Project Engineer, Quality Engineering

Title:
Utility Engineer

Location:

Vacaville, CA,
Duration: 12 months

Job Description:
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.



Key Responsibilities
1. Technical & Engineering
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)

2. Operations Support
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

3. Projects & Capital Execution
Lead or support engineering projects across 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

4. Compliance & Documentation
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

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

6. Collaboration & Support
Work cross-functionally with:
Manufacturing, Quality, Maintenance, and Facilities
Provide technical guidance to utility operators and technicians
Support Global Engineering on major projects

Qualifications:
Education
Bachelor’s degree in Engineering (Mechanical, Chemical, Electrical, or Industrial)

Experience
Typically 3–8 years in utilities or process engineering (GMP environment preferred)

Core Competencies
Strong understanding of:
Utility systems and infrastructure
Engineering design principles
Regulatory requirements (FDA, EMA, cGMP)

Knowledge of:
Project lifecycle and validation processes
Instrumentation and ISA standards
Strong troubleshooting, communication, and collaboration skills

Utilities Systems
Based on your Utilities Engineering scope:
Water systems: WFI, WRO, clean water loops
Steam systems: clean steam generation/distribution
Gases and compressed air
Wastewater and chemical distribution systems

Quick Summary (for hiring use)
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