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PCI
Bedford, NH, USA; USA_NH_Bedford_14Ind
Source: PCI careers · View original posting
From PCI's posting. “We” and “our” refer to the employer.
Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.
We are PCI.
Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
Reporting To: Facilities Manager/Senior Mgr.
Responsible For (Staff): No
The Facilities Supervisor is the key liaison to the facilities department to ensure that installed systems meet all applicable codes and standards, support cGMP manufacturing operations and are maintained in accordance with a well-established preventative maintenance program.
The Facilities Supervisor’s primary responsibilities are to support facilities management in planning, maintaining, scheduling, implementing best practices, improving and promoting safety for the Facilities, Systems, Utilities and Equipment (FSUE). The incumbent supervises the GMP maintenance staff and will be responsible for execution of the day-to-day maintenance ensuring use-ready and compliant facilities and utilities, including timely completion of preventative maintenance, troubleshooting, and repairs to maintain (FSUE) in an
operational state compliant with regulatory requirements for a GMP environment. Responsible for driving the PCI culture through values inclusive of customer service standards. Accountable for outstanding customer service to all external and internal functional teams.
Promote safety rules and awareness. Always demonstrates good safety practices including the appropriate use of protective equipment. Reports and takes initiative to correct safety & environmental hazards.
Responsible for supervision of maintenance and Facilities activities for 24/7 GMP operations.
Trains junior staff in facilities maintenance trades and safety procedures; assists management to determine training needs for the team.
Travels between facilities to support all functional areas
Establish all required preventive maintenance plans utilizing the Regulatory Asset Manager (RAM) System.
Ensure preventive maintenance work plans are current, accurate, written with sufficient detail, and executed
Provide long term solutions and day-to-day support to all operating teams having issues with troubleshooting, problem analysis, equipment failures, etc.
Generate, revise and review cGMP documentation to ensure compliance to all applicable governing bodies.
Support Quality Incident Investigations, CAPAs and ensure completion of assigned CAPAs completely on time.
In collaboration with Facility Manager, ensure technicians are adequately trained on site facility and systems
Schedule and coordinate shutdowns to include preventative maintenance, projects, and facility modifications.
In collaboration with Facilities Manager, prioritize and plan work activities for maintenance technicians; use time efficiently; develop realistic action plans. Work closely with other cross functional support groups
Supervise assets and spare part usage for manufacturing equipment and make changes to improve cost and efficiency.
Support the implementation and supervision of predictive, corrective and preventive maintenance to meet GMPs.
Organize, review, prioritize, and schedule daily Maintenance Work Orders (MWO) and Preventative Maintenance (PM) work. Efficiently coordinate the workflow and documentation of PMs and WOs.
Monitor and report equipment performance and efficiency data and identify any trending. Using data analysis, troubleshoot and determine root cause of equipment failures and develop solutions to prevent future failures.
Drive proper cGMP documentation practices and data quality. Utilizes system to manage internal and external resources according to established workflows.
Ensure that all areas and equipment are maintained in Good Housekeeping condition and facilities are always in inspection/audit ready states.
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