The Maintenance Supervisor is responsible for the Preventive and Corrective maintenance of plant mechanical systems in a cGMP environment. Systems include USP grade Water and Steam systems, HVAC (includes HEPA Air Handlers), chillers, generators, boilers, and equipment that supports Aseptic Processes (Autoclave, Depyrogenation Oven, VHP Generators and Lyophilizer). The Facilities Manager is also responsible for overseeing the metrology and instrumentation areas to ensure that all equipment remains calibrated and in proper working order at all times.
This position will ensure that all maintenance and metrology/instrumentation tasks are performed in compliance with cGMP and applicable SOPs. Assists with performing equipment troubleshooting and recommends appropriate remediation. Coordinate with vendors, in-house managers and external equipment service providers to maintain facilities and instrumentation in support of all operations. Maintain cGMP compliance and a state of audit readiness at all times. Also works with Management team to resolve outstanding work orders related to equipment, facility and instrument issues.
The Maintenance Supervisor is responsible for tracking and prioritizing Work Orders related to Preventative Maintenance, Recurring Calibrations and Daily requests for Work Orders. The Maintenance Supervisor will also coordinate the inventory of critical spare parts required to keep all departments operating under normal conditions.
The Maintenance Supervisor will be required to wear the required clothing to perform job functions in an aseptic environment, comply with safety requirements, be on-call for emergencies, and periodically work off hours.
- Coordinate the maintenance of all mechanical systems.
- Coordinate the calibration and qualification of all instrumentation and related equipment.
- Insure that equipment monitoring and proper documentation is performed.
- Audit cGMP documentation of work performed.
- Participates in cross functional teams to meet deadlines and achieve project objectives
- Maintain spare parts inventories
- Ability to interpret engineering drawings
- Use applicable software such as MS Office, MS Project and Work Order software
- Interact and provide direction to direct reports and service providers/vendors relevant to area of responsibility
- Support any function of the other departments as necessary (e.g. Engineering and Validations)
- Ensure that work is performed within established safety guidelines.
- Insure that clean and orderly work areas are maintained.
- Ability to write, revise and review relevant protocols and procedures.
- Should have a minimum of a B.A. or B.S. in a technical field and/or equivalent degree, advanced degree preferable.
- 5 to 10 years of Maintenance/Instrumentation Supervision experience in a regulated industry, preferable in a pharmaceutical environment is required.
- Have the ability to troubleshoot equipment problems using a variety of tools and diagnostic instrumentation.
- Ability to lift 50 pounds.
- Familiarity with Pharmaceutical processing equipment – Steam Sterilizers, Depyrogenation Ovens, Lyophilizers, Water Systems, VHP Generators, Lab Equipment, Precision Scales, HEPA Air Handlers, Isolators and Water Treatment Systems.
- Familiarity with automated control systems and PLC interfaces