Utility Engineer

Position:
Project Engineer II, Req#: 910

Client’s

Title:

Utility Engineer

Location:
Vacaville, CA(100% onsite)
Duration: 6+Months Contract with the possibility of extension

Focus
:
Utility system reliability, compliance, and performance

Core role: Technical SME + project engineer + operations support

Environment
: GMP / biopharma manufacturing

Impact
:
Ensures uninterrupted manufacturing and regulatory compliance

The Utility Engineer serves as a subject matter expert in plant utility systems (e.g., WFI, WRO, and clean steam) and supports manufacturing operations to ensure reliable, compliant, and efficient utility performance at the site.

• Bachelor’s degree in engineering (Mechanical, Chemical, Electrical, or Industrial)
• Experience:
  
  Typically, 3–8+ years in utilities or process engineering (GMP environment preferred)

• Utility systems and infrastructure
• Engineering design principles
• Regulatory requirements (FDA, EMA, cGMP)

• Project lifecycle and validation processes
• Instrumentation and ISA standards
• Strong troubleshooting, communication, and collaboration skills

• Water systems
  : WFI, WRO, clean water loops
• Steam systems: clean steam generation/distribution
• Gases and compressed air
• Wastewater and chemical distribution systems

• Identify, analyze, and design improvements for utility, facility, and process systems
• Provide technical support for utility systems such as:
• Water pretreatment and distribution
• WFI (Water for Injection)
• Clean steam and process utilities
• Ensure systems meet regulatory and performance requirements (FDA, cGMP, codes)

• Support manufacturing by ensuring an uninterrupted and compliant utility supply
• Perform daily monitoring and analysis of system performance data
• Troubleshoot system/process failures and emergent issues (including off-hours support)
• Support maintenance and operations teams with technical expertise

• Lead or support engineering projects across the full lifecycle:
• Initiation, design, construction, commissioning, and validation
• Develop and review:
• Project scope, schedules, budgets, URS, RFQs, and contractor packages
• Manage construction activities, contractors, and project close-out

• Develop and maintain engineering documentation:
• PFDs, P&IDs, specifications, design reviews, FAT/SAT/IQ protocols
• Support
  :
• Deviations, investigations, CAPAs, and audit readiness
• Ensure systems operate in compliance with GMP and regulatory requirements

• Identify and implement system performance improvements and optimization opportunities
• Perform root cause analysis and drive corrective/preventative actions
• Contribute to the improvement of engineering standards, practices, and procedures

• Manufacturing, Quality, Maintenance, and Facilities
• Provide technical guidance to utility operators and technicians
• Support Global Engineering on major projects