Facilities Maintenance Technician II

Overview

Follow Your Genki to FUJIFILM Diosynth Biotechnologies (FDB)

 

The work we do at FDB has never been more important—and we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people’s lives. Join FDB and help create the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe. We are proud to cultivate a culture that will fuel your passion, energy and drive - what FDB call Genki.

 

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 second shift position after an appropriate training period.

External US

Essential Functions:

 

• 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 commun