engineering issues such as device hardware/firmware or device/programmer system architecture design tradeoffs, tolerance/performance analysis, etc. • Deep knowledge of Quality Management System, Quality Management Policy and applicable laws and regulations as they apply to this job type/position • Familiar with the following standards: US Good Manufacturing Practices – 21CFR820 Quality Management – ISO 13485 Risk Management – ISO 14971 EU Medical Device requirements – Council Directive 93/42/EEC Medical Electrical Equipment – EN 60601 • Strong background in documenting requirements and providing traceability documentation for FDA Approval - DOORS, Requisite Pro, or other similar requirements management software. experience highly desired • Practical experience in configuration management and change control process/requirements – CCB (change control board), CIT (change implementation team) concepts • Experience working with cross department teams to analyze feasibility and ensure that all systems are being built in consideration with one another • Experience in leading continuous improvement activities by driving the implementation of process and product quality improvement initiatives. Desired Characteristics • Demonstrated applied lean 6 Sigma competency • Demonstrated experience with NPI ISO and regulatory compliance process, design history file and collaterals are in place and current. • Creative problem solver and solution developer when presented with conflicting requirements, business demands and technical risks/issues. • Demonstrated skills in proactively identifying, facilitating and driving closure of a product/program. • Strong interpersonal skills • Demonstrated skills in proactively identifying, facilitating and driving closure of a product/program • INCOSE certification or formal Systems Engineering training/certification2012-04-06 21:46:17United StatesAmgenCalifornia15113BRCAThousand Oaks, CA27706661http://www.amgen.jobs/xml/27706661/jobUSAThousand OaksAuto req 15121BR Job Posting Title Sr Packaging Engineer Career Category Operations Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen 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. This 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. This position is responsible and accountable for the following: - Evaluation, recommendation and selection of primary and secondary packaging materials for both large and small molecules product. - Write tests protocols, perform technical evaluations and submitting technical assessment reports to justify the use of selected materials. - Write Technical Specifications and Bill of Materials - Representing PD&E in Drug Product and Global Operation Teams - Technology transfer from clinical to commercial or from site to site for both packaging components and equipment processes - Ensures that line trials and packaging validation is conducted prior to introduction of any new or change in components/processes - Ensures cGMP and regulatory compliance are met - Ensures that change control procedures are followed working with QA and Regulatory to implement changes - Participants in Pre-Approval Inspections (PAI) and interact with regulatory bodies (e.g., FDA, EMEA, etc) as needed - Collaborates with cross-functional teams (i.e. Research, QA/QC, Supply Chain, Maintenance, Manufacturing, Regulatory, etc.) in pre-commercial and commercial activities. - Assess, develops, and implements solutions for complex problems relating to packaging or packaging systems. - Oversees project implementation of critical new package platforms. Basic Qualifications • Doctorate degree OR • Master’s degree & 3 years of directly related experience OR • Bachelor’s degree & 5 years of directly related experience OR • Associate’s degree & 10 years of directly related experience OR • High school diploma / GED & 12 years of directly related experience Preferred Qualifications - MS in Packaging, Engineering or Life Sciences - 7 or more years of packaging/engineering experience with 4+ years within the Pharma/Bio industry Demonstrated Competencies/Skills: - Independent thinker with demonstrated skills working in teams or leading project teams - Strong Interpersonal and communication skills2012-04-05 19:45:29United StatesAmgenCalifornia15121BRCAThousand Oaks, CA27668150http://www.amgen.jobs/xml/27668150/jobUSAThousand OaksAuto req 15078BR Job Posting Title Principal Packaging Engineer Career Category Operations Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen 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. This position will be located in Thousand Oaks, California. This position will be required to: 1) Qualify fill finish processes with cartridge systems. Including cartridge preparation, filling and sealing in pilot to commercial scale. 2) Evaluate, recommend and select primary packaging materials for large and small molecule drug products. 3) Write test and execute protocols, perform technical evaluations and submitting technical assessment reports to justify the use of selected materials. 