Job DescriptionUtility Process Engineer - Aseptic Utilities Reliability & Fit/FinishLocation: Kenosha County, WI - Onsite
Contract Duration: 18-24 months
Schedule: On-site, standard business hours with occasional off-shift support as required for shutdowns, investigations, project execution, or operational needs.
Work Environment: Active GMP pharmaceutical manufacturing facility supporting aseptic manufacturing operations
Position OverviewAutomated Systems, Inc. is seeking an experienced Utility Process Engineer to support our client's Kenosha County manufacturing site. This role will focus on critical utility systems that support aseptic syringe and vial lines, with an emphasis on utility reliability, preventive maintenance improvement, operational uptime, and facility fit-and-finish compliance. The engineer will work closely with site utilities, maintenance, engineering, quality, validation, and operations teams to ensure that utility systems are reliable, maintainable, GMP-compliant, and capable of supporting world-class aseptic manufacturing performance.
A major focus of the role will be improving the reliability of utilities through better preventive maintenance strategies, equipment condition assessments, root cause investigations, reliability improvement projects, and practical fixes to operational or ergonomic issues. The role will also support fit-and-finish compliance for an aseptic facility, including documentation of surface finishes, weld logs, hygienic design considerations, and improvement projects aligned with GMP expectations and EU Annex 1 principles.
Key ResponsibilitiesUtility Reliability & Uptime- Support critical utilities servingaseptic filling and vial manufacturing operations, including WFI, purifiedwater, clean steam, HVAC, compressed air, process gasses, electricaldistribution, and supporting infrastructure.
- Review existing preventive maintenanceplans and recommend improvements to PM frequency, task content, spareparts strategy, inspection points, and maintenance effectiveness.
- Identify utility reliability risks thatcould impact aseptic operations, batch execution, environmental control,or facility uptime.
- Lead or support reliability improvementprojects intended to increase utility availability, reduce recurringfailures, and improve long-term equipment performance.
- Perform equipment condition assessments,utility system walk-downs, failure reviews, and root cause investigations.
- Work with maintenance and operations toidentify chronic utility issues, nuisance alarms, difficult-to-maintainequipment, and recurring downtime drivers.
Fit & Finish / Aseptic Facility Compliance- Support fit-and-finish activities forutility systems and facility areas associated with aseptic manufacturing.
- Review and document surface finishrequirements, weld logs, material certifications, hygienic designfeatures, and other cleanability-related design features.
- Identify gaps in facility or utilityfit-and-finish that may impact GMP compliance, clean ability, contaminationcontrol, or Annex 1 expectations.
- Lead or support remediation projects toimprove fit-and-finish compliance, including repairs, replacements,documentation updates, field corrections, and punch list closure.
- Ensure appropriate documentation existsfor surface finishes, weld records, material compatibility, clean ability,and other aseptic facility considerations.
RequirementsRequired Qualifications- Bachelor's degree in Engineering or arelated technical discipline.
- 5+ years of utility process engineering,facilities engineering, reliability engineering, or maintenanceengineering experience in a GMP-regulated pharmaceutical, biotechnology,or life sciences manufacturing environment.
- Experience supporting utility systems inor around aseptic manufacturing operations.
- Hands-on experience with critical utilitysystems such as:
- Waterfor Injection
- PurifiedWater
- CleanSteam
- Cleancompressed air
- Processgases
- HVAC
- Electricaldistribution and supporting facility infrastructure
- Strong understanding of GMPdocumentation, change control, deviations, CAPA, and quality systemexpectations.
- Experience improving preventivemaintenance programs, reliability strategies, equipment uptime, ormaintenance effectiveness.
- Ability to perform field walkdowns,identify practical reliability risks, and translate observations intoactionable improvements.
