Job Description
Job Description
Senior Mechanic, Water Systems
About Penn Life Sciences
Penn Life Sciences (PLS) is a rapidly growing pharmaceutical manufacturer dedicated to producing high-quality sterile generic drug products. Headquartered in Langhorne, Pennsylvania, PLS is developing a modern, U.S.-based sterile manufacturing facility designed to meet the highest FDA and global cGMP standards. Our mission is to strengthen domestic pharmaceutical supply, enhance patient access to affordable, life-saving medications, and uphold the values of integrity, innovation, and scientific excellence in everything we do.
What You’ll Do
The Senior Mechanic, Water Systems is responsible for owning the operation, maintenance, and reliability of all GMP water and clean steam systems supporting sterile pharmaceutical manufacturing. This role serves as the site subject matter expert (SME) for Purified Water (PW), Water for Injection (WFI), and Clean Steam systems, ensuring continuous compliance, inspection readiness, and operational excellence. The position plays a critical role in supporting manufacturing, quality, and engineering teams by ensuring water systems consistently meet regulatory, operational, and quality requirements.
Key Responsibilities
- Operate, monitor, and maintain GMP water and clean steam systems, including PW, WFI, Clean Steam, and all associated generation, storage, and distribution equipment.
- Perform routine and advanced preventive maintenance on system components such as RO units, EDI systems, stills, heat exchangers, storage tanks, pumps, valves, UV units, and distribution loops.
- Independently troubleshoot system alarms, excursions, pressure/flow deviations, temperature issues, and adverse microbiological or conductivity trends.
- Ensure water and clean steam systems remain in a continuous state of GMP inspection readiness, including housekeeping, documentation accuracy, labeling, and system condition.
- Execute and document maintenance activities within the CMMS, including work orders, preventive maintenance tasks, corrective actions, and spare parts usage.
- Collect, review, and trend system performance data (e.g., temperature, conductivity, TOC, flow, pressure) to proactively identify reliability or compliance risks.
- Support sampling activities, sanitizations, thermal cycles, and system startups or shutdowns in coordination with Quality and Operations.
- Participate in deviation investigations, root cause analyses, CAPAs, and change control activities related to water and clean steam systems.
- Support validation activities including IQ/OQ/PQ execution, periodic requalification, and system modifications or upgrades.
- Interface with vendors and contractors performing work on water systems to ensure adherence to GMP, safety, and scope requirements.
- Interpret and apply P&IDs, system drawings, SOPs, and OEM documentation related to GMP utilities.
- Provide hands-on training and technical guidance to Facilities & Engineering personnel to strengthen system knowledge, redundancy, and continuity.
- Recommend improvements to preventive maintenance strategies, spare parts management, system reliability, and lifecycle planning.
- Maintain compliance with all applicable cGMP, FDA, OSHA, EHS, and site safety requirements.
- Perform additional duties as assigned in support of Facilities & Engineering operations.
What We’re Looking For
Experience:
- Minimum of 5 years of hands-on experience supporting GMP water systems in a pharmaceutical, biotech, or other regulated manufacturing environment.
- Demonstrated experience with Purified Water (PW) and/or Water for Injection (WFI) generation and distribution systems.
- Prior experience serving as a primary or sole owner of water system maintenance and troubleshooting strongly preferred.
Education:
- High school diploma or equivalent required.
- Technical or trade training in mechanical systems, utilities, or industrial maintenance strongly preferred.
- A combination of relevant education and experience will be considered.
Skills & Knowledge:
- Expert-level knowledge of GMP water systems, including PW, WFI, Clean Steam, and associated distribution loops.
- Strong understanding of water system critical parameters, controls, and performance monitoring.
- Proficiency in mechanical maintenance and troubleshooting of pumps, valves, piping systems, instrumentation, and heat transfer equipment.
- Working knowledge of basic electrical and controls concepts related to utility equipment (motors, sensors, interlocks, alarms).
- 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.
- Proficiency with CMMS platforms and standard computer applications such as Microsoft Office.
- Flexibility to work shifts, weekends, holidays, and respond to after-hours calls as needed to support critical utility systems.
What We Offer
- Competitive compensation with annual performance bonus eligibility
- Annual merit-based pay increases
- Automatic enrollment in a 401(k) at 3% pre-tax with 50% company match on the first 6% contributed
- Paid Time Off
- 10 paid company holidays
- Comprehensive medical, dental, vision, and life insurance coverage
- Professional development reimbursement
- Career growth opportunities
Schedule
- Full-time, on-site 1st-shift position
- Flexibility required to support critical GMP utilities, including weekends, holidays, and after-hours call response as needed
Company DescriptionPenn Life Sciences (PLS) is a rapidly growing pharmaceutical manufacturer dedicated to producing high-quality sterile generic drug products. Headquartered in Langhorne, Pennsylvania, PLS is developing a modern, U.S.-based sterile manufacturing facility designed to meet the highest FDA and global cGMP standards. Our mission is to strengthen domestic pharmaceutical supply, enhance patient access to affordable, life-saving medications, and uphold the values of integrity, innovation, and scientific excellence in everything we do.
Company Description
Penn Life Sciences (PLS) is a rapidly growing pharmaceutical manufacturer dedicated to producing high-quality sterile generic drug products. Headquartered in Langhorne, Pennsylvania, PLS is developing a modern, U.S.-based sterile manufacturing facility designed to meet the highest FDA and global cGMP standards. Our mission is to strengthen domestic pharmaceutical supply, enhance patient access to affordable, life-saving medications, and uphold the values of integrity, innovation, and scientific excellence in everything we do.