[{"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 15741BR\nJob Posting Title Sr Engineer\nCareer Category Operations\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description Serve as a technical expert on a drug product team to support commercialization and trouble shooting of manufacturing process. Activities will pertain to process design, scale-up, characterization and technology transfer of drug product manufacturing operations for validation and registration of protein parenteral products.\n\nThe responsibilities include designing and executing bench and pilot scale experimentation, applying sound scientific theory to experimental work, and optimizing various unit operations including protein freeze/thaw, ultrafiltration/diafiltration, formulation, sterile filtration, mixing, vial and syringe filling and lyophilization. Also conducts experiments, analyzes data, writes technical reports and assessments, and communicates frequently with management and team members. She/he serves as a reliable technical resource for clinical manufacturing support and scale-up of drug product operations for commercial production. The candidate will need to participate in cross-functional teams and work effectively in a highly matrixed team environment.\nBasic Qualifications \u2022 Doctorate degree\nOR\n\u2022 Master\u2019s degree & 3 years of directly related experience\nOR\n\u2022 Bachelor\u2019s degree & 5 years of directly related experience\nOR\n\u2022 Associate\u2019s degree & 10 years of directly related experience\nOR\n\u2022 High school diploma / GED & 12 years of directly related experience\nPreferred Qualifications \u2022 Ph.D. in Chemical Engineering, Biochemical Engineering, Pharmaceutical Sciences, or Life Sciences with a pharmaceutical, vaccine, or biotechnology background with 3 + years experience in biotech/pharmaceutical industry.\n\u2022 Experience with formulation and filling process steps of cryopreservation, lyophilization, vial and syringe filling, sterile filtration, and aseptic processing is preferred.\n\u2022 Experience with statistical analysis, design of experiments, and writing/reviewing technical and manufacturing documents.\n\u2022 Experience with process development for Phase I \u2013 III biologic drug products.\n\u2022 Travel may be required.", "date_new": "2012-05-22 19:47:29", "url": "http://www.amgen.jobs/xml/28868627/job", "country": "United States", "company": "Amgen", "title": "Sr Engineer", "reqid": "15741BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 28868627}, {"country_short": "USA", "city": "Woburn", "description": "Auto req 15596BR\nJob Posting Title Sr Validation Engineer\nCareer Category Engineering\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - Massachusetts\nLocation (City) Woburn\nAmgen Job Description Under general direction provide the coordination and execution of validation activities including (but not limited to) writing protocols, performing qualifications, review of documents that support manufacturing facilities. In addition the candidate will have to have an understanding of how the various pieces of manufacturing equipment operate, and experience in the field of Validation and Engineering. Self motivated individual who can function with minimal directions.\nKey Responsibilities:\n\u2022 Assist with the administrative and execution of Validation plans and validation protocols for major projects on site (facility, manufacturing processes, equipment, cleaning, and software).\n\u2022 Assist with the validation activities for the expansion project.\n\u2022 Prepare and /or revise validation protocols/procedures as required.\n\u2022 Review and execute qualification and summary reports, write and revise as needed.\n\u2022 Participate in review of manufacturing operational SOPs and maintenance for facility and process.\n\u2022 Assist in troubleshooting, complex or usual problems arising from equipment/system failures.\n\u2022 Ensure continuous validation maintenance for facility and process through change control program.\n\u2022 Analyze validation data, prepare reports, and make recommendations for changes and or/improvements.\n\u2022 Represent department in meetings when required.\n\nOther Responsibilities:\n\u2022 Coordinate generation and completion of any deviations, equipment and document change control resulting from a qualification and /or validation activity.\n\u2022 Assist in defining and implementing acceptance criteria, specifications, and standards for each qualification activity.\n\u2022 Interface with manufacturing, technical operation and QC group.\nBasic Qualifications Doctorate degree\n\nOR\n\nMaster\u2019s degree and 3 years of directly related experience\n\nOR\n\nBachelor\u2019s degree and 5 years of directly related experience\n\nOR\n\nAssociate\u2019s degree and 10 years of directly related experience\n\nOR\n\nHigh school diploma / GED and 12 years of directly related experience\nPreferred Qualifications Educational Requirements: Minimum of a BS in Engineering or related technical discipline.\nExperience and Skill Requirements:\n\u2022 6-8+ years experience in the validation of biotechnology or pharmaceutical equipment and processes.\n\u2022 Technical understanding of pharmaceutical/biotechnology unit operations.\n\u2022 Strong communication and interpersonal skills\n\u2022 Good knowledge of cGMP requirements and current industry practices\n\u2022 Demonstrate ability to work in a cross-functional team environment\n\u2022 The ideal candidate will possess excellent planning and coordination skills and be able to readily adapt to changes in priorities and project schedules.", "date_new": "2012-05-09 20:34:40", "url": "http://www.amgen.jobs/xml/28581296/job", "country": "United States", "company": "Amgen", "title": "Sr Validation Engineer", "reqid": "15596BR", "state": "Massachusetts", "state_short": "MA", "location": "Woburn, MA", "uid": 28581296}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 15524BR\nJob Posting Title Engineering Projects Sr Mgr (IS Project Controls)\nCareer Category Engineering\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description The IS Project Controls Senior Manager will be responsible to handle a broad range of projects executed at multiple locations around the world.  The scope of responsibilities span from liaison with corporate management to obtaining project funding, through managing and objectively reporting project status to senior management. Projects typically range in value from a few hundred thousand  dollars to multi million dollars. Project complexity ranges from simple hardware replacement to complete business system replacements. The successful candidate will be the IS project control\u2019s Lead, and will interface with all levels of management across functional areas. The individual in this position will report directly to the Executive Director Engineering Project Controls and via dotted line to the Director Information Systems Business Services.\n\nThe IS Project Controls Senior Manager will be responsible for developing, with the project team, project funding documents, assisting in budget, schedule and change management, cost and schedule risk analysis, cash flow analysis, and developing historical cost data for bench marking purposes. In addition, he/she will review and analyze contractor cost estimates, bids, change orders, invoices, labor rates, physical engineering/construction progress, etc. The IS Project Controls Senior Manager will be responsible for budgeting, tracking and controlling Amgen costs as well as Construction, IS and Automation engineer, vendors and contractor costs.