Clean Utilities Engineer

We are seeking an experienced Clean Utilities Engineer to support utility and facility systems within a GMP-regulated pharmaceutical manufacturing environment. This role provides hands-on engineering and field support for the operation, troubleshooting, maintenance, and improvement of critical utility systems.

• Provide technical and field support to Maintenance and Operations teams for troubleshooting, testing, maintenance, and daily utility operations.
• Support clean utilities, including WFI, purified water (PW), RO, clean steam, and process gases.
• Support plant utilities, including HVAC, chilled water, boilers, compressed air, and vacuum systems.
• Troubleshoot equipment issues, alarms, and system performance problems and support root cause investigations and corrective actions.
• Provide engineering support for cleanroom HVAC, including AHUs, pressure cascades, airflow, temperature/humidity control, HEPA filtration, and environmental conditions.
• Support preventive and predictive maintenance programs, PM optimization, reliability improvements, spare-parts planning, and equipment lifecycle strategies.
• Support deviations, change controls, CAPAs, investigations, and technical assessmentsrelated to utility and facility systems.
• Support utility and facility projects, including upgrades, remediation, capacity expansions, design reviews, risk assessments, commissioning, qualification, and requalification.
• Work closely with Maintenance, Manufacturing, Validation, Quality, Automation, EHS, contractors, and vendors to ensure safe, reliable, and GMP-compliant operations.

• Bachelor's degree in Mechanical, Electrical, Industrial, Chemical Engineering, or a related engineering discipline.
• 5-10 years of utilities or facilities engineering experience in pharmaceutical, biotechnology, CDMO, or another GMP-regulated manufacturing environment.
• Hands-on experience testing, troubleshooting, and diagnosing utility systems and equipment in an operating manufacturing facility.
• Strong knowledge of WFI, PW, RO, clean steam, process gases, HVAC, and plant utilities.
• Experience with cleanroom HVAC systems, including AHUs, pressure cascades, airflow, temperature/humidity control, and HEPA filtration.
• Experience with GMP documentation, deviations, change controls, CAPAs, investigations, and root cause analysis.
• Experience supporting maintenance/reliability programs, commissioning, qualification, system upgrades, and utility lifecycle activities.
• Working knowledge of GMP requirements, ALCOA+ data integrity principles, QMS systems, and pharmaceutical regulatory expectations.