Utility Engineer

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.