\n\nThe IS Project Controls Senior Manager will also be responsible for sourcing, onboarding, training, and overseeing all of the contingent workers who are assigned to IS projects. In addition, he/she will also lead the standardization of all project control processes to be used in IS.\n\nFunctions (Duties/Accountabilities):\n1. Assist the Project Manager(s) in developing project strategies\n2. Assist in the preparation of Amgen project funding documents\n3. Assist in developing strategies and negotiating pricing for scope of work for subcontractors and vendors such as G-Max, unit pricing, time and material, etc.\n4. . Reviewing and analyzing Construction, IS and Automation engineers, vendors and contractor bids\n5. Evaluate Construction, IS and Automation engineers, vendors and contractors physical progress\n6. Develop and monitor project schedules and cash flow\n7. Develop Construction, IS and Automation engineering, vendors and construction cost forecasts for remaining work\n8. Reviewing, approving Construction, IS and Automation engineers, vendors and contractor buy outs, change orders and invoices\n9. Administrating the closeout of contracts and purchase orders.\n10.Prepare monthly project status reports for senior management\n11 Lead risk analysis reviews for cost estimates, cost forecasts and schedules using applicable software packages.\n12. Project controls resource planning for IS\n13. Development of common project control standards to be used in IS\nBasic Qualifications \u2022 Doctorate degree & 2 years of directly related experience\nOR\n\u2022 Master\u2019s degree & 6 years of directly related experience\nOR\n\u2022 Bachelor\u2019s degree or & 8 years of directly related experience\nOR\n\u2022 Associate\u2019s degree & 10 years of directly related experience\nOR\n\u2022 High school diploma / GED & 12 years of directly related experience\nPreferred Qualifications \u2022 Bachelors Degree in Engineering, Technology or Life Sciences\n\u2022 8 + years of experience in commercial and/or industrial construction in project controls: i.e. cost control, scheduling and estimating\n\u2022 5 + years in biotechnology/pharmaceutical industries\n\u2022 Experience in IS systems supporting global/multiple sites\n\n\u2022 Proficiency in using SAP, CPM Scheduling and @ Risk software\n\u2022 Proven ability to manage and deliver results in a highly fluid, interactive matrix environment\n\u2022 Commercial and/or industrial construction experience could include: strong technical knowledge in construction cost and schedule management. In addition, have strong analytical skills for estimate analysis, bid evaluations, budget monitoring, cash flow analysis, risk analysis and benchmarking project costs. The individual must have a good understanding of all types of estimating from conceptual through definitive construction estimates\n\u2022 Lean Construction, Six Sigma certifications and/or other continuous improvement methods", "date_new": "2012-05-08 18:40:38", "url": "http://www.amgen.jobs/xml/28541246/job", "country": "United States", "company": "Amgen", "title": "Engineering Projects Sr Mgr (IS Project Controls)", "reqid": "15524BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 28541246}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 15356BR\nJob Posting Title Sr Engineer - Drug Process Development\nCareer Category Operations\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description Provide process development technical support to protein drug product manufacturing at Amgen contracted manufacturing sites including process performance; implementation of process improvement strategies; development of process models.\n\n\u2022 Act as a drug product contract manufacturing technical expert and team leader to provide leadership and solutions when troubleshooting drug substance freezing/thawing, formulation, filling vials/syringes/devices, lyophilization, inspection, and transportation, for protein parenteral products.\n\u2022 Provide process development expertise for commercial drug product processing in specific areas such as Sterile processing, Process Characterization, Tech Transfer and Validation. Support commercial drug product manufacturing operations with technical evaluation of NC/CAPA, scale up, validation, and technology transfer.\n\u2022 Troubleshoot issues with drug product processing technologies and equipment.\n\u2022 Develop and characterize drug product processes and transfer technology to commercial drug product sites.\n\u2022 Conduct risk assessment for drug product operations and propose / implement appropriate CAPA.\n\u2022 Identify and implement operational opportunities for current and new sterile operations.\n\u2022 Responsibilities may include leading cross-site teams to support the above activities, providing recommendations to management.\n\u2022 Travel to domestic and international contract manufacturing sites required\nBasic Qualifications \u2022 Doctorate degree\nOR\n\u2022 Master\u2019s degree & 3 years of directly related experience\nOR\n\u2022 Bachelor\u2019s degree & 5 years of directly related experience\nOR\n\u2022 Associate\u2019s degree & 10 years of directly related experience\nOR\n\u2022 High school diploma / GED & 12 years of directly related experience\nPreferred Qualifications \u2022 M.S. in Science or Chemical Engineering and 6 + years of experience in support of Commercial Protein Drug Product (DP) processing in specific areas such as Sterile Processing, Process Characterization, Tech Transfer (to commercial DP sites) or Validation.\n\u2022 Strong skills in applying fundamental engineering and scientific principles to the design and implementation of protein freeze-thawing, filtration, mixing, filling, and/or lyophilization processes. Knowledge of protein biochemistry with regard to chemical and physical stability is strongly desired. Excellent written and verbal communication skills.\n\u2022 Project management skills including the ability to manage multiple projects and evaluate project resource requirements.\n\u2022 Strong knowledge of Quality systems, Drug Product Manufacturing and Validation.\n\u2022 Demonstrated ability in providing leadership to cross-functional teams to advance complex projects to completion.", "date_new": "2012-04-24 20:51:14", "url": "http://www.amgen.jobs/xml/28152785/job", "country": "United States", "company": "Amgen", "title": "Sr Engineer - Drug Process Development", "reqid": "15356BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 28152785}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 14554BR\nJob Posting Title Sr Packaging Engineer\nCareer Category Operations\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description This position reports into the Primary Container Engineering group under Drug Product Engineering in Thousand Oaks. This position will be required to apply advanced and diverse engineering principles to execute the proper design, qualification and implementation of Primary Packaging components and the associated systems such as documentation, equipment and processes. Knowledge of primary packaging systems and processes, manufacturing fill/finish equipment and processes, material science and quality system is essential to the position.\n\nThis position is responsible and accountable for the following:\n1) Evaluation, recommendation and selection of primary packaging materials for large and small molecule drug products.\n2) Write test and execute protocols, perform technical evaluations and submitting technical assessment reports to justify the use of selected materials.