Project Engineer II

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.

• Identify, analyze, and design improvements for utility, facility, and process systems
• Provide technical support for utility systems such as:
• Water pretreatment and distribution
• 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:
• 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
• 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
• Regulatory requirements (FDA, EMA, cGMP)
• Knowledge of:
• 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
• 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