4) Write Technical Specifications and Bill of Materials 5) Perform technology transfer from clinical to commercial or from site to site for both packaging components and equipment processes 6) Ensure cGMP and regulatory compliance are met 7) Author primary container sections for all global market applications and support filing activities 8) Collaborate with cross-functional teams (i.e. Research, QA/QC, Supply Chain, Maintenance, Manufacturing, Regulatory, etc.) in pre-commercial and commercial activities. Basic Qualifications • Doctorate degree & 2 years of directly related experience OR • Master’s degree & 6 years of directly related experience OR • Bachelor’s degree & 8 years of directly related experience OR • Associate’s degree & 10 years of directly related experience OR • High school diploma / GED & 12 years of directly related experience Preferred Qualifications MS or Ph. D in Materials Science, Chemical Engineering or Mechanical Engineering 6 to 10 years (or more) of experience with 4+ years within the Pharma/Bio industry Demonstrated General Competencies/Skills: 1. Independent thinker with demonstrated skills working in teams or leading project teams 2. Strong Interpersonal and communication skills Desired Technical Competencies/Skills (any one or multiple combination thereof): 1. 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. 2. Design for manufacturability experience (6 Sigma, FEA, etc)2012-04-04 03:02:49United StatesAmgenCalifornia15078BRCAThousand Oaks, CA27630458http://www.amgen.jobs/xml/27630458/jobUSAThousand OaksAuto req 14574BR Job Posting Title Sr Packaging Engineer Career Category Operations Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen 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. This 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. This position is responsible and accountable for the following: - Evaluation, recommendation and selection of primary and secondary packaging materials for both large and small molecules product. - Write tests protocols, perform technical evaluations and submitting technical assessment reports to justify the use of selected materials. - Write Technical Specifications and Bill of Materials - Representing PD&E in Drug Product and Global Operation Teams - Technology transfer from clinical to commercial or from site to site for both packaging components and equipment processes - Ensures that line trials and packaging validation is conducted prior to introduction of any new or change in components/processes - Ensures cGMP and regulatory compliance are met - Ensures that change control procedures are followed working with QA and Regulatory to implement changes - Participants in Pre-Approval Inspections (PAI) and interact with regulatory bodies (e.g., FDA, EMEA, etc) as needed - Collaborates with cross-functional teams (i.e. Research, QA/QC, Supply Chain, Maintenance, Manufacturing, Regulatory, etc.) in pre-commercial and commercial activities. - Assess, develops, and implements solutions for complex problems relating to packaging or packaging systems. - Oversees project implementation of critical new package platforms. Basic Qualifications • Doctorate degree OR • Master’s degree & 3 years of directly related experience OR • Bachelor’s degree & 5 years of directly related experience OR • Associate’s degree & 10 years of directly related experience OR • High school diploma / GED & 12 years of directly related experience Preferred Qualifications - MS in Packaging, Engineering or Life Sciences - 7 or more years of packaging/engineering experience with 4+ years within the Pharma/Bio industry Demonstrated Competencies/Skills: - Independent thinker with demonstrated skills working in teams or leading project teams - Strong Interpersonal and communication skills2012-04-04 03:02:42United StatesAmgenCalifornia14574BRCAThousand Oaks, CA27630449http://www.amgen.jobs/xml/27630449/jobUSAThousand OaksAuto req 14301BR Job Posting Title Mgr Manufacturing Career Category Operations Employee Subgroup Hourly FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen 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. The manager will champion a safe and compliant production environment through on the floor presence. The manager will be an active participant in continuous improvement programs and will translate them onto the manufacturing floor. Responsibilities include: • Selection, training, oversight, performance evaluations, staff relations and development of staff. • Ensures schedule adherence for tasks including but not limited to manufacturing, qualification, and maintenance activities. • 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. • Utilizes appropriate systems for job duties (SAP, QMTS, and LIMS etc.). • Interacts with business partners and internal & external audit teams including regulatory agencies as directed. • Identifies and implements process and safety improvements and assists in the introduction of new products in the facility and new technology. • Interacts with business partners to assist with scheduling of maintenance tasks, engineering evaluations, quality control sample submission, and quality investigations. • Ability to communicate production floor and project work at different levels of management. • Ability to elevate to sr. and executive management critical and impactful to the business floor events. • Technically competent to make processing decisions. Ability to troubleshoot and perform initial assessment to events that have the potential to impact product quality. • Flexibility to perform shift work (day, swing, and grave shift) as dictated by business needs. Basic Qualifications • Doctorate degree OR • Master’s degree & 3 years of directly related experience OR • Bachelor’s degree & 5 years of directly related experience OR • Associate’s degree & 10 years of directly related experience OR • High school diploma / GED & 12 years of directly related experience AND • Previous managerial experience directly managing people and/or experience leading teams, projects, programs or directing the