Utility Process Engineer – Reliability Program/Fit & Finish

Utility Process Engineer – Reliability Program/Fit & Finish

Location: Kenosha County, WI – On-site

Contract: 18 – 24 months duration                                                                                                                       

•      Develop and implement a site utility reliability program covering critical systems (HVAC, purified water, clean steam, compressed gasses, electrical, and associated utilities)

•      Conduct reliability assessments and equipment condition reviews; document findings and corrective actions in GMP-compliant formats

•      Execute Fit & Finish activities: punch list item closure, startup documentation, acceptance testing coordination, and system turnover packages

•      Identify and prioritize gaps between current utility system documentation and LQS/GQS standards

•      Support drawing remediation coordination for utility-related P&IDs and mechanical documentation

•      Contribute to change control documentation for utility system modifications

•      Collaborate with Maintenance, Validation, and Quality teams on equipment qualification and qualification activities

Requirements

Required Qualifications

•      5+ years of utility process engineering experience in a GMP pharmaceutical or biotech manufacturing environment

•      Hands-on experience with critical utility systems: WFI, purified water, HVAC/HVAC-R, clean steam, compressed air/gases

•      Familiarity with utility reliability frameworks (RCM, PM optimization, or equivalent)

•      Experience with Fit & Finish and system turnover processes in construction/expansion projects

•      Working knowledge of GMP documentation and change control requirements

•      Experience with CMMS platforms (Maximo, SAP PM, or equivalent) for reliability program implementation

•      Familiarity with Quality Standards or equivalent big-pharma utility standards

•      Background in legacy site acquisition, integration, or remediation projects

•      PE license or equivalent professional engineering credential