\n3) Write Technical Specifications and Bill of Materials\n4) Representing Primary Container Engineering in Drug Product and Global Operation Teams\n5) Technology transfer from clinical to commercial or from site to site for both packaging components and equipment processes\n6) Ensures that required line trials and packaging validation is conducted prior to introduction of any new or change in components/processes\n7) Ensures cGMP and regulatory compliance are met\n8) Ensures that change control procedures are followed working with QA and Regulatory to implement changes\n9) Author primary container sections for all global market applications and support filing activities\n10) Participants in Pre-Approval Inspections (PAI) and interact with regulatory bodies (e.g., FDA, EMEA, etc) as needed\n11) Collaborates with cross-functional teams (i.e. Research, QA/QC, Supply Chain, Maintenance, Manufacturing, Regulatory, etc.) in pre-commercial and commercial activities.\n12) Assess, develops, and implements solutions for complex problems relating to packaging or packaging systems.\n13) Oversees project implementation of critical new package platforms.\nBasic Qualifications \u2022 Doctorate degree\nOR\n\u2022 Master\u2019s degree & 3 years of directly related experience\nOR\n\u2022 Bachelor\u2019s degree & 5 years of directly related experience\nOR\n\u2022 Associate\u2019s degree & 10 years of directly related experience\nOR\n\u2022 High school diploma / GED & 12 years of directly related experience\nPreferred Qualifications MS in Engineering or Life Sciences\n5 to 7 of packaging engineering experience with 4+ years within the Pharma/Bio industry\nThe position requires excellent organizational, project management, technical problem solving and communication (written and verbal) skills, the ability to work in multi-functional teams and adapt to rapidly changing environment.", "date_new": "2012-04-11 22:06:59", "url": "http://www.amgen.jobs/xml/27821397/job", "country": "United States", "company": "Amgen", "title": "Sr Packaging Engineer", "reqid": "14554BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 27821397}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 15113BR\nJob Posting Title Sr Systems Engineer\nCareer Category Operations\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description The Sr Systems Engineer (SE) leads small to mid-sized cross-functional program teams to deliver the technical content, performance, intellectual property and quality deliverables of an NPI program. The SE drives the architecture, vision and design requirements for the product all the time balancing implementation complexity, risks, manufacturability, serviceability and quality. The SE must understand and capture the user needs into system requirements and is responsible for the architectural decomposition and allocation to subsystems. The SE ensures that the quality targets are satisfied and retires technical risks as they arise on the program. The SE maintains close interaction with customers to understand and enhance the ability to deliver customer satisfaction through higher product quality.\n\nEnsuring that the quality targets are satisfied and retires technical risks as they arise on the program. Leading the design team and design control process from requirements development and design planning to design transfer. Leading the design team in the development of verification and validation planning and execution. Developing requirements flow down, architecture/system design and analysis, risk analysis, integration and test, manufacturing, field and customer support including corrective and preventative actions to ensure customer satisfaction. Create and maintain artifacts (models, diagrams, documents) by evaluating needs, clarifying requirements, and analyzing use cases and dependencies to functional specifications to support hardware and software development at system and component level. Driving the architecture, vision and design requirements for the product all the time balancing implementation complexity, risks, manufacturability, serviceability and quality to evaluate and select optimum design alternatives.\n\nAccountability:\n\u2022 Analyze problems involving cross-disciplinary aspects of the product development process, synthesize multiple disciplinary solutions. Develop and exploit structured, efficient approaches to analysis and design to solve complex engineering problems.\n\u2022 Provide direction and support for the optimal design of complex, large scale systems through consideration of the system as a whole, rather than individual components of the system.\n\u2022 Provide various client areas with accurate and consistent requirements information to help them make critical technical decisions based on complete and unambiguous insight into cross-systems functionality.\n\u2022 Ensure compliance/closure of Regulatory and Quality requirements before approving Design Control FDRs and NPI program milestones.\n\u2022 Conduct and review advanced computer simulations to design or test products.\n\u2022 Prepare cost estimates on proposed major design products.\n\u2022 Provide technical presentation support and consultation to marketing.\n\u2022 Represent company unit in customer or field force contacts.\n\u2022 Recommend the addition, expansion or termination of research projects and assure the technical soundness of engineering programs.\n\u2022 Produce innovative technical solutions to customers.\n\u2022 Prepare technical proposals for competitive bids.\n\u2022 Develop potential applications to exploit new business opportunities.\n\u2022 Collect and analyze information on competitor product performance.\n\u2022 Utilize project planning and monitoring methods to ensure timely completion.\n\u2022 Originate and communicate concepts which could lead to new products.\n\u2022 Review and approve completed design work.\n\u2022 Actively contributes to identifying and pursuing new technological opportunities\nBasic Qualifications \u2022 Doctorate degree\nOR\n\u2022 Master\u2019s degree & 3 years of directly related experience\nOR\n\u2022 Bachelor\u2019s degree & 5 years of directly related experience\nOR\n\u2022 Associate\u2019s degree & 10 years of directly related experience\nOR\n\u2022 High school diploma / GED & 12 years of directly related experience\nPreferred Qualifications Masters Degree in Engineering and 5 years progressive experience as an engineer or scientist working with Medical Devices, ideally Class II and Class III\n\n\u2022 Demonstrated experience driving CTQ hierarchical decomposition (flow-down) to subsystems and components.\n\u2022 Demonstrated ability to work with technical leadership team to implement product platform/subsystem multi-generation technology plan for a specific release of a global program/product.\n\u2022 Demonstrated broad exposure to HW/SW/Systems design and technical depth in one or more engineering disciplines (Electrical, Mechanical, Software, etc).\n\u2022 Experience in model-based design and UML and Small scale device assembly experience.\n\u2022 Experience in system design and architecture that ensure product development success and ensuring Accurate Development Cycles between teams.\n\u2022 Leadership ability for System Level Design and Testing (Verification and Validation testing of System Level Performance)\n\u2022 Experience in leading system hazard analysis, risk evaluation, and FMECA (failure mode and effect criticality analysis)\n\u2022 Experience in resolving system engineering issues such as device hardware/firmware or device/programmer system architecture design tradeoffs, tolerance/performance analysis, etc.\n\u2022 Deep knowledge of Quality Management System, Quality Management Policy and applicable laws and regulations as they apply to this job type/position\n\u2022 Familiar with the following standards:\nUS Good Manufacturing Practices \u2013 21CFR820\nQuality Management \u2013 ISO 13485\nRisk Management \u2013 ISO 14971\nEU Medical Device requirements \u2013 Council Directive 93/42/EEC\nMedical Electrical Equipment \u2013 EN 60601\n\u2022 Strong background in documenting requirements and providing traceability documentation for FDA Approval - DOORS, Requisite Pro, or other similar requirements management software.\nexperience highly desired\n\u2022 Practical experience in configuration management and change control process/requirements \u2013 CCB (change control board), CIT (change implementation team) concepts\n\u2022 Experience working with cross department teams to analyze feasibility and ensure that all systems are being built in consideration with one another\n\u2022 Experience in leading continuous improvement activities by driving the implementation of process and product quality improvement initiatives.\n\nDesired Characteristics\n\u2022 Demonstrated applied lean 6 Sigma competency\n\u2022 Demonstrated experience with NPI ISO and regulatory compliance process, design history file and collaterals are in place and current.\n\u2022 Creative problem solver and solution developer when presented with conflicting requirements, business demands and technical risks/issues.\n\u2022 Demonstrated skills in proactively identifying, facilitating and driving closure of a product/program.\n\u2022 Strong interpersonal skills\n\u2022 Demonstrated skills in proactively identifying, facilitating and driving closure of a product/program\n\u2022 INCOSE certification or formal Systems Engineering training/certification", "date_new": "2012-04-06 21:46:17", "url": "http://www.amgen.jobs/xml/27706661/job", "country": "United States", "company": "Amgen", "title": "Sr Systems Engineer", "reqid": "15113BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 27706661}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 15121BR\nJob Posting Title Sr Packaging Engineer\nCareer Category Operations\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description This position reports into the Device & Package Engineering (D&PE) group under Global Drug Product and Device Development in Thousand Oaks, CA. The position falls within 2 different categories in D&PE: Pre-Commercial and Commercial Engineering, supporting global supply, launch delivery, partnerships/acquisitions and devices.\n\nThis position will apply advance and diverse engineering principles to execute the design, qualification and implementation of Primary and Secondary Packaging components and the associated systems such as documentation, equipment and processes. Knowledge of primary and secondary packaging systems and processes, manufacturing fill/finish equipment and processes, material science and quality system is essential to the position. This role requires excellent organizational, project management, technical problem solving and communication (written and verbal) skills, and the ability to work in teams and adapt to rapidly changing environment.\n\nThis position is responsible and accountable for the following:\n- Evaluation, recommendation and selection of primary and secondary packaging materials for both large and small molecules product.\n- Write tests protocols, perform technical evaluations and submitting technical assessment reports to justify the use of selected materials.\n- Write Technical Specifications and Bill of Materials\n- Representing PD&E in Drug Product and Global Operation Teams\n- Technology transfer from clinical to commercial or from site to site for both packaging components and equipment processes\n- Ensures that line trials and packaging validation is conducted prior to introduction of any new or change in components/processes\n- Ensures cGMP and regulatory compliance are met\n- Ensures that change control procedures are followed working with QA and Regulatory to implement changes\n- Participants in Pre-Approval Inspections (PAI) and interact with regulatory bodies (e.g., FDA, EMEA, etc) as needed\n- Collaborates with cross-functional teams (i.e. Research, QA/QC, Supply Chain, Maintenance, Manufacturing, Regulatory, etc.) in pre-commercial and commercial activities.\n- Assess, develops, and implements solutions for complex problems relating to packaging or packaging systems.\n- Oversees project implementation of critical new package platforms.\nBasic Qualifications \u2022 Doctorate degree\nOR\n\u2022 Master\u2019s degree & 3 years of directly related experience\nOR\n\u2022 Bachelor\u2019s degree & 5 years of directly related experience\nOR\n\u2022 Associate\u2019s degree & 10 years of directly related experience\nOR\n\u2022 High school diploma / GED & 12 years of directly related experience\nPreferred Qualifications - MS in Packaging, Engineering or Life Sciences\n- 7 or more years of packaging/engineering experience with 4+ years within the Pharma/Bio industry\nDemonstrated Competencies/Skills:\n- Independent thinker with demonstrated skills working in teams or leading\nproject teams\n- Strong Interpersonal and communication skills", "date_new": "2012-04-05 19:45:29", "url": "http://www.amgen.jobs/xml/27668150/job", "country": "United States", "company": "Amgen", "title": "Sr Packaging Engineer", "reqid": "15121BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 27668150}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 14574BR\nJob Posting Title Sr Packaging Engineer\nCareer Category Operations\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description This position reports into the Device & Package Engineering (D&PE) group under Global Drug Product and Device Development in Thousand Oaks, CA. The position falls within 2 different categories in D&PE: Pre-Commercial and Commercial Engineering, supporting global supply, launch delivery, partnerships/acquisitions and devices.\n\nThis position will apply advance and diverse engineering principles to execute the design, qualification and implementation of Primary and Secondary Packaging components and the associated systems such as documentation, equipment and processes. Knowledge of primary and secondary packaging systems and processes, manufacturing fill/finish equipment and processes, material science and quality system is essential to the position. This role requires excellent organizational, project management, technical problem solving and communication (written and verbal) skills, and the ability to work in teams and adapt to rapidly changing environment.\n\nThis position is responsible and accountable for the following:\n- Evaluation, recommendation and selection of primary and secondary packaging materials for both large and small molecules product.\n- Write tests protocols, perform technical evaluations and submitting technical assessment reports to justify the use of selected materials.\n- Write Technical Specifications and Bill of Materials\n- Representing PD&E in Drug Product and Global Operation Teams\n- Technology transfer from clinical to commercial or from site to site for both packaging components and equipment processes\n- Ensures that line trials and packaging validation is conducted prior to introduction of any new or change in components/processes\n- Ensures cGMP and regulatory compliance are met\n- Ensures that change control procedures are followed working with QA and Regulatory to implement changes\n- Participants in Pre-Approval Inspections (PAI) and interact with regulatory bodies (e.g., FDA, EMEA, etc) as needed\n- Collaborates with cross-functional teams (i.e. Research, QA/QC, Supply Chain, Maintenance, Manufacturing, Regulatory, etc.) in pre-commercial and commercial activities.\n- Assess, develops, and implements solutions for complex problems relating to packaging or packaging systems.\n- Oversees project implementation of critical new package platforms.\nBasic Qualifications \u2022 Doctorate degree\nOR\n\u2022 Master\u2019s degree & 3 years of directly related experience\nOR\n\u2022 Bachelor\u2019s degree & 5 years of directly related experience\nOR\n\u2022 Associate\u2019s degree & 10 years of directly related experience\nOR\n\u2022 High school diploma / GED & 12 years of directly related experience\nPreferred Qualifications - MS in Packaging, Engineering or Life Sciences\n- 7 or more years of packaging/engineering experience with 4+ years within the Pharma/Bio industry\nDemonstrated Competencies/Skills:\n- Independent thinker with demonstrated skills working in teams or leading\nproject teams\n- Strong Interpersonal and communication skills", "date_new": "2012-04-04 03:02:42", "url": "http://www.amgen.jobs/xml/27630449/job", "country": "United States", "company": "Amgen", "title": "Sr Packaging Engineer", "reqid": "14574BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 27630449}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 14249BR\nJob Posting Title Sr Project Manager - Manufacturing of the Future (MoF) Engineering\nCareer Category Project Management\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description The MoF Engineering Project Manager is responsible for coordinating elements of MoF engineering design and leading multiple MoF engineering work streams. The engineer shall provide direction to the operations team on the engineering elements needed to ensure all projects and facilities under the MoF program become qualified and operational within specified timeframe and budgets.\n\nThis role will require up to 50% travel and is located in Thousand Oaks, CA.\n\nKey responsibilities include, but are not limited to, the following:\n\nTechnical / Design Leadership: Provide leadership to align technical issues across all MoF capital projects and interface with the equipment team leads. Ensure projects align with Amgen\u2019s technical business processes.\n\nPlanning: Interface with equipment and project teams to ensure there is alignment of key program milestones and articulate the impact of changes in projects or program on the individual schedules. Develop specific action plans with deliverables and resources needed to deliver elements such as program maintenance of the new facility and equipment, all Maximo elements, calibration, etc.\n\nConstruction: Oversight of technical issues that arise during construction, ability to understand programmatic aspects of decisions made and skills to understand when necessary to escalate issues to the leadership.\n\nCommissioning: Ensure proper commissioning programs are developed and used, and qualification processes are implemented.\n\nMaintenance: Develop maintenance program with operations team, interfacing with project teams, leadership team, Engineering Technical Authority, and receiving site. Monitoring progress, resolving technical conflicts.\nBasic Qualifications Doctorate degree and 2 years of directly related experience\nOR\nMaster\u2019s degree and 6 years of directly related experience\nOR\nBachelor\u2019s degree and 8 years of directly related experience\nOR\nAssociate\u2019s degree and 10 years of directly related experience\nOR\nHigh school diploma / GED and 12 years of directly related experience\nPreferred Qualifications \u2022 Background in drug substance manufacturing facilities, well rounded experience in design, project engineering, process engineering, qualification, and maintenance\n\u2022 Masters Degree in Engineering, Chemical, BioChemical, Mechanical\n\u2022 Professional registration, such as a Professional Engineer license\n\u2022 10 years engineering experience in a site and/or corporate engineering environment, with specific specialized expertise in Upstream Processes, Downstream Processes, and CIP/SIP including 5 years experience in executing engineering projects (cross functional team managing departmental or functional level projects: approving resources, assigning tasks, presenting milestones, deciding cost/benefit analysis)\n\u2022 5 years experience in engineering in biotech/pharmaceutical industry in manufacturing support (quality, process development, manufacturing, clinical manufacturing)\n\u2022 Strong communication, relationship building, leadership and mentoring skills\n\u2022 Proven ability to manage and deliver results in a highly fluid, interactive matrix environment", "date_new": "2012-03-08 19:15:41", "url": "http://www.amgen.jobs/xml/27012351/job", "country": "United States", "company": "Amgen", "title": "Sr Project Manager - Manufacturing of the Future (MoF) Engineering", "reqid": "14249BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 27012351}, {"country_short": "IRL", "city": "Dublin", "description": "Auto req 14042BR\nJob Posting Title Sr Engineer - Packaging (Line Owner)\nCareer Category Engineering\nEmployee Subgroup Salaried FT\nCountry (State/Region) Ireland\nLocation (City) Dublin\nDun Laoghaire\nAmgen Job Description Sr. Engineer \u2013 Packaging\n(Line Owner)\nLevel 5\nAmgen Dun Laoghaire - Dublin\n\nOverview:\n\nThis position will be part of the packaging group and be responsible for the execution of all projects in that area. The Sr. Engineer reports to the Sr. Manager Manufacturing \u2013Packaging. The candidate will have knowledge and proficiency in the use of statistical analysis tools, continuous improvement methodologies, problem solving and applied engineering relating to packaging equipment and associated automation systems.\nResponsibilities include:\n\nThe chosen candidate would typically be involved in activities such as (but not exclusively);\n\n\u2022 Monitoring of day to day manufacturing operations.\n\u2022 Data trend analysis for all performance aspects of a packaging line.\n\u2022 The definition and scoping of all process improvement activities relating to the area.\n\u2022 Solving or escalating problems as appropriate.\n\u2022 All design reviews associated with equipment purchases.\n\u2022 Troubleshooting performance trends.\n\u2022 Risk assessments and mitigation projects relating to line performance.\n\u2022 Support of new product introductions and supporting introduction of new equipment.\n\u2022 The development and execution of FAT, SAT and IOQ protocols in Ireland and abroad.\n\u2022 Representing manufacturing on site based teams involved in implementing new technology, products or business processes to the site.\n\u2022 Continuous improvement programs and all performance improvement projects.\n\u2022 Review and approval of changes to operating procedures and the change control process relating to the line.\n\u2022 Designing, executing, implementing and directing engineering or process projects which significantly contribute to attaining high priority goals.\n\u2022 Works in a collaborative manner within the Process Teams structure and contributes to investigations, Cross Functional teams within the organization etc.\n\u2022 Supporting non conformance investigation.\nBasic Qualifications Basic Qualifications:\n\n\u2022 Bachelors degree in Engineering (Mechanical, Electrical or Chemical)\n\u2022 Senior level experience providing solutions and support in the biotechnology or pharmaceutical industries.\n\u2022 Demonstrated leadership skills with the ability to build teams and operate across functional boundaries, both internal and external.