allocation of resources Preferred Qualifications • Bachelor's Degree in Life Sciences or Engineering. • Minimally 5 years of related manufacturing experience. • More than 3 years experience in a production floor lead or manager role. • Mechanical ability/expertise coupled with a solid understanding of downstream processes. • Ability to understand analytical methods in the manufacturing areas. • Demonstrated technical writing ability. • Demonstrated project management and presentation skills. • Demonstrated experience with continuous improvement methodologies.2012-03-28 21:29:29United StatesAmgenCalifornia14301BRCAThousand Oaks, CA27464087http://www.amgen.jobs/xml/27464087/jobUSAThousand OaksAuto req 14115BR Job Posting Title Principal Scientist - Chemicals, Product and Process Engineering Career Category Operations Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen 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. Extensive 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. Basic Qualifications • Doctorate degree & 2 years of directly related experience OR • Master’s degree & 6 years of directly related experience OR • Bachelor’s degree & 8 years of directly related experience OR • Associate’s degree & 10 years of directly related experience OR • High school diploma / GED & 12 years of directly related experience Preferred Qualifications • PhD in chemistry, or MS in chemistry with multiple years in the manufacture of pharmaceutical grade materials • Ten years relevant work experience in pharmaceutical/biopharmaceutical applications • Knowledge of Regulatory Filings and the drug development process • 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. • Knowledge of state of the art technologies and emerging scientific and regulatory directions for testing and securing quality and minimizing variability. • Ability to independently uncover and resolve issues associated with the development and implementation of scientific projects. • Should be recognized in the scientific community and supplier base through a sustained record of publications and patents. • Should have strong communication skills, both written and oral. • Ability to network and build solid working relationships within and across departments, with diverse and remote staff and with external collaborators from key suppliers. • Ability to think and operate strategically, as well as formulate, write, present and execute well-designed strategies and plans. • Team leadership, management, and facilitation skills are required. • Ability to travel (approx 30%) to other Amgen sites and/or support supplier technical assessments or audits at short notice domestically and overseas.2012-03-16 02:42:34United StatesAmgenCalifornia14115BRCAThousand Oaks, CA27183556http://www.amgen.jobs/xml/27183556/jobUSAThousand OaksAuto req 10371BR Job Posting Title Principal Engineer - Primary Container Manufacturing Career Category Operations Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description Primary Container Manufacturing and Device Mechanical Engineer The successful candidate for this position is required to provide hands-on technical leadership to primary container mechanical design. Job responsibilities will be primarily focused on; 1. Leading the characterization of mechanical interfaces / interactions of primary containers with equipment and devices, 2. Development of test methods for mechanical characteristics, 3. Produce models and drawings using Solid Works, 4. Perform basic engineering analysis such as tolerance stack up and FMEAs, 5. Develop and leverage a basic working knowledge of relevant manufacturing processes to apply Design for Manufacturability 6. Develop and execute test protocols and publish associated reports 7. Support the maintenance and creation of Design History Files in accordance with established Company's Product Development Process This role will be required to collaborate extensively with external suppliers and Drug Delivery/Device teams This position may have supervisory opportunities and responsibilities for technical personnel. This 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. Basic Qualifications • Doctorate degree & 2 years of directly related experience OR • Master’s degree & 6 years of directly related experience OR • Bachelor’s degree & 8 years of directly related experience OR • Associate’s degree & 10 years of directly related experience OR • High school diploma / GED & 12 years of directly related experience Preferred Qualifications • Ph. D. in Materials Science or Mechanical Engineering with 5 or more years of experience in the Pharmaceutical/Biotechnology industry, Medical Device industry. • Experience to include materials processing, mechanical design, physical characterization of glass and plastic systems, statistical process control (SPC), and design of experiments (DOE). • Strong problem solving, trouble shooting, and communication skills are preferred. • Ability to coach junior engineers, participate in global cross-functional teams, and work effectively in a highly matrix environment. • Familiarity with cGMPs, regulatory filings and compliance issues for sterile injectable products manufactured by aseptic filling processing. • Experience in managing multiple projects simultaneously, strategically prioritizing activities, and leading cross functional teams.2012-03-14 03:14:34United StatesAmgenCalifornia10371BRCAThousand Oaks, CA27126960http://www.amgen.jobs/xml/27126960/jobUSAThousand OaksAuto req 14269BR Job Posting Title Director, Design Assurance - Drug Delivery