- Primary responsibility will be to learn to support other technicians in maintenance of the facility and equipment that supports Mobile Clean Rooms (MCRs) (independent clean rooms with redundant HVAC systems and controls), including qualified utility systems. Most maintenance activities will be scheduled and performed as much as possible when the MCRs are off-line, thus the ability to coordinate, communicate and plan are essential skills for this position.
- Provide maintenance support for other utility and MCR requirements, including clean utilities such as purified water systems, steam generated Water for Injection (USP), clean steam systems, clean rooms and environmental controlled areas. Technician will be trained on critical environment controls, GMP calibration, and maintenance on critical laboratory equipment.
- Able to work with operators and technicians in helping to perform troubleshooting or reliability tasks on other temperature controlled process equipment, such as bioreactors, centrifuges, micro-filtration skids.
- Ensure compliance, as set forth in internal quality protocols and SOPs including cGMP and FDA regulatory guidelines.
- Able to perform routine work orders and maintenance functions with little supervision after training and work in support of technicians or specialized maintenance contractors or OEM on more complex equipment interventions.
- Provide support and assistance to EH&S department in drafting SOPs, auditing facilities, etc.
- All other duties as may be assigned.
Required Skills & Abilities:
- Good mechanical and electrical skills. Understanding of proper tool use, and ability to work safely in and around equipment. Solid understanding of mechanical and electrical principles to be able to understand training on higher level system controls, and functions, understanding of refrigeration cycle, thermodynamics with respect to temperature control and automation, etc. Able to identify potential problem areas of equipment that is malfunctioning, using technical manuals or P&IDs.
- Strong written, verbal and interpersonal communications skills. Must be able to understand written communication and SOPs to execute preventative maintenance procedures or assist other technicians in the understanding technical equipment.
- Ability to learn quickly and work effectively with little supervision when needed.
- Experience with problem solving, able to think through a problem or equipment malfunction to arrive at key items to check.
- Working knowledge of MS Office products (Word, Excel, Outlook, PowerPoint).
- Experience in any additional maintenance trade highly desired (apprentice electrician, HVAC & R, boilers, pump maintenance, etc.)
- Knowledge of computerized instrumentation, micro-processor controlled operations, and micro measurement equipment is beneficial.
- Knowledge of bio-medical, bio-technical equipment, both upstream and downstream highly desirable.
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 be On-Call for maintenance issues in rotation with other technicians.
- Be exposed to outdoor weather conditions.
- Be exposed to noisy environments.
- Attendance is mandatory.
- Minimum High School Diploma, with some follow on technical education or training in a technical area in a College or University with a minimum of two (2) years’ work experience;
- Knowledge of electrical circuits, electrical distribution, Variable Frequency Drives, PLCs, or fundamentals of mechanics.
- Experience in a maintenance or mechanic role in a manufacturing facility.
- Understanding of clean room construction and basis of function.
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.