Senior Process Engineer
Amgen Inc
Amgen seeks a Senior Process Engineer to join the Facilities & Engineering group at its advanced FleX Batch drug substance manufacturing facility in Holly Springs, North Carolina. The role involves designing, commissioning, and qualifying biopharmaceutical process equipment and systems, with focus on downstream process engineering and plant operational reliability.
Responsibilities
- Provide system ownership for biopharmaceutical process equipment and identify improvement opportunities
- Collaborate with manufacturing, quality, and process development teams to ensure reliable plant operations
- Develop equipment maintenance programs, coordinate maintenance activities, and ensure spare parts availability
- Lead commissioning and qualification of systems in alignment with GMP requirements
- Provide rotational on-call support for 24/7 upstream and downstream system reliability
Requirements
- Bachelor's degree in Chemical or Mechanical Engineering
- 6+ years relevant work experience in biopharmaceutical operations/manufacturing
- 5+ years experience with downstream unit operations and GMP facility equipment
- Knowledge of cell culture reactors, centrifugation, chromatography, tangential flow filtration systems
- Proficiency in root cause analysis, statistical process control, or six sigma methodologies
- Experience in regulated environments and familiarity with cGMP quality systems
- Ability to lead technical problem-solving and equipment troubleshooting
Vacancy posted a month ago
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