Senior Critical Utilities Engineer - Aseptic Manufacturing

Senior Critical Utilities Engineer – Aseptic Manufacturing

Location: Kenosha County, WI (Onsite)
Contract: 18–24 Months with potential extensions

Automated Systems, Inc. is seeking an experienced Senior Critical Utilities Engineer to support our client's pharmaceutical manufacturing expansion in Kenosha County, WI. In this role, you will be responsible for improving the reliability, performance, and maintainability of critical GMP utility systems that support aseptic manufacturing operations. You will collaborate with Engineering, Maintenance, Operations, Validation, and Quality teams to optimize systems including Water for Injection (WFI), Purified Water, Clean Steam, HVAC, compressed air, process gases, and supporting facility infrastructure.

This highly visible role focuses on enhancing equipment reliability, reducing unplanned downtime, optimizing preventive maintenance programs, leading root cause investigations, and driving continuous improvement initiatives that support operational excellence. You will also play a key role in ensuring utility systems and supporting infrastructure comply with GMP standards and EU Annex 1 expectations through improvements in hygienic design, material traceability, weld documentation, and facility readiness.

This opportunity is ideal for a hands-on engineer who enjoys solving complex utility and reliability challenges, working cross-functionally with technical teams, and making a measurable impact within a state-of-the-art aseptic pharmaceutical manufacturing facility.

You'll Make an Impact By:

• Improving the reliability and performance of critical GMP utility systems supporting aseptic manufacturing.
• Optimizing preventive maintenance strategies to reduce downtime and improve equipment availability.
• Leading equipment condition assessments, field walkdowns, failure investigations, and root cause analyses.
• Identifying recurring utility issues and implementing long-term corrective actions.
• Partnering with Maintenance, Engineering, Operations, Validation, and Quality on reliability improvement initiatives.
• Supporting utility system modifications, commissioning activities, and operational readiness.
• Reviewing and improving documentation including weld logs, material certifications, surface finishes, and hygienic design records.
• Supporting facility remediation projects to ensure compliance with GMP and EU Annex 1 requirements.
• Driving continuous improvement projects that increase equipment reliability and operational efficiency.

Education, Experience & Skill Qualifications:

• BS in Mechanical, Chemical, Electrical, Industrial, or related Engineering discipline.
• 5 years of engineering experience supporting pharmaceutical, biotechnology, or life sciences manufacturing.
• Strong experience with GMP critical utility systems, including:
• • Water for Injection (WFI)
  • Purified Water
  • Clean Steam
  • HVAC
  • Compressed Air
  • Process Gases
  • Facility Utility Infrastructure
• Experience improving equipment reliability, preventive maintenance programs, or asset performance.
• Knowledge of GMP documentation, Change Control, CAPA, Deviations, and Quality Systems.
• Experience supporting aseptic manufacturing or other highly regulated production environments preferred.
• Ability to perform field assessments and translate observations into practical engineering solutions.