The Metrology/Validation Manager oversees and participates in the day-to-day operations of the Florida Biologix Facilities Department which is part of the Center of Excellence for Regenerative Health Biotechnology. The duties include supervision and training of staff responsible for the receipt and handling of new equipment as well as maintenance, calibration, validation, monitoring and repair of building facility, manufacturing equipment and machinery. In addition the manager will oversee the transfer of equipment to other departments, H2O2 fumigation of production modules and the shipping of equipment as required. The Florida Biologix facility is operated in compliance with cGMP regulations, and this position includes responsibility for ensuring compliance with these regulations. This position is located in Alachua, Florida.
Supervise staff and participate in the validation (IQ/OQ/PQ) of new equipment and the revalidation of current equipment. This includes autoclave validation, revalidation of 350 square foot cold room, ultra-low temperature freezers and other temperature controlled equipment. This position also requires the generation, execution and review of the Validation protocols required to complete this work. Supervise staff and participate in the regular Preventative Maintenance as well as emergency maintenance of equipment within the facility on a monthly, quarterly, semi-annual or annual schedule. Working with outside contractors if needed. Supervise staff and participate in the performance of equipment receipt, labeling and data entry required. Delivery and installation of new equipment to the appropriate production areas, laboratories or offices. Supervise staff and participate in the coordination of laboratory equipment calibration activities, including the calibration of new and existing equipment and systems. This person organizes calibration activities with outside calibration vendors and manufacturing, Quality Control, PD and facilities personnel in order to ensure they are conducted in a timely, efficient, and productive manner compliant with cGMPs, internal quality systems and procedures, as well as project requirements and timeline. This person is also responsible for providing Facilities review of calibration certificates and qualifications performed by outside vendors. Supervise staff and participate in routine cleaning of the manufacturing plant including scheduling the completion of major and partial cleaning of equipment in the classified cleanroom areas (including process equipment and temperature controlled equipment), warehouses and the mechanical rooms allowing equipment and production modules to be ready for use on a daily basis. Supervise staff responsible for performing daily monitoring of equipment such as temperature monitoring equipment (chart recorders including changing chart paper), GMP and waste autoclave, incubators, ultra-low temperature freezers, LN2 and other freezers and refrigerators. Reviews, writes and revises standard operating procedures, forms and other controlled documents to perform all facilities-related functions. Reviews data or documentation generated as a result of these procedures. Ensures that documentation of repairs, adjustments, and replacement of equipment and/or components for South building is performed in accordance with cGMP regulations. Ensures that all required documentation and records are maintained or archived in QA as appropriate. Ensures the maintenance of facility electronic databases, contact lists, schedules, etc. Assist with maintaining the function and professional appearance of non-manufacturing areas such as warehouse areas, office space, other laboratories (e.g. QC and Process Development), and the Education Center. Other duties as assigned.
Monday through Friday, 8:00 AM to 5:00 PM
Evenings, weekends and/or holidays as needed to complete work and/or to follow SOPs. On call work is required up to 25% of that required by Facilities department.
A bachelor’s degree in an appropriate area of specialization; or a high school diploma and four years of appropriate experience.
Appropriate college coursework or vocational/technical training may substitute at an equivalent rate for the required experience.
This is a time limited position.
Bachelor’s Degree in Electrical or Mechanical Engineering, or Biology
5+ years management experience in Biotech Facilities Maintenance and Engineering
Knowledge of Quality Management systems ( ISO 9001, ISO 17025 and ANSI Z540)
Expert ability to troubleshoot repair, align and optimize precision equipment
Health Assessment Required:
Special instructions to applicants:
Post offer health assessment is required heavy lifting must be able to lift up to 50 lbs, respirator and contact with human blood or other potentially infectious material ( OPIM ).