Project Engineer, Quality Engineering

Project Engineer 2

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.

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

Bachelor's degree in Engineering (Mechanical, Chemical, Electrical, or Industrial)

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

Strong understanding of:
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

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

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