Supervisor, GMP Facilities

Position Summary:

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This role is for a highly skilled and detail-oriented Facilities Supervisor responsible for overseeing maintenance operations in a regulated Good Manufacturing Practice (GMP) environment. The position ensures that all equipment, utilities, and facilities are maintained in a compliant, safe, and efficient manner to support manufacturing and laboratory operations.

Work Model:

Core Lab & Ops: This role typically requires that the majority of the work be conducted on-site.

Responsibilities:

– Supervise and coordinate daily activities of maintenance technicians and contractors, ensuring efficient task delegation and execution 

– Ensure all maintenance work complies with GMP, safety, and environmental regulations 

– Plan, schedule, and manage preventive and corrective maintenance schedules for GMP-critical equipment and systems to minimize downtime and ensure operational continuity 

– Maintain accurate and timely documentation of maintenance activities in the Computerized Maintenance Management System (CMMS) 

– Lead troubleshooting efforts and conduct root cause analysis for equipment failures, implementing corrective actions 

– Collaborate with Quality Assurance, Manufacturing, and Engineering teams to ensure equipment and facility readiness for production and audits 

– Participate in audits and inspections conducted by internal teams and regulatory agencies, providing necessary documentation and support 

– Train and mentor maintenance staff on GMP procedures, technical skills, and best practices in maintenance planning and execution 

– Support deviation investigations and CAPA management by providing technical input, maintenance history, and contributing to timely resolution and documentation 

Requirements:

– Associate or bachelor’s degree in engineering, Facilities Management, or a related field (or equivalent combination of education and experience) 

– 6+ years of maintenance experience in a GMP-regulated pharmaceutical, biotechnology, or medical device environment 

– 2+ years of supervisory or team lead experience in a maintenance or facilities role 

– Strong knowledge of GMP, FDA, EMA, and other applicable regulatory requirements and industry standards 

– Proficiency with CMMS (e.g. Blue Mountain, Infor EAM, Maximo) and Microsoft Office applications (Excel, Word, Outlook, PowerPoint)  Excellent communication, leadership, and problem-solving skills with the ability to manage cross functional collaboration 

– Demonstrated experience in planning, scheduling, and executing preventive and corrective maintenance programs 

– Familiarity with HVAC, clean utilities (e.g., WFI, clean steam, compressed air), and critical manufacturing equipment 

– Experience supporting deviation investigations, root cause analysis, and CAPA implementation 

– Ability to read and interpret technical drawings, equipment manuals, and engineering specifications 

– Strong organizational skills and attention to detail in a fast-paced, compliance-driven environment Physical Demand Requirements: 

– Stand for extended periods of time wih periodic stooping / bending / kneeling. 

– Ability to climb ladders and stairs of various heights. 

– Able to lift, push, pull up to 50lbs. 

– Work in a controlled environment requiring GxP gowning and wear protective clothing over the head, face, hands, feet, and body. This requires the ability to change clothes into appropriate gowning and personal protective equipment.

– Certain tasks may require use of a respirator; medical clearance will be required in advance. 

– Must remove all make-up, jewelry, and contract lenses while in the manufacturing environment. 

– Working in termperature-controled environments (cold rooms). 

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