The Maintenance Specialist participates in the day to day operation of cGMP compliant Facilities Dept. of the Center of Excellence for Regenerative Health Biotechnology (Florida Biologix) in Alachua, FL. Responsibilities include assisting the Facilities Manager in the day to day operation of the warehouse and in the maintenance, calibration, monitoring and possible repair of facility and manufacturing equipment and machinery. The specialist assists the Facilities Manager in all aspects of quality and FB standard operating procedures and cGMP compliance within the warehouse and regarding facility and equipment related activities.
All of the following work must be performed following written procedures and work must be documented concurrently, including equipment and material used. Immediately report all accidental deviations from procedures and document same. This position may require contact with human blood or other potentially infectious materials ( OPIM ) and Human Pathogen Research (BSL2+/BSL3):
Perform regular Preventative Maintenance as well as emergency maintenance on equipment within the facility on a monthly, quarterly, semi-annual or annual schedule. Work with outside contractors if needed.
Receive, label and record required information for all new equipment. Install or deliver new equipment to appropriate production area, laboratory or office. Calibrate new and existing equipment and systems. Document all activities performed including those by outside contractors per cGMP standards.
Assist in activities to maintain refrigeration, controlled heating, water systems, HVAC systems and facility equipment, machinery, buildings including written procedures for operation, maintenance, calibration and repair. Assist with troubleshooting and repairs of same.
Conduct activities when requested in the biological production facility according to written procedures requiring being fully gowned (hood, facemask, jump suit, booties, gloves, safety glasses) in compliance with cGMP regulations. Perform gowning qualification of outside vendors as required.
Perform other duties as assigned including receiving, shipping, inventory transport and issuance of materials used in the GMP facility. Maintain proper organization of warehouse and equipment. Re-stock materials as needed.
Completion of an approved apprenticeship program for multiple trades and one year of appropriate experience; or a high school diploma and five years of appropriate experience. Appropriate vocational/technical training may substitute at an equivalent rate for the required experience.