Job Title: Senior Mechanic, Water Systems

Work Location: Bucks County, Pennsylvania

Summary:

Own the operations, maintenance, and reliability of all GMP water and clean steam systems supporting pharmaceutical manufacturing. Ensure continuous compliance, inspection readiness, and operational excellence of purified water (PW), water for injection (WFI), and associated distribution systems. Serve as the site subject matter expert (SME) for GMP water systems, providing troubleshooting leadership, preventive maintenance strategy, and technical guidance. Support manufacturing, quality, and engineering teams by ensuring water systems consistently meet regulatory, operational, and quality requirements.

Responsibilities:

• Operate, monitor, and maintain GMP water systems, including Purified Water (PW), Water for Injection (WFI), Clean Steam, and all associated generation, storage, and distribution equipment.
• Perform routine and advanced preventive maintenance on water system components such as RO units, EDI systems, stills, heat exchangers, storage tanks, pumps, valves, UV units, and distribution loops.
• Independently troubleshoot water system excursions, alarms, pressure/flow deviations, temperature issues, and microbiological or conductivity trends.
• Ensure all water systems remain in a continuous state of GMP inspection readiness, including housekeeping, documentation, labeling, and system condition.
• Execute and document maintenance activities in the CMMS, including work orders, PMs, corrective actions, and spare parts usage.
• Collect, review, and trend system data (e.g., temperature, conductivity, TOC, flow, pressure) to proactively identify performance or compliance risks.
• Support sampling activities, sanitizations, thermal cycles, and system startups/shutdowns in coordination with Quality and Operations.
• Participate in deviation investigations, root cause analyses, CAPAs, and change control activities related to water systems.
• Support validation activities, including IQ/OQ/PQ execution, periodic requalification, and system modifications.
• Interface with vendors and contractors performing work on water systems, ensuring adherence to GMP, safety, and scope requirements.
• Interpret and apply P&IDs, system drawings, SOPs, and OEM documentation related to water and clean steam utilities.
• Provide hands-on training and technical guidance to Facilities & Engineering personnel to build system familiarity, operational redundancy, and knowledge continuity for GMP water and clean steam systems.
• Recommend improvements to PM strategies, spare parts management, system reliability, and lifecycle maintenance planning.
• Maintain compliance with all applicable cGMP, FDA, OSHA, EHS, and site safety requirements.
• Perform other duties as assigned in support of Facilities & Engineering operations.

Qualifications:

• High School Diploma or equivalent required. Technical or trade training in mechanical systems, utilities, or industrial maintenance strongly preferred.
• Minimum 5 years of hands-on experience supporting GMP water systems in a pharmaceutical, biotech, or regulated manufacturing environment.
• Demonstrated experience with PW and/or WFI generation and distribution systems required.
• Prior experience serving as a primary or sole owner of water system maintenance and troubleshooting strongly preferred.
• Strong understanding of water system critical parameters, controls, and performance monitoring.
• Ability to read and interpret P&IDs, system schematics, SOPs, and technical documentation.
• Familiarity with cGMP requirements related to utilities, data integrity, documentation, and inspection readiness.
• Proficient in CMMS platforms and standard computer applications (e.g., Microsoft Office).

Published Category: Manufacturing & Technical Operations