Amgen Jobshttp://www.amgen.jobs2012-05-26 22:52:01.475034USAThousand 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/jobUSAWoburnAuto req 15596BR Job Posting Title Sr Validation Engineer Career Category Engineering Employee Subgroup Salaried FT Country (State/Region) United States - Massachusetts Location (City) Woburn Amgen 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. Key Responsibilities: • Assist with the administrative and execution of Validation plans and validation protocols for major projects on site (facility, manufacturing processes, equipment, cleaning, and software). • Assist with the validation activities for the expansion project. • Prepare and /or revise validation protocols/procedures as required. • Review and execute qualification and summary reports, write and revise as needed. • Participate in review of manufacturing operational SOPs and maintenance for facility and process. • Assist in troubleshooting, complex or usual problems arising from equipment/system failures. • Ensure continuous validation maintenance for facility and process through change control program. • Analyze validation data, prepare reports, and make recommendations for changes and or/improvements. • Represent department in meetings when required. Other Responsibilities: • Coordinate generation and completion of any deviations, equipment and document change control resulting from a qualification and /or validation activity. • Assist in defining and implementing acceptance criteria, specifications, and standards for each qualification activity. • Interface with manufacturing, technical operation and QC group. Basic Qualifications Doctorate degree OR Master’s degree and 3 years of directly related experience OR Bachelor’s degree and 5 years of directly related experience OR Associate’s degree and 10 years of directly related experience OR High school diploma / GED and 12 years of directly related experience Preferred Qualifications Educational Requirements: Minimum of a BS in Engineering or related technical discipline. Experience and Skill Requirements: • 6-8+ years experience in the validation of biotechnology or pharmaceutical equipment and processes. • Technical understanding of pharmaceutical/biotechnology unit operations. • Strong communication and interpersonal skills • Good knowledge of cGMP requirements and current industry practices • Demonstrate ability to work in a cross-functional team environment • The ideal candidate will possess excellent planning and coordination skills and be able to readily adapt to changes in priorities and project schedules.2012-05-09 20:34:40United StatesAmgenMassachusetts15596BRMAWoburn, MA28581296http://www.amgen.jobs/xml/28581296/jobUSAThousand OaksAuto req 15524BR Job Posting Title Engineering Projects Sr Mgr (IS Project Controls) Career Category Engineering Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen 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’s 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. The 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. The 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. Functions (Duties/Accountabilities): 1. Assist the Project Manager(s) in developing project strategies 2. Assist in the preparation of Amgen project funding documents 3. 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. 4. . Reviewing and analyzing Construction, IS and Automation engineers, vendors and contractor bids 5. Evaluate Construction, IS and Automation engineers, vendors and contractors physical progress 6. Develop and monitor project schedules and cash flow 7. Develop Construction, IS and Automation engineering, vendors and construction cost forecasts for remaining work 8. Reviewing, approving Construction, IS and Automation engineers, vendors and contractor buy outs, change orders and invoices 9. Administrating the closeout of contracts and purchase orders. 10.Prepare monthly project status reports for senior management 11 Lead risk analysis reviews for cost estimates, cost forecasts and schedules using applicable software packages. 12. Project controls resource planning for IS 13. Development of common project control standards to be used in IS 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 • Bachelors Degree in Engineering, Technology or Life Sciences • 8 + years of experience in commercial and/or industrial construction in project controls: i.e. cost control, scheduling and estimating • 5 + years in biotechnology/pharmaceutical industries • Experience in IS systems supporting global/multiple sites • Proficiency in using SAP, CPM Scheduling and @ Risk software • Proven ability to manage and deliver results in a highly fluid, interactive matrix environment • 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 • Lean Construction, Six Sigma certifications and/or other continuous improvement methods2012-05-08 18:40:38United StatesAmgenCalifornia15524BRCAThousand Oaks, CA28541246http://www.amgen.jobs/xml/28541246/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 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 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 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 14249BR Job Posting Title Sr Project Manager - Manufacturing of the Future (MoF) Engineering Career Category Project Management Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen 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. This role will require up to 50% travel and is located in Thousand Oaks, CA. Key responsibilities include, but are not limited to, the following: Technical / 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’s technical business processes. Planning: 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. Construction: 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. Commissioning: Ensure proper commissioning programs are developed and used, and qualification processes are implemented. Maintenance: Develop maintenance program with operations team, interfacing with project teams, leadership team, Engineering Technical Authority, and receiving site. Monitoring progress, resolving technical conflicts. Basic Qualifications Doctorate degree and 2 years of directly related experience OR Master’s degree and 6 years of directly related experience OR Bachelor’s degree and 8 years of directly related experience OR Associate’s degree and 10 years of directly related experience OR High school diploma / GED and 12 years of directly related experience Preferred Qualifications • Background in drug substance manufacturing facilities, well rounded experience in design, project engineering, process engineering, qualification, and maintenance • Masters Degree in Engineering, Chemical, BioChemical, Mechanical • Professional registration, such as a Professional Engineer license • 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) • 5 years experience in engineering in biotech/pharmaceutical industry in manufacturing support (quality, process development, manufacturing, clinical manufacturing) • Strong communication, relationship building, leadership and mentoring skills • Proven ability to manage and deliver results in a highly fluid, interactive matrix environment2012-03-08 19:15:41United StatesAmgenCalifornia14249BRCAThousand Oaks, CA27012351http://www.amgen.jobs/xml/27012351/jobIRLDublinAuto req 14042BR Job Posting Title Sr Engineer - Packaging (Line Owner) Career Category Engineering Employee Subgroup Salaried FT Country (State/Region) Ireland Location (City) Dublin Dun Laoghaire Amgen Job Description Sr. Engineer – Packaging (Line Owner) Level 5 Amgen Dun Laoghaire - Dublin Overview: This 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 –Packaging. 