
Posted a month ago
Senior Manager Process Engineering
Amgen
Requirements
Degree in Engineering (Chemical or Mechanical preferred), Experience in biopharmaceutical manufacturing, People management experience, Knowledge of Upstream and Downstream purification, Experience with Commissioning and Qualification
Skills
Process EngineeringBiotechnologyGMP
About the role
Responsibilities
- Oversee the engineering team and lead technical projects to drive innovation in product design and manufacturing processes
- Execute and guide the commissioning and qualification of process equipment in alignment with GMP requirements
- Provide system ownership for biologics manufacturing equipment, including Upstream (bioreactors, harvest) and Downstream (chromatography, viral filtration, UFDF)
- Lead a team of Process Engineering professionals, establishing clear expectations, priorities, and development opportunities
- Collaborate with Manufacturing, Quality, Process Development, and Maintenance to ensure 24/7 operational reliability
- Identify and implement engineering-based improvements, including developing business cases and translating requirements into system designs
- Manage equipment maintenance programs, spare parts availability, and technical troubleshooting
- Participate in the budgeting process, including cost forecasting and resource allocation
Requirements
- Bachelor’s degree and 8 years of engineering experience (or equivalent experience as outlined in basic qualifications)
- 2 years of managerial experience directly managing people or leading teams and projects
- Experience in biopharmaceutical manufacturing or a regulated environment (e.g., cGMP)
- Ability to support 24/7 operations, including occasional after-hours engineering coverage
Preferred Qualifications
- Bachelor’s degree in Chemical or Mechanical Engineering or a related technical field
- 8+ years of relevant work experience with 5+ years in biopharmaceutical operations/manufacturing
- Direct knowledge of Upstream and Downstream purification processes and CIP/SIP skids
- Experience with Tech Transfer, Process Design, and Commissioning & Qualification (C&Q)
- Strong technical writing, communication, and analytical skills to resolve complex engineering problems
About the Company
Amgen is a leading biotechnology company dedicated to serving patients living with serious illnesses. Since 1980, Amgen has pioneered advancements in oncology, inflammation, general medicine, and rare diseases. The company focuses on leveraging biologics manufacturing expertise and advanced human genetics to deliver innovative medicines that improve health outcomes worldwide.
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Amgen · Holly Springs
