Manager, Central Utilities Job in Exton, Pennsylvania US
Manager, Central Utilities
Manager, Central UtilitiesPilot Plant - FacilitiesExton, PAThe Manager, Central Utilities is responsible for the building, commissioning, maintenance and functioning of a cGMP pilot plant facility. This facility will manufacture therapeutic monoclonal antibodies to support toxicology studies as well as phase 1 and phase 2 clinical trials.
This individual will oversee facility master planning, equipment installation, maintenance of the central utilities and calibration. This individual will also be responsible for all the utilities’ critical systems including plant steam, chilled water, cooling tower, and boilers. The Manager, Central Utilities will take ownership for the overall maintenance and PM program of the central utilities in the pilot plant facility including the operation of the Building Automation System (BAS).
Excellent interpersonal and communication skills required as well as knowledge of computer systems as this individual will be overseeing qualified CFR 21 part 11 compliant systems. This position will require some off hour emergency response and must be available 24 hours.
Responsibilities
1. Ensure that all central utilities systems are in working order and that the building remains operational and suitable for the manufacturing of clinical material to be used in global clinical trials. These systems include HVAC, lighting, electrical, plant steam, chillers, boilers, and emergency generators in the pilot plant.
2. Develops, implements and administers all of the facilities central utilities and preventative maintenance policies, processes and SOP’s.
3. Ensures pilot plant facility and operations are maintained in accordance with all CGMP, EMEA and JP requirements including industry safety standards and OSHA guidelines so that materials manufactured in the plant can be sued to support global clinical trials.
4. Makes minor repairs and inspections of equipment. Oversees major repairs of equipment by outside contractors. Makes sure all service and repairs are documents to global regulatory standards.
5. Troubleshooting of the BAS alarms as they relate to equipment and the buildings HVAC system. Monitors control alarms, and trends data from all of the critical systems and areas on site. May need to be available after hours to respond to alarms.
6. Monitors activities of outside contractors of the facility as well as for routine maintenance and repairs.
B.S. degree in engineering or related degree with a minimum of 10 years experience in facility management and engineering running a pilot plant facility. A PE certification is preferred but not required as well as experience building, commissioning and running a biologics manufacturing facility. Previous experience managing personnel highly preferred. Ability to recognize, assess and troubleshoot electrical, plumbing, and mechanical malfunctions, or equipment failures required.
• Ability to recognize, assess and troubleshoot electrical, plumbing, and mechanical malfunctions, or equipment failures required. Ability to make minor repairs to buildings and equipment and independently manage major repairs by an outside contractor.
• Must have excellent interpersonal and communication skills. Must be able to deal tactfully and courteously with fellow employees and venders/contractors.
• Thorough knowledge of the occupational hazards and corresponding safety precautions necessary for safe performance in using equipment to complete assigned tasks.
• Must be familiar with compliance requirements (cGMP, GLP, OSHA, CFR, etc.)
• Must be able to operate independently and recognize problem situations, inform his/her supervisor in a timely manner and address these problems in a timely manner so that the facility remains operational and can support Morphotek’s IND and clinical trial commitments.
• Must possess the ability to exercise sound judgment and decision-making, effectively plan and organize multiple tasks with high degree of complexity in order to complete them efficiently and in a timely manner.
Physical requirements
The employee must frequently lift and/or move up to 50 pounds and will frequently work with heavy equipment and in potentially hazardous situations such as with boilers, electrical generators and other high voltage equipment. Some work will also occur in the core manufacturing area so the ability to gown and follow cGMP manufacturing area practices is required.2420BRAdditionFull-time