Career Category Operations Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen 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. The 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. Key Responsibilities: • 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. • Ensure team works closely with product development engineering and the client team to establish the system design specifications and product requirements. • 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. • 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. • Participates with the engineering team to establish and review the design FMEA, FMECA and other risk related activities (ISO14971). • 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. • 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. Basic Qualifications • Doctorate degree & 4 years of directly related experience OR • Master’s degree & 8 years of directly related years OR • Bachelor’s degree & 10 years of directly related experience AND • 4 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources Preferred Qualifications • 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. • 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. • Certified Quality Assurance professional with 3+ years of direct experience in Quality. • CQA, CQM, Six Sigma Black Belt preferred. • ASQ Certified Quality Manager (CQM), Certified Quality Engineer (CQE), or Certified Auditor credentials (e.g., ISO 13485). • Lean and or Six Sigma Certification. • Previous experience in DA engineering and commercialization process with drug delivery devices and combination drug/device products is desired • 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). • Minimum of 8+ years experience working in the development of electro-mechanical systems design, verification and validation. • Microcontroller based firmware experience, Real time OS and SW design test, verification and validation experience (unit, static, dynamic and Cyclomatic complexity analysis). • Ability to write software test cases, protocols, and reports. • Experience with circuit design, analysis, troubleshooting, and testing. • Familiar with PCB/PCA assembly and fabrication. • Strong background with requirements management, configurations management, defect tracking, and requirements tracing tools • Advanced problem-solving, risk assessment, statistical analysis, and negotiation skills expected. • Experience with complex, cross-functional development projects. • Experience working with and leading cross-cultural teams. • Proven ability to apply situational leadership concepts across various intra and inter-departmental matters. • Demonstrated time management, decision making, presentation and organization skills. • Ability to converse technically with mechanical, electronic, software, clinical, regulatory, and quality engineering disciplines.2012-03-14 03:14:28United StatesAmgenCalifornia14269BRCAThousand Oaks, CA27126959http://www.amgen.jobs/xml/27126959/jobUSAThousand OaksAuto req 14117BR Job Posting Title Principle Scientist - Plastics, Product and Process Engineering Career Category Operations Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen 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. This 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. Basic Qualifications • Doctorate degree & 2 years of directly related experience OR • Master’s degree & 6 years of directly related experience OR • Bachelor’s degree & 8 years of directly related experience OR • Associate’s degree & 10 years of directly related experience OR • High school diploma / GED & 12 years of directly related experience Preferred Qualifications • PhD in materials science with specialization in polymers, or multiple years in the manufacture of pharmaceutical plastics • Ten years relevant work experience in use of plastics materials in biopharmaceutical applications • Knowledge of license applications and the drug development process • Familiarity with all aspects of the use of plastics in biopharmaceutical applications, current state of the art technologies and emerging scientific directions. • Leadership experience of progressively increased scope. • Strong interdisciplinary project management skills. • Ability to independently uncover and resolve issues associated with the development and implementation of scientific projects. • Should be recognized in the scientific community and supplier base through a sustained record of publications and patents. • 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. • Ability to think and operate strategically, as well as formulate, write, present and execute well-designed strategies and plans. • Team leadership, management, and facilitation skills are required. Should be willing to travel (approx 30%) to other Amgen sites and/or support supplier technical assessments or audits at short notice domestically and overseas. • Extensive knowledge of the manufacturing processes, usage, regulatory requirements, practices, scientific properties and risks associated with the raw materials for pharmaceutical and biological products.2012-03-02 18:37:59United StatesAmgenCalifornia14117BRCAThousand Oaks, CA26890893http://www.amgen.jobs/xml/26890893/jobUSAThousand OaksAuto req 14072BR Job Posting Title Sr Associate Mfg Career Category Operations Employee Subgroup Hourly FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen 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. • Initiate, revise, and approve manufacturing procedures. Ensure all procedures reflect current operations. Serve