Summary: The Maintenance Technician II, under the supervision of the Facilities Maintenance Supervisor, or designated supervisor will be responsible for performing various aspects of utilities, facilities and process equipment maintenance and support for the Texas Biological Facility (TBF), the Flexible Biological Facility (FBF) and the National Center for Therapeutic Manufacturing (NCTM) on behalf of Fujifilm Diosynth Biotechnology Texas (FDBT).
Primary responsibilities include various aspects of maintenance and support for facilities, utility equipment and biotech processing equipment.
This position will be required to use technical manuals, on-line resources and OEM representatives to maintain the equipment operational with a minimum of downtime. Strict adherence to Standard Operating Procedures (SOPs), cGMPs and Quality Standards in a Pharmaceutical Manufacturing facility are mandatory.
This position is for a night shift position after an appropriate training period.
- Provide maintenance, reliability and operational support for clean utility equipment, including clean utilities such as clean gases, steam generated Water for Injection (USP), clean steam systems, and RODI water systems.
- Provide maintenance, reliability and operational support for plant utility equipment, including utilities such as air compressors, air dryers, steam boilers, chillers, heating hot water boilers, HVAC systems and waste disposal systems.
- Provide maintenance, reliability and operational support for fermenters, bioreactors, tanks, chromatography columns, filtration skids, centrifuges, autoclaves, agitators, etc. in coordination with manufacturing operators or supporting departments.
- Provide maintenance and operational support for facilities, building maintenance and grounds.
- Technician will be responsible for critical environment controls, maintenance on critical laboratory equipment within GMP clean rooms and environmental controlled areas.
- Able to perform troubleshooting or reliability tasks on temperature controlled process equipment such as refrigerators, freezers, ultra-low temperature freezers and cold rooms.
- 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.
- Able to work with other contractors, engineers, validations and quality control personnel regarding changes or improvements to the systems.
- Be able to write or assist with SOPs, JHAs, HECPs and preventive maintenance procedures for utilities equipment.
- Maintain all mandatory training requirements current, ensuring compliance to site procedures and job performance qualifications.
- Demonstrate continuous personal pursuit to increasing job knowledge and proficiency with different systems.
- Maintain a positive, professional, and customer-oriented attitude.
- All other duties as may be assigned.
Required Skills & Abilities:
- Understanding of proper tool use, and ability to work safely in and around equipment.
- Advanced knowledge of mechanical and electrical principles.
- Advanced mechanical skills and knowledge of a majority of the systems listed in the Essential Functions.
- Able to identify potential problem areas of equipment that is malfunctioning, using technical manuals or P&IDs.
- Able to develop clear and correct maintenance procedures for technical/utility equipment using the OEM manual and some system knowledge.
- Possess or have the ability to gain knowledge of NFPA 70E requirements for safe work practices.
- Possess or have the ability to gain knowledge of FDA, OSHA, EH&S, EPA, and state of Texas requirements.
- 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).
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.
- Be exposed to outdoor weather conditions.
- Be exposed to noisy environments.
- Attendance is mandatory.
- 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.
- High School Diploma or GED with four (4) years of relevant maintenance work experience in bio-pharma facility with the above listed equipment.
- Associates Degree in Engineering, Maintenance or Bio-Engineering, or related field, with two (2) years of relevant maintenance work experience in bio-pharma facility with the above listed equipment; OR
- Maintenance experience in a bio-pharma research, manufacturing facility or related industry.
- Experience in a maintenanc
- e or mechanic role in a manufacturing facility.
- Understanding of clean room construction and basis of function with experience in a bio-pharma research, manufacturing facility or related industry with the above listed equipment.
- Experience in any additional maintenance trade highly desired (apprentice electrician, HVACR, boilers, pump maintenance, etc.)
- Knowledge of computerized instrumentation, microprocessor controlled operations, and micro measurement equipment is beneficial.
- Knowledge of bio-medical, bio-technical equipment, both upstream and downstream desirable.
Salary: Starting salary will be commensurate with education and experience.
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