Utilities Engineer

Key Accountabilities / Core Job Responsibilities

• Lead lifecycle management of GMP utility systems (specification, procurement, installation, commissioning, qualification/CQV) in compliance with FDA GMP requirements.
• Manage Change Control for utility systems, including impact assessments, documentation, and timely implementation.
• Maintain accurate utility system master data (specifications, capacities, operating parameters) for compliance and audit readiness.
• Monitor and optimize performance of critical utilities (WFI, clean steam, HVAC, compressed air, nitrogen) within validated ranges.
• Support maintenance and repair activities, including troubleshooting and partnering with maintenance teams to restore operations.
• Develop and implement reliability and preventive maintenance strategies, including spare parts optimization to minimize downtime.
• Conduct periodic reviews of utility systems (performance trending, capacity evaluations, compliance checks).
• Coordinate facility and utility upgrades with internal teams and contractors, ensuring minimal disruption and GMP compliance.
• Revise and maintain P&IDs and engineering documentation; conduct risk assessments; support deviations/CAPAs; provide training for continuous improvement.

• Bachelor’s degree in mechanical engineering, electrical engineering, or related technical discipline with 7+ years of experience (or Master’s degree with 4+ years).
• Biopharmaceutical or GMP-regulated industry experience preferred.
• Hands‑on experience with critical utility systems (WFI, clean steam, HVAC, building automation systems, compressed gases).
• Experience with commissioning/qualification/validation (CQV) of utility systems.
• Familiarity with regulatory expectations (FDA, EMA, ISPE Baseline Guides, ASME BPE).
• Ability to travel up to 10% by air and road.
• Demonstrated cross‑functional collaboration and influencing skills.
• Confidence to lead through uncertainty; strong communication (oral and written).
• Physical requirements:
  
  wear specialized gowning, lift/manipulate items over 25 lbs, climb ladders, stand for extended periods.

Competitive total rewards package including 401k, healthcare coverage, and ESPP, plus other benefits.