Facilities Maintenance Lead
The Maintenance Lead Technician, under the supervision of the Facilities Maintenance Manager will be responsible to lead the day-to-day aspects of operating and maintaining the facilities in support of the operation of the Texas Biological Facility (TBF), the Flexible Biological Facility (FBF), as well as the integration of the National Center for Therapeutic Manufacturing (NCTM) on behalf of Fujifilm Diosynth Biotechnology Texas (FDBT). The Facilities Maintenance Lead in support of the Facilities Maintenance Manager will be the lead maintenance and utility contact for covering the maintenance needs and with assigned personnel or contractors maintain the facility support equipment. This positon will also provide support for proper installation of new facilities support equipment, working with the corresponding calibration, operations and validation department personnel, and with the various contractors and consultants working on the projects. This position will work in support of the Facilities Manager and with Employee Health and Safety (EHS) to ensure a safe workplace is developed; and with Procurement for development of repair parts and spare parts strategies; and with Calibration manager as needed.
- Responsible for supporting the Facilities Maintenance Manager and taking a leadership role in the day to day operations of the maintenance group, able to handle multiple priorities quickly and efficiently and delegating tasks to appropriate trades and skill levels. This positon will also be responsible for scheduling and evaluating OEM and vendor training for new or existing equipment provided to operators and mechanics.
- This position will be on call for maintenance issues in rotation with other technicians.
- This position may require coverage of different shifts, weekends and holidays.
- Lead the technician team and assist during routine repair and maintenance functions with little supervision and to provide support to other technicians, specialized maintenance contractors or OEM on more complex equipment interventions.
- Perform daily work order activities per planning and scheduling.
- Lead troubleshooting efforts of Facilities Engineering and equipment issues including mechanical, electrical, instrumentation and automation as required.
- Ensure accurate documentation of maintenance activities such as PM, CM and emergency work orders through adherence of cGDPs.
- Responsible for developing, writing, editing and/or reviewing SOPs, JHAs, HECPs and operations/maintenance procedures.
- Comply with Quality System requirements for Deviations and Change Controls when required and ensuring team members are compliant with policies and regulations.
- Strict adherence to EH&S guidelines and policies required to ensure safely operation of the equipment and systems.
- Maintain all mandatory training requirements current, ensuring compliance to site procedures and job performance qualifications.
- Maintenance support to utility systems, including but not limited to air cooled chillers, air handlers, heating water and steam boilers, RO water purification skids, ultrapure water distillation units, clean steam generators, air compressors and dryers, waste water treatment systems, freezers, walk in cold rooms, temperature control units, etc. may be required.
- Other duties as assigned.
Required Skills & Abilities:
- Strong understanding of GMP requirements for utility systems and clean room HVAC air pressure cascades and room changes.
- Knowledge of a wide variety of typical maintenance tasks on systems including clean utilities and the tools and equipment required to perform many of the daily maintenance tasks.
- Strong written, verbal and interpersonal communications skills. Must be able to develop and draft clear procedures for operations and maintenance documentation.
- Desire to work in a fast paced, state of the art, alternately research and customized manufacturing facility.
- Ability to work quickly and effectively without constant supervision. Ability to supervise 8 to 10 skilled technicians in support of facility maintenance.
- Knowledge and understanding of OSHA regulations and safe work practices.
- Working knowledge of MS Office products (Word, Excel, Outlook, and PowerPoint) as well as use of Computerized Maintenance Management System, CMMS.
- This is a new role, and will require a high level of personal organizational skills, experience and drive. The successful candidate must have a vision of a final state, fully organized group of facility support technicians for a state of the art facility to operate in a highly regulated GMP environment.
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:
- Experience prolonged sitting, standing, walking, bending, stooping and stretching.
- Use hand-eye coordination and manual dexterity sufficient to operate portable tools, test instruments, as well as a computer keyboard, telephone, calculator, and other office equipment is required.
- Have a normal range of vision.
- The ability to regularly lift and/or move up to 50 pounds.
- Climb ladders and stairs of various heights.
- Be exposed to wet or humid conditions.
- This position may include On-Call response for Facility issues.
- Be exposed to outdoor weather conditions.
- Be exposed to noisy environments.
- Attendance is mandatory
- Associates Degree in Engineering, Maintenance or Bio-Engineering, or related field, with five (5) years' of relevant maintenance work experience in bio-pharma facility with the above listed equipment; OR
- High School Diploma or GED with seven (7) years' of relevant maintenance work experience in bio-pharma facility with the above listed equipment.
- Maintenance experience in a bio-pharma research, manufacturing facility or related industry.
- Experience with preventative maintenance development through the use of a GMP Computerized Maintenance management System (CMMS).
- Experience in other maintenance trades highly desirable. Example, experience with RO/WFI Water, HVAC, Boilers, etc.