\n\u2022 Significant relevant industrial project experience\nPreferred Qualifications Preferred Experience\n\u2022 Typically 8+ years engineering experience in an aseptic pharmaceutical environment\n\u2022 Significant experience large project related activities including GMP qualification experience.", "date_new": "2012-03-07 02:05:14", "url": "http://www.amgen.jobs/xml/26971791/job", "country": "Ireland", "company": "Amgen", "title": "Sr Engineer - Packaging (Line Owner)", "reqid": "14042BR", "state": null, "state_short": null, "location": "Dublin, IRL", "uid": 26971791}, {"country_short": "IRL", "city": "Dublin", "description": "Auto req 14211BR\nJob Posting Title 2 x Sr Associate Tech Engineering - Syringe\nCareer Category Engineering\nEmployee Subgroup Salaried FT\nCountry (State/Region) Ireland\nLocation (City) Dublin\nDun Laoghaire\nAmgen Job Description Sr. Associate Tech Engineer - Syringe\n\nAmgen Dun Laoghaire - Dublin\n\nOverview:\n\nThe Sr. Associate Tech Engineer operates as part of a process team. This position will initially be part of the team responsible for the commissioning, qualification and start up of Amgen\u2019s new syringe manufacturing facility. On completion of the start up, this position will transition to providing technical support to the manufacturing facility.\n\nKey Responsibilities:\n\nDuring start up the individual will execute all project activities associated with start up of the syringe line, including but not limited to:\n\u2022 Participation in equipment design reviews.\n\u2022 Development and execution of FAT, SAT, IOQ protocols.\n\u2022 Development, revision and review of technical documents such as SOP\u2019s, job plans etc.\n\u2022 A willingness to spend time abroad over the next 2 years.\n\u2022 Ensuring that work is completed in a safe manner under GMP conditions and in accordance with applicable Amgen procedures.\n\nDuring routine manufacturing operations, the individual will provide technical support to the syringe line by:\n\u2022 Ensuring that daily output and compliance requirements are met.\n\u2022 Tracking equipment and process performance to ensure compliance with operating standards.\n\u2022 Implementing corrective actions when deviations from standard are detected.\n\u2022 Ensuring that maintenance personnel have clear definition/guidance when equipment problems are encountered and improvement is required.\n\u2022 Working to investigate, resolve and closeout all issues relating to NC\u2019s, CAPA\u2019s, process deviations.\n\u2022 Owning manufacturing area SOP\u2019s and change control reports.\nBasic Qualifications Basic Qualifications:\n\n\u2022 Degree in Engineering/Science or equivalent\n\u2022 Significant relevant process engineering industry experience\n\nKey competencies:\n\n\u2022 Analytical thinking\n\u2022 Focus on quality\n\u2022 Drive for results\n\u2022 Initiative\n\u2022 Planning and prioritisation\n\u2022 Teamwork and Co-operation\nPreferred Qualifications Preferred Qualifications.\n\u2022 Excellent written and verbal communication skills\n\u2022 Knowledge of applicable Regulatory requirements\n\u2022 Experience with Regulatory inspections desirable\n\u2022 Experience leading cross-functional teams desirable\n\u2022 Experience working with teams and influencing decisions", "date_new": "2012-03-07 02:04:45", "url": "http://www.amgen.jobs/xml/26971668/job", "country": "Ireland", "company": "Amgen", "title": "2 x Sr Associate Tech Engineering - Syringe", "reqid": "14211BR", "state": null, "state_short": null, "location": "Dublin, IRL", "uid": 26971668}, {"country_short": "IRL", "city": "Dublin", "description": "Auto req 13867BR\nJob Posting Title Sr Packaging Validation Engineer\nCareer Category Engineering\nEmployee Subgroup Salaried FT\nCountry (State/Region) Ireland\nLocation (City) Dublin\nDun Laoghaire\nAmgen Job Description Job Title Senior Packaging Validation Engineer\n\nJob Description Senior Packaging Validation Engineer\n\nAs a senior Packaging validation engineer, you will be responsible Leading a Cross Functional Team to ensure that the Validation Activities associated with the Packaging and Labelling and Shipping of Sterile Filled Syringes and Vials are in compliance with Division Quality System requirements and recognised international standards.\n\nMajor Responsibilities\n\n\u2022 Development of Validation Plans, Installation Verification, Functional Testing and Performance Qualifications (PQs) for Vial and Syringe Packaging for a large scale packaging operations.\n\u2022 Leading the team to ensure all aspects of activity within the Packaging Validation adhere to required policies and procedures, including safety and training.\n\u2022 Ensure that the Site meets the quality requirements of its customers and applicable regulations FDA, EU & International Standards.\n\u2022 Be involved in all Validation Cross Functional Teams (CFTs) at the site to ensure adherence to required policies and procedures.\n\u2022 Pre-approve and post-approve validation protocols and assessments from a quality system documentation perspective.\n\u2022 Liaise with Engineering and external vendors regarding equipment User Requirement Specifications (URS\u2019s), Factory Acceptance Tests (Fat\u2019s) to ensure the QBD principles are being followed.\n\u2022 Assist in the development of any existing Validation program to ensure continued compliance to the necessary regulations. Input to Site Validation Guidance Documents\n\u2022 Collate and report on relevant Validation data/matrices.\n\u2022 Assist in deviation and exception resolution and root cause analysis.\n\u2022 Develop and rollout Validation Training for the site on subjects assigned by the Site Validation Leader.\n\u2022 Participate as required in project activities.\n\u2022 Ensure all relevant employees are aware of corporate and relevant International Standards and their implementation throughout the plant.\nBasic Qualifications Experience/Background\n\n\u2022 A third level qualification in Science, Engineering or a relevant Quality discipline.\n\u2022 Minimum 5-10 years experience in a similar role.\nPreferred Qualifications Overall knowledge in equipment, facility, cleaning and steaming validation. Technical understanding of pharmaceutical/biotechnology unit operations. Project management skills Skilled at initiation and leading cross functional teams Database and spreadsheet application skills Strong technical writing and oral communication skills Facilitation and presentation skills Experience with leading complex investigations and CAPAs Ability to evaluate compliance issues and interact with regulatory inspectors", "date_new": "2012-02-13 19:29:10", "url": "http://www.amgen.jobs/xml/26495601/job", "country": "Ireland", "company": "Amgen", "title": "Sr Packaging Validation Engineer", "reqid": "13867BR", "state": null, "state_short": null, "location": "Dublin, IRL", "uid": 26495601}, {"country_short": "USA", "city": "Boulder", "description": "Auto req 13823BR\nJob Posting Title Sr Engineer - Mfg Projects\nCareer Category Operations\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - Colorado\nLocation (City) Boulder\nAmgen Job Description Amgen Colorado\u2019s Engineering team is responsible for delivering capital and expense improvement projects to our client\u2019s business needs. We target small to moderate sized projects located within operating business units. We feature staff with diverse engineering backgrounds with intimate knowledge of operations and working in GMP environments. We minimize impact to client operations due to excellent planning, coordination, and controls.\n\nThe Sr. Engineer is responsible for engineering design, implementation, construction support, technical execution and commissioning for multiple capital and expense projects at Amgen Colorado. This involves preparation of engineering studies, conceptual design alternatives, schematic and design details, and commissioning protocols.