Summary: The Process Maintenance Lead Technician, under the supervision of the Process Maintenance Supervisor will be the individual primarily responsible for providing operational, maintenance, monitoring, and troubleshooting support for manufacturing process areas equipment in support of both the Texas Biological Facility (TBF) and the Flexible Biological Facility FBF (TLVF) on behalf of Fujifilm Diosynth Biotechnology Texas (FDBT). The Process Maintenance Lead Technician will direct and coach other technicians and contractors ensuring safe, proper and efficient hands-on operation and maintenance, both routine and corrective of all process manufacturing equipment including but not limited to fermenters, bioreactors, tanks, chromatography columns, filtration skids, autoclaves, washers, centrifuges, mixers, agitators, and related support equipment such as pumps, fans, motors, valves, traps, etc. Maintenance activities would include troubleshooting, preventative and corrective interventions. This position will be required to use technical manuals, on-line resources and OEM representatives to maintain the equipment operational with a minimum of downtime. This position will be responsible for taking the lead in developing, changing and documenting maintenance procedures and training associates in the proper execution of these procedures. This position will work with other maintenance and technical trades, such as manufacturing operators, engineers, calibrations, validation and quality to help maintain these systems operational and in GMP condition. Strict adherence to Standard Operating Procedures (SOPs), cGMPs and Quality Standards in a Pharmaceutical Manufacturing facility are mandatory. The Process Maintenance Lead Technician will also be involved in the installation and connection of new process equipment on arrival and assist with any commissioning and qualification activity as required. This position will also work in support of the Environment, Health and Safety personnel (EHS) to ensure the systems are operated safely and within limits.
Required Skills & Abilities:
Working Conditions & Physical Requirements:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to: