Facility Engineering – Director
College Station, Texas
- Provides oversight in overall building operations including preventative maintenance, supply chain control, change-over and utilization of the various manufacturing platforms.
- Independently evaluates, selects, and applies standard engineering techniques, procedures, and criteria, using judgment in making adaptations and modifications.
- Responsible for facility services, maintenance, and the design, installation and maintenance of facility systems (HVAC, DI/RO water, WFI, clean steam, electrical, compressed air, back-up power, etc). Coordinates work of contractors to maintain facility and systems.
- Directs Metrology and Calibration.
- Inspects the progress of any building construction and modification and/or equipment installation to current FDBT and GMP standards.
- Prepares system layout and detailed drawings and schematics. Analyzes test data and reports to determine if design meets functional and performance specifications.
- Ensures proper operation of systems in compliance with required regulations and codes.
- Evaluates operation of equipment through use of instrumentation.
- Provides troubleshooting of the facility infrastructure and production equipment to support facility operations.
- Initiates planned maintenance programs for all facility equipment.
- Oversees Parking Program.
- Oversees housekeeping and Maintenance of Facilities.
- Develops and administers annual departmental budgets.
- Anticipates future demands for facility maintenance resources and screens and hires staff to support those needs.
- Provides staff development and training for operations personnel in the function of facility equipment.
- Develops operating budgets including capital requirements to improve productivity.
- Advises management of new developments which may affect profit, schedule, costs, customer relations, and/or inter-departmental relations.
- Works closely with Texas A&M maintenance and support staff for support of the NCTM.
- Other duties as assigned.
Required Skills & Abilities:
- Extensive Knowledge of engineering principles, practices, theories and technologies related to equipment controls, mechanical or electrical/electronic systems and processes
- Knowledge and understanding of the techniques and procedures of engineering project management as well as OSHA regulations and safe work practices
- This position coordinates and communicates with other departments using complex biological and scientific processes and equipment. This position requires strong communication skills and must be well versed in bio-tech industry.
- Thorough understanding of FDA GMP requirements with experience in quality audits and FDA audits.
- Skill in use of word processing software, spreadsheet software, and other systems as required
- Must have experience working in the following areas:
- HVAC Systems supplying controlled conditioned air to clean room and non-clean room environments for containment and elimination of cross contamination.
- Process Chilled Water system
- Water Systems (RODI, Purified, or Water For Injection Systems, multiple buildings)
- Building Automation/Monitoring and Control Systems
- Building Security/Access Systems
- Instrument/Process Air Systems
- Waste Inactivation and Neutralization Systems
- Drafting and implementing Standard Operating Procedures for maintenance, pest control, metrology and other facility functions.
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 a keyboard, photocopier, telephone, calculator, and other office equipment is required.
- The ability to regularly lift and/or move up to 10 pounds and occasionally lift and/or move up to 50 pounds.
- Climb ladders and stairs of various heights.
- Be exposed to wet or humid conditions.
- Be exposed to outdoor weather conditions.
- Be exposed to noisy environments.
- Attendance is mandatory.
- Requires a minimum of a Bachelor of Science in Engineering with at least 10 years of experience working in cGMP clinical or licensed manufacturing facility.
- At least 5 years of experience in a supervisory/management role.
- Master of Science in Engineering.
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.
If an accommodation to the application process is needed, please e-mail FDBTHR@fujifilm.com or call 979-431-3528.