\n\n\u2022 Supports the project team during engineering studies geared toward developing the technical and business justification for engineering projects.\n\u2022 Work with clients and stakeholders from manufacturing, process development, facilities, quality assurance and validation to develop and define user requirements.\n\u2022 Responsible for identifying and refining design alternatives during conceptual schematic design evaluations.\n\u2022 Responsible for executing and/or directing, coordinating and supervising the work of consultants and engineering firms during the schematic and detailed design phases.\n\u2022 Executes and/or directs technical resources during the implementation phase (includes construction, startup, commissioning, and validation).\n\u2022 Responsible for turnover packages prepared during the detailed design phase and project close out.\n\u2022 Responsible in ensuring that all Amgen standards and procedures are followed by the project team.\n\u2022 Verifies that all change control procedures are properly documented.\n\u2022 Works closely with other discipline and/or project engineers to coordinate the design and implementation.\n\u2022 May work in as a discipline or project engineer depending on the needs of each project.\nBasic Qualifications \u2022 Doctorate degree\nOR\n\u2022 Master\u2019s degree & 3 years of directly related experience\nOR\n\u2022 Bachelor\u2019s degree & 5 years of directly related experience\nOR\n\u2022 Associate\u2019s degree & 10 years of directly related experience\nOR\n\u2022 High school diploma / GED & 12 years of directly related experience\nPreferred Qualifications Bachelor degree in Engineering and 8+ years of related engineering experience with four of those years engaged in projects in a manufacturing environment.\n\nDemonstrated understanding of project life cycle, versatility, adaptability, decision making skills, collaboration, accountability, problem solving skills, teamwork, and quality control on engineering projects. Position requires excellent technical writing and verbal communication skills.\n\nDemonstrated track record of being science-based, competing intensely and winning, creating value for patients, staff and stockholders, being ethical, trusting and respecting each other, working in teams, ensuring quality, and collaborating, communicating, and being accountable.\n\n? Experience with design and implementation in a manufacturing environment, and with validation and change control methodology strongly desired.\n? Knowledge and skills in Microbial and Mammalian Fermentation, Cell Culture and Purification systems strongly desired.\n? Demonstrated leadership experience\n? Project management experience\n? Technology transfer experience\n? Knowledge of cGMP pharmaceutical manufacturing process design requirements.\n? High level experience with design, programming, and commissioning activities for all automation/process systems and controllers (such as SLC, PLC, DeltaV, BMS, HMI & SCADA).\n?  Ability to review and approve engineering documentation such as requirements and design documents, I/O diagrams, one-line diagrams, panel layout diagrams, system architecture diagrams, and instrument data sheets.", "date_new": "2012-02-10 18:16:30", "url": "http://www.amgen.jobs/xml/26456571/job", "country": "United States", "company": "Amgen", "title": "Sr Engineer - Mfg Projects", "reqid": "13823BR", "state": "Colorado", "state_short": "CO", "location": "Boulder, CO", "uid": 26456571}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 12623BR\nJob Posting Title Sr Engineer - Facilities/Utilities\nCareer Category Operations\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description \u2022 As a member of the Clinical Bulk Facilities & Engineering organization, this position serves as the plant engineer and system owner for facility/utility systems and equipment in a bulk biopharmaceutical manufacturing facility. Responsibilities include providing operational support, troubleshooting, and optimization for assigned equipment; directing and coordinating equipment maintenance to improve reliability; and applying advanced engineering principles to the design and implementation of new equipment.\n\u2022 Support system reliability and operational optimization efforts. Identify system performance risks (e.g. single point of failure or obsolescence) and implement risk reduction strategies. Lead and execute improvement efforts (including identifying cycle reduction time opportunities, efficiency gains, and yield enhancement opportunities).\n\u2022 Lead technical root cause analysis, incident investigations, and troubleshooting on equipment (mechanical, electrical, instrumentation and control system problems). Previous formal training and/or demonstrated experience is preferred.\n\u2022 Analyze problems, develop and propose engineering solutions in a scientific manner using data-driven techniques and analyses (e.g. Statistical Process Control, Six Sigma, predictive maintenance analysis, etc.)\n\u2022 Support new product introductions or new technology introductions by performing engineering assessments, implementing equipment modifications, and supporting engineering runs.\n\u2022 Responsibilities will include support of capital projects. This role involves the application of advanced process engineering principles in the design, specification, construction, startup, and validation of process equipment and systems for capital projects of significant scope and complexity. Demonstrated understanding of project life cycles is preferred. Candidate should be familiar with engineering processes from initial conceptualization through project turnover to operations.\n\u2022 Ensures the logical, systematic translation of design requirements and constraints into process equipment/system solutions. Assists with project definition by performing engineering studies and assessments for process equipment systems, clean utilities, and production facility improvements.\n\u2022 Desired skills include demonstrated ability to translate production processes and user requirements into detailed designs aligned with industry practices; ability to apply knowledge of engineering principles and practices outside of discipline expertise to a broad variety of assignments in related fields; and ability to employ advanced techniques within area of engineering expertise.\n\u2022 Support a safe working environment by complying with all pertinent environmental health/safety practice, rules and regulations.\nBasic Qualifications Doctorate degree\nOR\nMaster\u2019s degree & 3 years of experience directly related to the job\nOR\nBachelor\u2019s degree & 5 years of experience directly related to the job\nOR\nAssociate\u2019s degree & 10 years of experience directly related to the job\nOR\nHigh school diploma / GED & 12 years of experience directly related to the job\nPreferred Qualifications \u2022 Bachelor\u2019s degree in Chemical Engineering or Mechanical preferred\n\u2022 6+ years of relevant work experience with 5+ years experience in operations/manufacturing environment\n\u2022 Direct experience with regulated environments (e.g. cGMP, OSHA, EPA, etc.) is critical. Detailed understanding of industry regulations and ability to interpret in establishing current practices.\n\u2022 Hands-on experience with manufacturing process equipment including advanced troubleshooting, reliability and performance improvements, and design optimization.