as a document owner. • Evaluate, plan, and implement solutions for process improvement opportunities. • Provide troubleshooting support. • Assist in generation of training materials and may assist in providing training on scientific or technical aspects of the process. • Assist with managing investigation closure within established goal. • Assist with equipment/system Root Cause Analysis investigations and support trend evaluations. • Participate in the New Product Introduction process to assess requirements for documentation, materials, training, and equipment modifications. • Assist manufacturing change owner on Change Control packages impacting the process. • Train operations personnel on new processes or changes to process • Assist with overseeing engineering studies • Prepare, review, approve, and provide technical support for preparation and execution of relevant technical documents, as required. Basic Qualifications • Master’s degree OR • Bachelor’s degree & 2 years of directly related experience OR • Associate’s degree & 6 years of directly related experience OR • High school diploma / GED & 8 years of directly related experience Preferred Qualifications • Bachelor’s degree in Mechanical Engineering with 2 or more years of experience in biopharma. • Demonstrated ability organizing and leading projects • Experience working within biopharma formulation and filling of parenteral products • Clear understanding of cGMPs. • Strong computer skills. • Strong cross functional communication • Light to moderate lifting and carrying of 15-44lbs, reach above and below shoulder height. • Knowledge of aseptic, barrier (RABs), or isolator technology for parenteral filling operations. • Experience working hands on with equipment and processes and to train other technical staff and operators.2012-03-01 23:11:26United StatesAmgenCalifornia14072BRCAThousand Oaks, CA26874101http://www.amgen.jobs/xml/26874101/jobUSAThousand OaksAuto req 14067BR Job Posting Title Associate Mfg Career Category Operations Employee Subgroup Hourly FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen 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. Will need to be available to work non-standard shifts, evenings and/or weekends. Major duties will include: • Operation of the fill/stoppering equipment to dispense sterile product into glass containers • Environmental monitoring of the aseptic environment during each fill and after each fill • Loading and unloading of sterile products from freeze dryers • Operation of the continuous particulate monitoring system during each fill • Assembling and disassembling of equipment before and after use • Performing operations during fills by following proper procedures • High levels of housekeeping to conform to cGMP standards • Cleaning and sanitizing aseptic filling areas to maintain the quality of the product • Detailed and accurate documentation in batch production records. • Able to determine availability of components and assign accordingly. • May also be required to assist in training of co-workers. • Able to perform in the aseptic filling areas while maintaining the integrity and cleanliness of these areas by utilizing aseptic gowning requirements and techniques. Basic Qualifications • Bachelor’s degree OR • Associate’s degree & 4 years of directly related experience OR • High school diploma / GED & 6 years of directly related experience Preferred Qualifications • Bachelors Degree in Mechanical Engineering, or Technology. • Exposure to aseptic filling, biopharma manufacturing equipment, trouble shooting and moving machinery. • 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. • cGMP manufacturing experience including mechanical ability/expertise. • Demonstrate technical writing capability. • Demonstrate project management skills, presentation skills, and be able to independently collaborate with outside resources.2012-03-01 23:11:11United StatesAmgenCalifornia14067BRCAThousand Oaks, CA26874098http://www.amgen.jobs/xml/26874098/jobUSAThousand OaksAuto req 14074BR Job Posting Title Dir Engineering - Human Factors and Industrial Design - Drug Delivery Career Category Operations Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen 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. The 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. The 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. Ensures • Human-system capabilities and limitations are properly reflected in the system requirements • 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) • Human-system performance and safety risks are appropriately addressed in program baseline • Determine the human factors cost, benefit, schedule, and performance baselines for each candidate solution • 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) • 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 • 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 The 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. Basic Qualifications • Doctorate degree & 4 years of applied HF/ID engineering experience OR • Master’s degree & 8 years of applied HF/ID engineering experience OR • Bachelor’s degree & 10 years of applied HF/ID engineering experience AND • 4 years of engineering managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources Preferred Qualifications • 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. • MS in Human Factors, Industrial Design, Cognitive Psychology, or other Engineering/Life Sciences related discipline • 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). • Minimum