Utilities Mechanic (Sterile Water Systems)
Job Description Job Description About Penn Life Sciences Penn Life Sciences (PLS) is a rapidly growing pharmaceutical manufacturer dedicated to producing sterile 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 Stationary Engineer is responsible for the operation, monitoring, and maintenance of critical facility and utility systems that support sterile injectable manufacturing operations. This role ensures all plant utilities remain in a validated, compliant, and inspection-ready state in accordance with cGMP, FDA, and regulatory requirements. The Stationary Engineer plays a key role in maintaining environmental control systems essential to aseptic processing, while supporting safe, reliable, and efficient facility operations through proactive monitoring, troubleshooting, and maintenance activities. Key Responsibilities: • Operate and monitor plant utility systems including boilers, plant steam, chilled water, HVAC systems, compressed air, and purified water systems . • Perform routine inspections and system rounds to verify equipment performance and identify abnormalities or deviations. • Adjust system controls to maintain environmental conditions required for cleanroom classifications and aseptic manufacturing operations. • Respond to alarms, system faults, and operational issues; troubleshoot and resolve problems to minimize downtime and production impact. • Perform preventative maintenance and support corrective maintenance activities in accordance with SOPs and established schedules. • Maintain accurate and contemporaneous documentation of system readings, inspections, and maintenance activities in logbooks and CMMS systems. • Support clean utility systems including WFI, purified water, clean steam, and process gases to ensure operation within validated states. What We’re Looking For Experience: • 5–10 years of experience operating and maintaining plant utilities, boilers, or stationary equipment in a regulated manufacturing or industrial environment. • Experience in pharmaceutical, biotechnology, or other cGMP-regulated environments strongly preferred. • Demonstrated experience with boiler systems, HVAC systems, and industrial utility equipment required. Education: • High school diploma or equivalent required. • Technical training, trade certification, or formal apprenticeship in stationary engineering, HVAC, boiler operation, or a related field strongly preferred. Skills & Knowledge: • Strong working knowledge of plant utility systems including boilers, steam systems, chillers, cooling towers, and HVAC systems. • Understanding of clean utilities such as WFI, purified water, and clean steam systems in a GMP environment. • Ability to read and interpret P&IDs, mechanical drawings, electrical schematics, and technical manuals. • Familiarity with Building Management Systems (BMS), SCADA systems, and automated control systems. • Knowledge of preventative maintenance practices and troubleshooting methodologies for mechanical systems. • Understanding of cGMP, FDA regulatory requirements, and Good Documentation Practices (GDP/ALCOA principles). • Strong problem-solving skills and ability to respond effectively to real-time operational issues. • Proficiency in CMMS systems and Microsoft Office applications. • EPA Universal (608) certification preferred. • Stationary Engineer or Boiler Operator license strongly preferred where applicable. 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 • Tuition reimbursement for children and childcare expense reimbursement Schedule • Full-time, on-site position (Monday–Friday, standard business hours; flexibility required to support facility operations as needed) 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. 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.
