Facilities Maintenance Manager
Summary: The Facilities Maintenance Manager, under the supervision of the Associate Director, Facilities Engineering, will be responsible for the engineering, operational and troubleshooting support for facilities, utilities and process equipment including but not limited to bioreactors, fermenters, incubators, filtration skids, chromatography skids, centrifuge, autoclaves, freezers, refrigerators, walk-in cold rooms, QC/PD lab equipment, air cooled chillers, air compressors and dryers, air handling units, MCRs, MBUs, steam boilers, water purification and distillation units, waste water treatment systems, etc. at the National Center for Therapeutic Manufacturing (NCTM), the Texas Biological Facility (TBF) and the Flexible Biological Facility FBF on behalf of Fujifilm Diosynth Biotechnology Texas (FDBT). This positon will also provide support during new facilities and equipment installation, working with the corresponding Calibration, Operations, Validation and Quality department personnel, and with the various contractors and consultants working on the projects. This position will work closely with Employee Health and Safety (EHS) to develop and ensure a safe workplace is developed; with Procurement for development of repair parts and spare parts strategies; and Calibration and Preventative Maintenance strategies for full facility operations when finished.
- Responsible for 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 conducting and evaluating training for new or existing equipment provided to operators and/or mechanics.
- Communicate easily with Contractors, Validation, Quality Assurance, Operations, Engineers, OEM providers, as well as internal equipment owners and operators, for successful management of the facilities department in 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.
- All other duties as may be assigned.
- Responsible for all Facilities/Utilities areas SOPs, PMs, JHA's.
- Responsible to support equipment IQ/OQ/PQ or any other validation startup activity as required.
Required Skills & Abilities:
- Strong understanding of GMP requirements for utility systems and clean room HVAC air pressure cascades and room changes.
- Must be able to generate Change Controls and perform Deviation investigations.
- 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 role 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 engineering Facilities Maintenance department 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.
- Bachelor's Degree preferably in Engineering, Maintenance, Bio-Engineering, or related field, and 5 years' experience in an engineering and maintenance role in a GMP or ISO certified facility; OR
- Associate's Degree preferably in Engineering such as Electrical, Chemical, Mechanical or Biomedical with four (10) years of experience in engineering and maintenance in an FDA regulated research or manufacturing facility; OR.
- Knowledge of preventative maintenance development through the use of a GMP Computerized Maintenance management System (CMMS) required.
- Previous Facilities Maintenance Manager role with 5 years of supervisor experience
- Supervise 8 or more employees.
- Experience with development of Technician training/qualification program
- Several years in a work scheduler or facilitator role highly desirable.
- A wide range of maintenance and trade experience is a plus, including mechanical systems, variable frequency drives, pumps, electric motors, gear reducers, manufacturing equipment maintenance and PLC Operations.
Salary: Starting salary will be commensurate with education and experience.
We are an equal opportunity and affirmative action employer. All qualified applicants will receive consideration without regard to race, color, national origin, sex, gender identity, sexual orientation, religion, disability, protected veteran status or any other characteristic protected by applicable federal, state or local law.