The primary responsibilities of this position are to provide supervision during the construction of a new cGMP manufacturing operation and, upon completion of the construction, to ensure that the building, utility equipment, office environments, manufacturing and laboratory support systems consistently perform as designed. The Facilities Supervisor acts as a key liason 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.
Partner with the project team, including facilities, engineering, EH&S, the general contractor, the engineering firm and equipment vendors to ensure that the manufacturing facility is constructed in accordance with the plans and specification to deliver a facility that is safe, reliable and maintainable.
Lead the construction effort on a daily basis and take full accountability for the project site ensuring coordination of all construction site activities, including safety meetings, field inspections, test witnessing, material verification, etc.
Act as the primary facilities representative to the construction project with responsibility for preparation and/or approval of site announcements, action notifications, CMMS records, hot work permits, line break permits, maintenance plans, maintenance SOPs, etc.
Must poses thorough knowledge of clean room mechanical systems, maintenance practices, and certification processes. Understands common engineering controls utilized to inhibit microbiological growth and product contamination.
Creates, modifies, and reviews cGMP documentation to ensure compliance to all applicable governing bodies.
Takes part in and leads Quality Incident Investigations. Develops effective CAPAs and completes assigned CAPAs completely and on time.
Organize, author and manage both Engineering Change Management and Quality Change Control activities with input from a cross functional project team. Develop robust Change Control strategies and change control plans and manage implementation to ensure effective change management and risk mitigation.
Drives proper cGMP documentation practices and CMMS data quality. Utilizes system to manage internal and external resources according to established workflows.
Develops and utilizes key performance indicators associated with equipment reliability, resource efficiency and utilization, PM compliance, and backlog to drive performance and continues improvement.
Working hours: 8:00 AM - 5:00 PM
BS degree or equivalent experience, Mechanical Engineering degree preferred.
Proven 5-7 years experience in a GMP Facility in a technical role. Mastery of cGMPs and regulatory requirements is required.
Requires in depth knowledge of cGMPs as they relate to facilities maintenance to ensure processes and facilities are compliant and changes are consistent with necessary controls.
Experience with large capital projects involving process and utilities equipment in cGMP environments.
Experience with Micorsoft Office Suite, Maximo, MS Project and Procore.
In depth trades experience required, professional licensing preferred.
Demonstrated skills in leadership, communication, teamwork, and change management.
Experience managing direct reports, indirect reports and outside service providers.
On call support and weekend work may be required to support project and manufacturing operations.
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