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

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Vacancy posted 18 days ago

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