Utility Engineer

sgs-job-5317

Engineering
 California
Utility Systems
WFI
WRO
Clean Steam
GMP
FDA Compliance
Process Engineering

Contract - 6 Months

Location : Vacaville, CA The Utility Engineer serves as a subject matter expert for plant utility systems, ensuring reliable, compliant, and efficient operation of utilities that support manufacturing. This role provides technical leadership for utility systems including WFI, WRO, clean steam, water distribution, and related infrastructure in a GMP-regulated environment. The engineer will support operations, lead engineering projects, maintain regulatory compliance, and drive continuous improvement initiatives to ensure uninterrupted manufacturing.

Job Responsibilities:

  • Identify, analyze, and implement improvements for utility, facility, and process systems.
  • Provide technical support for utility systems including WFI, WRO, clean steam, water pretreatment, and distribution systems.
  • Monitor utility system performance and troubleshoot equipment or process issues.
  • Ensure uninterrupted utility supply to support manufacturing operations.
  • Lead or support engineering projects through design, construction, commissioning, validation, and project close-out.
  • Develop and review project documentation including URS, RFQs, specifications, PFDs, P&IDs, FAT/SAT/IQ protocols, and contractor packages.
  • Support deviations, investigations, CAPAs, and audit readiness activities.
  • Ensure utility systems comply with FDA, cGMP, and other regulatory requirements.
  • Perform root cause analysis and implement corrective and preventive actions.
  • Collaborate with Manufacturing, Quality, Maintenance, Facilities, and Global Engineering teams.
  • Provide technical guidance to utility operators and maintenance personnel.
  • Drive continuous improvement initiatives to optimize system performance and engineering standards.

Skills:

  • Utility systems engineering (WFI, WRO, clean steam, water systems)
  • Process engineering in GMP/biopharmaceutical environments
  • Engineering project lifecycle management
  • FDA, EMA, and cGMP regulatory compliance
  • Engineering documentation (PFDs, P&IDs, URS, FAT/SAT/IQ)
  • Root cause analysis and CAPA management
  • Validation and commissioning processes
  • Instrumentation and ISA standards
  • Troubleshooting and system optimization
  • Strong communication and cross-functional collaboration.

Education/Experience:

  • Bachelor's degree in Mechanical, Chemical, Electrical, Industrial Engineering, or a related Engineering discipline.
  • 3–8+ years of experience in utilities or process engineering, preferably within a GMP-regulated manufacturing environment.
  • Experience supporting water systems, clean steam, compressed gases, wastewater, and process utility infrastructure is preferred.

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