Clean Utilities Sr Engineer
Amgen Inc
Senior engineering role focused on clean and plant utility systems at Amgen's biopharmaceutical manufacturing facility in North Carolina. Responsibilities include system ownership, design and commissioning support, maintenance program development, regulatory compliance, and operational troubleshooting to ensure continuous production capability.
Responsibilities
- Own clean and plant utility systems supporting drug substance production operations
- Support design, construction, startup, and qualification of new or modified systems
- Lead implementation of engineering improvements and capital projects of small to medium scope
- Develop maintenance programs, manage spare parts inventory, and coordinate maintenance execution
- Troubleshoot production issues, lead root cause analysis, and implement corrective actions
Requirements
- Bachelor's degree in Chemical, Mechanical, or Electrical Engineering preferred
- 4+ years relevant experience with 2+ years in biopharmaceutical manufacturing operations
- Direct knowledge of GMP pharmaceutical utility systems: water, clean steam, compressed air
- Experience with facility control systems operation and troubleshooting
- Proficiency in data-driven problem-solving: RCA, SPC, Six Sigma, predictive maintenance
- Working knowledge of regulated environments: cGMP, OSHA, EPA, quality systems
- Leadership, technical writing, and strong communication skills
Vacancy posted 6 days ago
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