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. Responsibilities include: The chosen candidate would typically be involved in activities such as (but not exclusively); • Monitoring of day to day manufacturing operations. • Data trend analysis for all performance aspects of a packaging line. • The definition and scoping of all process improvement activities relating to the area. • Solving or escalating problems as appropriate. • All design reviews associated with equipment purchases. • Troubleshooting performance trends. • Risk assessments and mitigation projects relating to line performance. • Support of new product introductions and supporting introduction of new equipment. • The development and execution of FAT, SAT and IOQ protocols in Ireland and abroad. • Representing manufacturing on site based teams involved in implementing new technology, products or business processes to the site. • Continuous improvement programs and all performance improvement projects. • Review and approval of changes to operating procedures and the change control process relating to the line. • Designing, executing, implementing and directing engineering or process projects which significantly contribute to attaining high priority goals. • Works in a collaborative manner within the Process Teams structure and contributes to investigations, Cross Functional teams within the organization etc. • Supporting non conformance investigation. Basic Qualifications Basic Qualifications: • Bachelors degree in Engineering (Mechanical, Electrical or Chemical) • Senior level experience providing solutions and support in the biotechnology or pharmaceutical industries. • Demonstrated leadership skills with the ability to build teams and operate across functional boundaries, both internal and external. • Significant relevant industrial project experience Preferred Qualifications Preferred Experience • Typically 8+ years engineering experience in an aseptic pharmaceutical environment • Significant experience large project related activities including GMP qualification experience.2012-03-07 02:05:14IrelandAmgenNone14042BRNoneDublin, IRL26971791http://www.amgen.jobs/xml/26971791/jobIRLDublinAuto req 14211BR Job Posting Title 2 x Sr Associate Tech Engineering - Syringe Career Category Engineering Employee Subgroup Salaried FT Country (State/Region) Ireland Location (City) Dublin Dun Laoghaire Amgen Job Description Sr. Associate Tech Engineer - Syringe Amgen Dun Laoghaire - Dublin Overview: The 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’s new syringe manufacturing facility. On completion of the start up, this position will transition to providing technical support to the manufacturing facility. Key Responsibilities: During start up the individual will execute all project activities associated with start up of the syringe line, including but not limited to: • Participation in equipment design reviews. • Development and execution of FAT, SAT, IOQ protocols. • Development, revision and review of technical documents such as SOP’s, job plans etc. • A willingness to spend time abroad over the next 2 years. • Ensuring that work is completed in a safe manner under GMP conditions and in accordance with applicable Amgen procedures. During routine manufacturing operations, the individual will provide technical support to the syringe line by: • Ensuring that daily output and compliance requirements are met. • Tracking equipment and process performance to ensure compliance with operating standards. • Implementing corrective actions when deviations from standard are detected. • Ensuring that maintenance personnel have clear definition/guidance when equipment problems are encountered and improvement is required. • Working to investigate, resolve and closeout all issues relating to NC’s, CAPA’s, process deviations. • Owning manufacturing area SOP’s and change control reports. Basic Qualifications Basic Qualifications: • Degree in Engineering/Science or equivalent • Significant relevant process engineering industry experience Key competencies: • Analytical thinking • Focus on quality • Drive for results • Initiative • Planning and prioritisation • Teamwork and Co-operation Preferred Qualifications Preferred Qualifications. • Excellent written and verbal communication skills • Knowledge of applicable Regulatory requirements • Experience with Regulatory inspections desirable • Experience leading cross-functional teams desirable • Experience working with teams and influencing decisions2012-03-07 02:04:45IrelandAmgenNone14211BRNoneDublin, IRL26971668http://www.amgen.jobs/xml/26971668/jobIRLDublinAuto req 13867BR Job Posting Title Sr Packaging Validation Engineer Career Category Engineering Employee Subgroup Salaried FT Country (State/Region) Ireland Location (City) Dublin Dun Laoghaire Amgen Job Description Job Title Senior Packaging Validation Engineer Job Description Senior Packaging Validation Engineer As 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. Major Responsibilities • Development of Validation Plans, Installation Verification, Functional Testing and Performance Qualifications (PQs) for Vial and Syringe Packaging for a large scale packaging operations. • Leading the team to ensure all aspects of activity within the Packaging Validation adhere to required policies and procedures, including safety and training. • Ensure that the Site meets the quality requirements of its customers and applicable regulations FDA, EU & International Standards. • Be involved in all Validation Cross Functional Teams (CFTs) at the site to ensure adherence to required policies and procedures. • Pre-approve and post-approve validation protocols and assessments from a quality system documentation perspective. • Liaise with Engineering and external vendors regarding equipment User Requirement Specifications (URS’s), Factory Acceptance Tests (Fat’s) to ensure the QBD principles are being followed. • Assist in the development of any existing Validation program to ensure continued compliance to the necessary regulations. Input to Site Validation Guidance Documents • Collate and report on relevant Validation data/matrices. • Assist in deviation and exception resolution and root cause analysis. • Develop and rollout Validation Training for the site on subjects assigned by the Site Validation Leader. • Participate as required in project activities. • Ensure all relevant employees are aware of corporate and relevant International Standards and their implementation throughout the plant. Basic Qualifications Experience/Background • A third level qualification in Science, Engineering or a relevant Quality discipline. • Minimum 5-10 years experience in a similar role. Preferred 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 inspectors2012-02-13 19:29:10IrelandAmgenNone13867BRNoneDublin, IRL26495601http://www.amgen.jobs/xml/26495601/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/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/job