Amgen Hiring for Sr Engineer at Thousand Oaks, CA Full Time

Engineering

• Identify, support, and/or lead implementation of engineering based improvements or upgrades to the equipment or facility systems. This may include development of business case for improvement and identification of design requirements and then translation of requirements into process equipment/system design, specification and supporting the construction, startup, and validation of equipment.
• Directing and coordinating equipment maintenance as necessary to ensure systems are in proper working order
• Ensure necessary commissioning and qualification of systems is completed and interact with inspectors
• Develop metrics-based performance focused on the maintenance systems effectiveness and operating level performance.
• Providing troubleshooting support to reduce production downtime. This will involve leading and/or supporting technical root cause analysis and implementation of corrective/preventive action
• Support new product/technology introductions by performing engineering assessments, implementing equipment modifications, identifying spare parts, job plan development and supporting engineering runs.
• Ensure systems are installed and operating safety and align with pertinent environmental health/safety practice, rules and regulations
• Responsible for determining appropriate CAPAs, action plan development, QMTS data entry, owns the record, initiate child CAPA’s and CAPA EVs, timely closure and responses, provision of technical data and s.
• Use tools and techniques of continuous improvement wherever possible. Establish equipment monitoring parameters and control limits. Routinely provide updates on metrics. Provide 2nd tier trouble shooting to support ops and maintenance groups as follow on from tier 1 initial problem solving. Change over reduction projects. Failure trending
• Up to 10% domestic travel

• Bachelor’s degree in Chemical or Mechanical Engineering
• 6+ years’ of relevant work experience with 5+ years’ experience in Biopharmaceutical operations/manufacturing environment
• Experience working in a regulated environment (e.g. cGMP, OSHA, EPA, etc.) and familiarity with GMP quality systems/processes such as change control, non-conformances, corrective and preventative actions, and qualifications/validation
• Direct knowledge of design and troubleshooting with GMP Biopharmaceutical Production facility equipment/systems such as cell culture reactors, chromatography, filtration, filling, lyophilization, inspection, device assembly, as well as other equipment needed to support these processes such as autoclaves, clean in place (CIP) systems, washers, clean steam, water for injection, etc.
• Ability to analyze problems, develop and propose engineering solutions in a scientific manner using data-driven techniques and analyses (e.g., Root Cause Analysis (RCA), Statistical Process Control (SPC), Six Sigma, Predictive Maintenance, etc.)
• Experience applying engineering principles to the design and implementation of system modifications, introduction of new processes, and execution of capital projects
• Understanding of the execution process of capital projects in a GMP Biopharmaceutical Production facility including procurement, construction, startup, and validation
• Understanding of safety requirements working in a GMP Biopharmaceutical Production facility.
• Independent, self-motivated, organized, able to multi-task in project environments, and skilled in communication, facilitation, and collaboration
• Team player prepared to work in and embrace a team based culture that relies on collaboration for effective decision-making
• Strong leadership, technical writing, and communication/presentation skills
• Work schedule flexibility to support 24/7 operations, requiring occasional after-hours engineering coverage as required from time to time

• Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans and bi-annual company-wide shutdowns
• Flexible work models, including remote work arrangements, where possible

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111,913.00 USD – 132,048.00 USD