of 8+ years experience working in the development of electro-mechanical systems design, verification and validation • Strong background with requirements management, configurations management, defect tracking, and requirements tracing tools • Advanced problem-solving, risk assessment, statistical analysis, and negotiation skills expected • Experience with complex, cross-functional development projects • Experience working with and leading cross-cultural teams • Proven ability to apply situational leadership concepts across various intra and inter-departmental matters • Demonstrated time management, decision making, presentation and organization skills • Previous experience in HF/ID engineering and commercialization process with drug delivery devices and combination drug/device products is desired • 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) • Ability to converse technically with mechanical, electronic, software, clinical, regulatory, and quality engineering disciplines The position requires also requires the following: • Proven experience in the HF/ID principles/methods of human-centered design, observational research, ergonomic design, human/machine interface, and data collection/analysis • Proven experience with using sketch models, low and high fidelity prototypes to identify and eliminate potential use errors early in the development process • Experience working directly with customers to gather, synthesize and convert user research into concepts that differentiate products in the market • Experience working directly with customers to develop and evaluate new product features, user interfaces and ergonomic designs, and with ensuring customer satisfaction • Thorough knowledge of relevant human factors regulations, standards and guidance for medical devices and pharmaceutical packaging • 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. • 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 • Experience in writing human factors engineering protocols and reports as support for registration documentation (e.g. Usability engineering reports) • Proven leadership and experience managing multiple projects with high demand schedules • Experience in management of external partners • Experience with establishing departmental or program objectives following company policies and establishing procedures that are measureable with outcomes can be quantified2012-02-25 18:46:50United StatesAmgenCalifornia14074BRCAThousand Oaks, CA26756596http://www.amgen.jobs/xml/26756596/jobUSAThousand OaksAuto req 13873BR Job Posting Title Manufacturing Specialist - NPI/Packaging Career Category Operations Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description This role will work within the New Product Introduction group of Amgen’s ATO Fill and Packing Organization and will be a key process leader in the introduction of new products within the Packaging department. The 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. Additional responsibilities will include routine interaction with key quality and manufacturing systems, as well as with Operational Excellence (OE) initiatives, and global networks. Areas of scope and responsibilities include but are not limited to: • Supporting/Leading New Product Introductions (NPIs) • Ability to write, revise, and own manufacturing documentation (SOPs, Manufacturing Procedures, Device requirements (MPs), Forms) • Owner/lead author for Non-Conformances (NC’s), Corrective and Preventive Actions (CAPA’s), and Change Controls records that occur in association with the new product introduction process. • 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 • 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 • Work closely with Quality, Engineering, Process Development, Validation, and Operations to resolve project management issues in a timely manner • Assure appropriate escalation to various levels of management when timeline requirements for new product introduction are at risk or exceeded • Collaborate with Quality, Mfg Managers, Plant Engineering, Process Development and Regulatory Compliance staff in cross-functional teams • Apply advanced process, operational, scientific expertise, compliance knowledge and analytical and troubleshooting skills to support manufacturing operations • Manage generation and presentation of key operating metrics for functional area • Provide training to manufacturing staff in support of new product introduction where appropriate Basic Qualifications • Doctorate degree OR • Master’s degree & 3 years of directly related experience OR • Bachelor’s degree & 5 years of directly related experience OR • Associate’s degree & 10 years of directly related experience OR • High school diploma / GED & 12 years of directly related experience Preferred Qualifications Bachelor’s degree & 5 years of directly related experience in a biotech/pharma manufacturing or manufacturing support role (ie process development, engineering, quality) • Project management experience • Detailed technical understanding of packaging operations • Experience participating in and leading cross-functional teams • Experience in managing multiple, competing priorities in a fast-paced environment • Strong technical writing and verbal presentation skills • Ability to be flexible and manage change • Ability to effectively communicate complex technical information with internal and external colleagues of varying organizational levels in both presentation and technical writing forms • Ability to communicate/manage upwards to high level stake