Utility Process Engineer – Reliability Program/Fit & Finish
$156,000–$187,200 year
On-siteKenosha, Wisconsin, United States
Job Summary
Conduct equipment condition assessments, utility system walk-downs, and root cause investigations to improve preventive maintenance plans, spare parts strategies, and overall utility reliability for aseptic syringe and vial lines. Lead reliability improvement projects targeting WFI, purified water, clean steam, HVAC, compressed air, and electrical distribution to reduce recurring failures and increase operational uptime. Support fit-and-finish compliance by documenting surface finishes, weld logs, hygienic design features, and material certifications while managing remediation projects, field corrections, and punch list closure aligned with GMP and EU Annex 1 principles. Perform failure reviews, identify chronic utility issues, and collaborate with maintenance, engineering, quality, and operations teams to ensure facility readiness for active GMP pharmaceutical manufacturing.
Required Qualifications
- Bachelor's degree in Engineering or a related technical discipline
- 5+ years of utility process engineering, facilities engineering, reliability engineering, or maintenance engineering experience in a GMP-regulated pharmaceutical, biotechnology, or life sciences manufacturing environment
- Experience supporting utility systems in or around aseptic manufacturing operations
- Hands-on experience with critical utility systems such as: Water for Injection, Purified Water, Clean Steam, Clean compressed air, Process gases, HVAC, Electrical distribution and supporting facility infrastructure
- Strong understanding of GMP documentation, change control, deviations, CAPA, and quality system expectations
- Experience improving preventive maintenance programs, reliability strategies, equipment uptime, or maintenance effectiveness
- Ability to perform field walkdowns, identify practical reliability risks, and translate observations into actionable improvements
- Must be available for weekend shifts
- Must be able to lift 50 lbs
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