Utility Process Engineer – Aseptic Utilities Reliability & Fit/Finish
Location: 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 Overview
Automated 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 Responsibilities
Utility Reliability & Uptime
- Support critical utilities serving aseptic filling and vial manufacturing operations, including WFI, purified water, clean steam, HVAC, compressed air, process gasses, electrical distribution, and supporting infrastructure.
- Review existing preventive maintenance plans and recommend improvements to PM frequency, task content, spare parts strategy, inspection points, and maintenance effectiveness.
- Identify utility reliability risks that could impact aseptic operations, batch execution, environmental control, or facility uptime.
- Lead or support reliability improvement projects intended to increase utility availability, reduce recurring failures, 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 to identify chronic utility issues, nuisance alarms, difficult-to-maintain equipment, and recurring downtime drivers.
Fit & Finish / Aseptic Facility Compliance
- Support fit-and-finish activities for utility systems and facility areas associated with aseptic manufacturing.
- Review and document surface finish requirements, weld logs, material certifications, hygienic design features, and other cleanability-related design features.
- Identify gaps in facility or utility fit-and-finish that may impact GMP compliance, clean ability, contamination control, or Annex 1 expectations.
- Lead or support remediation projects to improve fit-and-finish compliance, including repairs, replacements, documentation updates, field corrections, and punch list closure.
- Ensure appropriate documentation exists for surface finishes, weld records, material compatibility, clean ability, and other aseptic facility considerations.
Requirements
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.