holders (Director and above) • Highly detailed orientated • Exceptional organizational skill • Experience with a Current Good Manufacturing Practices (cGMP) • Experience with change control and non-conformance management systems/processes Preferred Qualifications: • Extensive technical knowledge of drug product packaging, drug product delivery devices, and a broad understanding of related disciplinary areas • Experience interacting with representatives of regulatory agencies • Detailed technical understanding of packaging operations • Strong experience with Microsoft Office suite - PowerPoint, Word, Outlook • Advanced Microsoft Excel experience in the management/analysis of data; including use of Excel Pivot Tables and advanced Excel chart management (formula statements, etc) • Strong experience with Microsoft SharePoint environment including the creation and management of Ninetex workflow • Ability to organize, analyze, and interpret technical data through trend analysis, forecasting, modeling, etc. • Understands the core functional business processes and their role in Amgen's commercialization program2012-02-16 21:59:19United StatesAmgenCalifornia13873BRCAThousand Oaks, CA26576291http://www.amgen.jobs/xml/26576291/jobUSABoulderAuto req 13823BR Job Posting Title Sr Engineer - Mfg Projects Career Category Operations Employee Subgroup Salaried FT Country (State/Region) United States - Colorado Location (City) Boulder Amgen Job Description Amgen Colorado’s Engineering team is responsible for delivering capital and expense improvement projects to our client’s 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. The 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. • Supports the project team during engineering studies geared toward developing the technical and business justification for engineering projects. • Work with clients and stakeholders from manufacturing, process development, facilities, quality assurance and validation to develop and define user requirements. • Responsible for identifying and refining design alternatives during conceptual schematic design evaluations. • Responsible for executing and/or directing, coordinating and supervising the work of consultants and engineering firms during the schematic and detailed design phases. • Executes and/or directs technical resources during the implementation phase (includes construction, startup, commissioning, and validation). • Responsible for turnover packages prepared during the detailed design phase and project close out. • Responsible in ensuring that all Amgen standards and procedures are followed by the project team. • Verifies that all change control procedures are properly documented. • Works closely with other discipline and/or project engineers to coordinate the design and implementation. • May work in as a discipline or project engineer depending on the needs of each project. Basic Qualifications • Doctorate degree OR • Master’s degree & 3 years of directly related experience OR • Bachelor’s degree & 5 years of directly related experience OR • Associate’s degree & 10 years of directly related experience OR • High school diploma / GED & 12 years of directly related experience Preferred Qualifications Bachelor degree in Engineering and 8+ years of related engineering experience with four of those years engaged in projects in a manufacturing environment. Demonstrated 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. Demonstrated 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. ? Experience with design and implementation in a manufacturing environment, and with validation and change control methodology strongly desired. ? Knowledge and skills in Microbial and Mammalian Fermentation, Cell Culture and Purification systems strongly desired. ? Demonstrated leadership experience ? Project management experience ? Technology transfer experience ? Knowledge of cGMP pharmaceutical manufacturing process design requirements. ? High level experience with design, programming, and commissioning activities for all automation/process systems and controllers (such as SLC, PLC, DeltaV, BMS, HMI & SCADA). ? 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.2012-02-10 18:16:30United StatesAmgenColorado13823BRCOBoulder, CO26456571http://www.amgen.jobs/xml/26456571/jobUSASeattleAuto req 13373BR Job Posting Title Scientist - Biotech Engineering Career Category Operations Employee Subgroup Salaried FT Country (State/Region) United States - Washington Location (City) Seattle Amgen 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. The 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 regulatory filings. Travel will be required. Basic Qualifications • Doctorate degree OR • Master’s degree & 3 years of directly related experience OR • Bachelor’s degree & 5 years of directly related experience OR • Associate’s degree & 10 years of directly related experience OR • High school diploma / GED & 12 years of directly related experience Preferred 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. Ability 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. Experience with process development for biologics including lyophilization cycle development. Experience participating in global, cross-functional teams working on technology transfer of biologics.2012-02-08 02:38:38United StatesAmgenWashington13373BRWASeattle, WA26389646http://www.amgen.jobs/xml/26389646/jobUSAThousand OaksAuto req 12623BR Job Posting Title Sr Engineer - Facilities/Utilities Career Category Operations Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description • 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. • 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). • 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. • 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.) • Support new product introductions or new technology introductions by performing engineering assessments, implementing equipment modifications, and supporting engineering runs. • 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. • 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. • 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. • Support a safe working environment by complying with all pertinent environmental health/safety practice, rules and regulations. Basic Qualifications Doctorate degree OR Master’s degree & 3 years of experience directly related to the job OR Bachelor’s degree & 5 years of experience directly related to the job OR Associate’s degree & 10 years of experience directly related to the job OR High school diploma / GED & 12 years of experience directly related to the job Preferred Qualifications • Bachelor’s degree in Chemical Engineering or Mechanical preferred • 6+ years of relevant work experience with 5+ years experience in operations/manufacturing environment • 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. • Hands-on experience with manufacturing process equipment including advanced troubleshooting, reliability and performance improvements, and design optimization. • 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. • Strong leadership, technical writing, and communication/presentation skills are required. • Work schedule flexibility as required to support 24/7 operations, requiring occasional after-hours engineering coverage. • 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. • 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. • 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. • 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.2011-11-01 22:17:20United StatesAmgenCalifornia12623BRCAThousand Oaks, CA24526977http://www.amgen.jobs/xml/24526977/jobUSAThousand OaksAuto req 12624BR Job Posting Title Sr Engineer - Process Equipment Career Category Operations Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description • 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. • 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. • 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. • 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. • Support a safe working environment by complying with all pertinent environmental health/safety practice, rules and regulations. • 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). • 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. • 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.) • Support new product introductions or new technology introductions by performing engineering assessments, implementing equipment modifications, and supporting engineering runs. Basic Qualifications Doctorate degree OR Master’s degree & 3 years of experience directly related to the job OR Bachelor’s degree & 5 years of experience directly related to the job OR Associate’s degree & 10 years of experience directly related to the job OR High school diploma / GED & 12 years of experience directly related to the job Preferred Qualifications • Master’s degree in Chemical Engineering or Bioengineering preferred • 8+ years of relevant work experience with 7+ years experience in operations/manufacturing environment • 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. • Direct experience in equipment engineering and troubleshooting with fermentors, bioreactors, centrifuges, chromatography columns and systems, and/or ultrafiltration/diafiltration systems. • Hands-on experience with manufacturing process equipment including advanced troubleshooting, reliability and performance improvements, and design optimization. • 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. • Strong leadership, technical writing, and communication/presentation skills are required. • Work schedule flexibility as required to support 24/7 operations, requiring occasional after-hours engineering coverage. • 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. • 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. • 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.2011-11-01 22:17:12United StatesAmgenCalifornia12624BRCAThousand Oaks, CA24526976http://www.amgen.jobs/xml/24526976/jobUSAThousand OaksAuto req 11568BR Job Posting Title Associate Engineer - Drug Delivery Systems Career Category Operations Employee Subgroup Hourly FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen 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. Basic Qualifications • Bachelor’s degree OR • Associate’s degree & 4 years of directly related experience OR • High school diploma / GED & 6 years of directly related experience Preferred Qualifications BS degree in Mechanical Engineering, or other Engineering/Life Sciences 3 years of experience in engineering specific to the device or biotech/pharmaceutical industry. 3 years experience with device design, production and validation Knowledge of device development, manufacturing and test equipment, injection molding, and material science is important to the position. The 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. Independent thinker with demonstrated skills working in teams or leading project teams.2011-07-29 19:29:32United StatesAmgenCalifornia11568BRCAThousand Oaks, CA22717361http://www.amgen.jobs/xml/22717361/job