Job Description
Utility Process Engineer - Reliability Program/Fit & Finish
Location: Kenosha County, WI - On-site
Contract: 18 - 24 months duration
Work Environment: Active GxP manufacturing environment. Standard business hours with occasional off-shift coordination
ASI is seeking a Utility Process Engineer to establish and execute a reliability program for critical utility systems at the Kenosha County site, while also supporting Fit & Finish activities required to bring utility infrastructure into full LQS/GQS alignment. This role works alongside the site utilities lead and is integral to ensuring Phase 2 system acceptance is supported and Phase 3 readiness is achievable.
Key Responsibilities
• 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
Preferred Qualifications
• 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