Auto req 10415BR
Job Posting Title : Sr Engineer – Mfg Support
Career Category Manufacturing
Employee Subgroup Salaried FT
Country (State/Region) United States – California
Location (City) Thousand Oaks
Amgen Job Description As a member of the ATO GMP F&E Central Support Team, this position will provide mechanical systems discipline engineering and project engineering support across Amgen Clinical Operations. Clinical Operations facilities include bulk biopharmaceutical manufacturing, aseptic filling and packaging, Quality Labs, Small Molecule manufacturing pilot plant, and GMP Warehouse & Distribution facilities.
Specific Responsibilities are split between mechanical systems discipline engineering support and project engineering support:
Mechanical Systems Discipline Engineering Support
• Provide technical expertise and guidance on mechanical, electrical, and plumbing systems (MEP). Partner with Global Facilities Engineering group to coordinate additional MEP discipline support as required.
• Provide technical expertise for GMP HVAC, pressure cascade and HEPA filtration design.
• Lead or support technical root cause analysis, incident investigations, and troubleshooting on equipment (mechanical, electrical, instrumentation and control system problems).
• Lead or support equipment risk evaluation and mitigation efforts using established risk evaluation techniques (e.g., FMEA).
• 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.)
• Partner with Amgen’s engineering network including the Engineering Technical Authority (Corporate Engineering). Serve as an ATO GMP F&E site technical lead (local contact / subject matter expert) for area of discipline to escalate issues to the network or provide input on network level initiatives.
• Participate in the GMP F&E Engineering Continuous Improvement Team (ECIT) to identify and implement opportunities to improve engineering processes to achieve Operational Excellence.
Project Engineering Support
• Serve as the project technical lead accountable for overall planning and coordination of all engineering deliverables. Partner closely with Amgen Project Manager to develop project scope, schedule, and budget. Demonstrated ability to act as both Project Manager and Project Engineer for smaller projects is preferred.
• Partner with Amgen Project Manager to develop project justification / drivers and options analysis and present to management for funding approval.
• Apply systems engineering principles in the design, specification, construction, startup, and validation of mechanical equipment and systems for capital projects of moderate to high scope and complexity. Candidate should have previous exposure to project engineering processes from initial conceptualization through project turnover to operations.
• Ensure the logical, systematic translation of design requirements and constraints into mechanical equipment/system solutions. Assist with project definition by performing engineering studies and assessments for mechanical equipment systems, clean utilities, and production facility improvements.
• Understand and apply relevant industry practices, engineering codes and Amgen specifications and standards.
• Ensure compliance with Amgen’s engineering design standards and equipment acquisition process for all equipment acquisition or modifications.
• Support vendor RFP, bidding, and selection processes using standard tools (e.g. KT analysis) in partnership with Amgen Project Manager and sourcing representatives.
• Provide oversight and direction to contract architectural and engineering firms in the engineering study, design, execution, and commissioning phases of projects.
• Support a safe working environment by complying with all pertinent internal and external environmental health/safety practices and regulations.
Basic Qualifications • Doctorate degree
OR
• Master’s degree & 3 years of directly related experience
OR
• Bachelor’s degree & 5 years of directly related experience
OR
• Associate’s degree & 10 years of directly related experience
OR
• High school diploma / GED & 12 years of directly related experience
Preferred Qualifications • Bachelor’s degree in Mechanical Engineering preferred; other engineering disciplines with demonstration of relevant work experience.
• 6+ years of relevant work experience with 3+ years experience in operations / manufacturing environment.
• Direct experience with regulated environments (e.g. FDA, cGMP, OSHA, EPA, etc.) is critical.
• Hands-on experience with mechanical systems used in biopharmaceutical manufacturing including advanced troubleshooting and design optimization.
• Ability to apply advanced and diverse engineering principles to the design and implementation of major system modifications, introduction of new equipment, and capital projects. Develop technical solutions to complex problems requiring the regular use of ingenuity and creativity.
• 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.
• Must have ability to operate effectively in a cross-functional environment while managing competing priorities for multiple clients.
• 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.
To Apply:
https://sjobs.brassring.com/1033/asp/tg/cim_jobdetail.asp?SID=^fRkk0HvecD0s8KujesNHoGuu1XDRmNJqSuQ/6r2KyUWvzW9vfbnUKTVlITIm8dP9&jobId=789838&type=search&JobReqLang=1&recordstart=1&JobSiteId=5308&JobSiteInfo=789838_5308&GQId=0
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