\n\u2022 Ability to apply advanced engineering principles to the design and implementation of system modifications, introduction of new processes, and execution of capital projects. Develop technical solutions to complex problems requiring the regular use of ingenuity and creativity.\n\u2022 Strong leadership, technical writing, and communication/presentation skills are required.\n\u2022 Work schedule flexibility as required to support 24/7 operations, requiring occasional after-hours engineering coverage.\n\u2022 Direct experience in equipment engineering and troubleshooting with compendial water systems (ie. Water for Injection, Purified Water, and Clean Steam), plant utility systems (eg. clean gases, chilled water, plant steam), and clean room HVAC systems.\n\u2022 Working knowledge and experience with cGMP procedures and engineering practices on pharmaceutical/biotech production processes, facilities, and equipment. Candidate should be experienced in change control, nonconformances, corrective and preventative actions, and validation practices.\n\u2022 Experience in design and startup engineering directly related to bulk biopharmaceutical production including facility design, procurement, construction, startup, and validation is preferred. Equipment acquisition and design engineering experience is desired.\n\u2022 Must be independent, self-motivated, organized, able to multi-task in project environments, and skilled in communication, facilitation, and collaboration. Individual must be a team player prepared to work in and embrace a team-based culture that relies on collaboration for effective decision-making.", "date_new": "2011-11-01 22:17:20", "url": "http://www.amgen.jobs/xml/24526977/job", "country": "United States", "company": "Amgen", "title": "Sr Engineer - Facilities/Utilities", "reqid": "12623BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 24526977}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 12624BR\nJob Posting Title Sr Engineer - Process Equipment\nCareer Category Operations\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description \u2022 As a member of the Clinical Bulk Facilities & Engineering organization, this position serves as a project/plant engineer for facility systems and process equipment in a bulk biopharmaceutical manufacturing facility. Responsibilities include applying advanced engineering principles to the design and implementation of new equipment; providing operational support, troubleshooting, and optimization of assigned manufacturing process equipment; and directing and coordinating equipment maintenance to improve reliability.\n\u2022 This position serves as a lead or discipline engineer for capital projects. This role involves the application of advanced process engineering principles in the design, specification, construction, startup, and validation of process equipment and systems for capital projects of significant scope and complexity. Demonstrated understanding of project life cycles is preferred. Candidate should understand engineering processes from initial conceptualization through project turnover to operations.\n\u2022 Ensures the logical, systematic translation of design requirements and constraints into process equipment/system solutions. Assists with project definition by performing engineering studies and assessments for process equipment systems, clean utilities, and production facility improvements.\n\u2022 Desired skills include demonstrated ability to translate production processes and user requirements into detailed designs aligned with industry practices; ability to apply knowledge of engineering principles and practices outside of discipline expertise to a broad variety of assignments in related fields; and ability to employ advanced techniques within area of engineering expertise.\n\u2022 Support a safe working environment by complying with all pertinent environmental health/safety practice, rules and regulations.\n\u2022 Supports system reliability and operational optimization efforts. Identify system performance risks (e.g. single point of failure or obsolescence) and implement risk reduction strategies. Lead and execute improvement efforts (including identifying cycle reduction time opportunities, efficiency gains, and yield enhancement opportunities).\n\u2022 Lead technical root cause analysis, incident investigations, and troubleshooting on equipment (mechanical, electrical, instrumentation and control system problems). Previous formal training and/or demonstrated experience is preferred.\n\u2022 Analyze problems, develop and propose engineering solutions in a scientific manner using data-driven techniques and analyses (e.g. Statistical Process Control, Six Sigma, predictive maintenance analysis, etc.)\n\u2022 Support new product introductions or new technology introductions by performing engineering assessments, implementing equipment modifications, and supporting engineering runs.\nBasic Qualifications Doctorate degree\nOR\nMaster\u2019s degree & 3 years of experience directly related to the job\nOR\nBachelor\u2019s degree & 5 years of experience directly related to the job\nOR\nAssociate\u2019s degree & 10 years of experience directly related to the job\nOR\nHigh school diploma / GED & 12 years of experience directly related to the job\nPreferred Qualifications \u2022 Master\u2019s degree in Chemical Engineering or Bioengineering preferred\n\u2022 8+ years of relevant work experience with 7+ years experience in operations/manufacturing environment\n\u2022 Direct experience with regulated environments (e.g. cGMP, OSHA, EPA, etc.) is critical. Detailed understanding of industry regulations and ability to interpret in establishing current practices.\n\u2022 Direct experience in equipment engineering and troubleshooting with fermentors, bioreactors, centrifuges, chromatography columns and systems, and/or ultrafiltration/diafiltration systems.\n\u2022 Hands-on experience with manufacturing process equipment including advanced troubleshooting, reliability and performance improvements, and design optimization.\n\u2022 Ability to apply advanced and diverse engineering principles to the design and implementation of major system modifications, introduction of new processes, and capital projects. Develop technical solutions to complex problems requiring the regular use of ingenuity and creativity.\n\u2022 Strong leadership, technical writing, and communication/presentation skills are required.\n\u2022 Work schedule flexibility as required to support 24/7 operations, requiring occasional after-hours engineering coverage.\n\u2022 Working knowledge and experience with cGMP procedures and engineering practices on pharmaceutical/biotech production processes, facilities, and equipment. Candidate should be experienced in change control, nonconformances, corrective and preventative actions, and validation practices.\n\u2022 Experience in design and startup engineering directly related to bulk biopharmaceutical production including process equipment and facilities design, procurement, construction, startup, and validation is preferred. Equipment acquisition and design engineering experience is desired.\n\u2022 Must be independent, self-motivated, organized, able to multi-task in project environments, and skilled in communication, facilitation, and collaboration. Individual must be a team player prepared to work in and embrace a team-based culture that relies on collaboration for effective decision-making.", "date_new": "2011-11-01 22:17:12", "url": "http://www.amgen.jobs/xml/24526976/job", "country": "United States", "company": "Amgen", "title": "Sr Engineer - Process Equipment", "reqid": "12624BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 24526976}]