|Date Posted||July 18, 2021|
Trades & Services
The Facilities Maintenance Supervisor, under the supervision of the Facilities Maintenance Manager, will be responsible for 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 Supervisor 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 vender training for new or existing equipment provided to operators and mechanics.
- Work could require night shift coverage.
- Communicate easily with Contractors, engineers, OEM providers as well as internal equipment owners and operators for successful turnover of the facility to FDBT.
- Ensure compliance, as set forth in internal quality protocols and SOPs including cGMP and FDA regulatory guidelines, within the areas of responsibility.
- Able to work with other engineers and validation contractors in directing and providing oversight of specialized contractors to ensure facility and equipment are delivered and/or maintained as proscribed.
- Assist with writing job descriptions, interviewing and hiring the personnel needed to support the maintenance tasks for the facility.
- All other duties as may be 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 will 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, and 3 years' experience in an engineering and maintenance role in a GMO or ISO certified facility, with several years' work in a scheduler or facilitator role highly desirable; OR,
- Some college course work in Engineering, Maintenance, Bio-Engineering, or related field or Technical Training, or Certifications or Trade Licensing and 7 years' experience in engineering, facility or maintenance.
- Knowledge of preventative maintenance development through the use of a GMP Computerized Maintenance Management System (CMMS) required.
- Experience in training mechanics or trades. Some subordinate mechanics may have little experience in some types of equipment installed in this facility, training will be required.
- Prefer some or all experience in the biopharma industry.
- A wide range of maintenance and trade experience is a plus, including mechanical systems, frequency drives, pumps, electric motors, gear reducers and PLC Operations.