Utility Engineer

Utility Engineer

We are seeking an experienced Utility Engineer to join a leading biopharmaceutical manufacturing facility in Vacaville, CA. In this role, you will serve as the technical expert for critical plant utility systems, ensuring reliable, compliant, and efficient operation of manufacturing utilities. You will partner with Manufacturing, Facilities, Maintenance, and Quality teams to support day-to-day operations while driving engineering improvements and capital projects.

This is an excellent opportunity for engineers with experience in pharmaceutical, biotechnology, or other GMP-regulated manufacturing environments.

Responsibilities:

• Serve as the subject matter expert (SME) for site utility systems.
• Support and maintain critical utility systems including:
• Water for Injection (WFI)
• Reverse Osmosis (RO/WRO)
• Clean Water Systems
• Clean Steam Systems
• Process Utilities
• Compressed Air & Gas Systems
• Wastewater Systems
• Monitor utility system performance and identify opportunities for optimization.
• Troubleshoot equipment and utility system issues to support uninterrupted manufacturing.
• Lead or support engineering projects from design through commissioning and validation.
• Develop and review engineering documentation including PFDs, P&IDs, engineering specifications, URS, FAT/SAT, and IQ documentation.
• Support deviations, investigations, CAPAs, change controls, and regulatory inspections.
• Coordinate contractors and oversee construction and project execution.
• Perform root cause analysis and implement corrective and preventive actions.
• Collaborate with Manufacturing, Quality, Maintenance, Validation, and Facilities teams to improve system performance and reliability.

Required Qualifications:

• Bachelor's degree in Mechanical, Chemical, Electrical, Industrial Engineering, or a related engineering discipline.
• 3+ years of Utility Engineering, Facilities Engineering, or Process Engineering experience.
• Experience working in a GMP-regulated pharmaceutical, biotechnology, or life sciences manufacturing environment.
• Strong knowledge of utility systems including WFI, RO/WRO, Clean Steam, Water Systems, Process Utilities, and Compressed Air.
• Experience with engineering documentation including P&IDs, PFDs, specifications, and validation documents.
• Knowledge of FDA, cGMP, and engineering compliance requirements.
• Excellent troubleshooting, analytical, and communication skills.
• Ability to support off-hours troubleshooting when required.

Preferred Qualifications:

• Experience leading capital engineering projects.
• Knowledge of commissioning, qualification, and validation (CQV).
• Experience supporting regulatory audits and inspections.
• Familiarity with ISA standards and instrumentation systems.