Summary: The Process Maintenance Lead Technician, under the supervision of the Process Maintenance Supervisor will be the individual primarily responsible for providing operational, maintenance, monitoring, and troubleshooting support for manufacturing process areas equipment in support of both the Texas Biological Facility (TBF) and the Flexible Biological Facility FBF (TLVF) on behalf of Fujifilm Diosynth Biotechnology Texas (FDBT). The Process Maintenance Lead Technician will direct and coach other technicians and contractors ensuring safe, proper and efficient hands-on operation and maintenance, both routine and corrective of all process manufacturing equipment including but not limited to fermenters, bioreactors, tanks, chromatography columns, filtration skids, autoclaves, washers, centrifuges, mixers, agitators, and related support equipment such as pumps, fans, motors, valves, traps, etc. Maintenance activities would include troubleshooting, preventative and corrective interventions. 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. This position will be responsible for taking the lead in developing, changing and documenting maintenance procedures and training associates in the proper execution of these procedures. This position will work with other maintenance and technical trades, such as manufacturing operators, engineers, calibrations, validation and quality to help maintain these systems operational and in GMP condition. Strict adherence to Standard Operating Procedures (SOPs), cGMPs and Quality Standards in a Pharmaceutical Manufacturing facility are mandatory. The Process Maintenance Lead Technician will also be involved in the installation and connection of new process equipment on arrival and assist with any commissioning and qualification activity as required. This position will also work in support of the Environment, Health and Safety personnel (EHS) to ensure the systems are operated safely and within limits.
- Responsible for leading the day-to-day maintenance, and troubleshooting support of manufacturing process areas equipment.
- Responsible for monitoring the condition of the equipment to anticipate any future failure modes or conditions and recommending corrective actions.
- Able to perform routine repair and maintenance functions with little supervision and to provide support to other technicians, specialized maintenance contractors or OEM on more complex equipment interventions.
- Perform daily work order activities per planning and scheduling.
- Lead troubleshooting efforts of process equipment issues including mechanical, electrical, instrumentation and automation as required.
- Support process equipment IQ/OQ/PQ or any other validation startup activity as required.
- Ensure accurate documentation of maintenance activities such as PM, CM and emergency work orders through adherence of cGDPs.
- Support Reliability Centered Maintenance (RCM) activities including condition monitoring and predictive technologies as applicable.
- Understand and communicate with others regarding the condition of the systems and the possible effects of failure modes.
- Able to work with other manufacturing operators, engineers, validations and quality control personnel regarding changes or expansions to the system.
- Responsible for developing, writing, editing and/or reviewing SOPs, JHAs, HECPs and operations/maintenance procedures for process equipment.
- Comply with Quality System requirements for Deviations and Change Controls when required and ensuring team members are compliant with policies and regulations.
- Strict adherence to EH&S guidelines and policies required to ensure safely operation of the equipment and systems.
- Ensure compliance, as set forth in internal quality protocols and SOPs including cGMP and FDA regulatory guidelines, within the areas of responsibility.
- Maintain all mandatory training requirements current, ensuring compliance to site procedures and job performance qualifications.
- Demonstrate continuous personal pursuit to increasing job knowledge, proficiency in technical understanding, and problem solving abilities.
- Maintain a positive, professional, and customer oriented attitude.
- Communicate concerns related to safe work practices, hostile work environment, or any other type of employee misconduct directly to the Supervisor, Manager, or Human Resources.
- Maintenance support to other utility systems, including but not limited to air cooled chillers, air handlers, heating water and steam boilers, RO water purification skids, ultrapure water distillation units, clean steam generators, air compressors and dryers, waste water treatment systems, freezers, walk in cold rooms, temperature control units, etc. may be required.
- Other duties as assigned.
Required Skills & Abilities:
- Strong understanding of manufacturing process equipment and requirements with the ability to instruct and guide others on these requirements.
- Strong technical troubleshooting / problem solving skills. Possess or have the ability to gain knowledge with respect to the operation and maintenance of various process manufacturing systems and be able to transmit all this knowledge to other technicians and peers.
- Strong mechanical, electrical and instrumentation knowledge of equipment, using P&IDs, equipment manuals, specifications, SOPs, and be able to direct and coach other technicians in the use of proper judgment when taking corrective actions during equipment malfunctions.
- Knowledge of a wide variety of typical maintenance tasks, including PM, troubleshooting systemic problems such as pneumatic, mechanical, electrical, electronic and ladder logic programming. General principles of engineering, operations and maintaining process equipment and the tools and equipment required to perform many of the daily maintenance tasks.
- Knowledge of bio-medical, bio-technical equipment, both upstream and downstream highly desirable.
- Able to develop clear and correct maintenance procedures for technical/process equipment using the OEM manual and experience and training associates in the proper execution of these procedures.
- Possess or have the ability to gain knowledge of NFPA 70E requirements for safe work practices and be able to direct other technicians and contractors in such requirements.
- Possess or have the ability to gain knowledge of FDA, OSHA, EH&S, EPA, and state of Texas requirements and be able to direct other technicians and contractors in such requirements.
- Strong written and verbal communications skills, be self-motivated and possess interpersonal skills.
- Ability to work quickly and effectively without constant supervision. This is a working lead positon.
- Desire to work in a fast paced, state of the art, alternately research and customized manufacturing facility.
- Working knowledge of MS Office products (Word, Excel, Outlook, and PowerPoint) as well as use of Computerized Maintenance Management System, CMMS.
- Knowledge of cGMP and cGDP requirements and procedures predisposed to documentation of work performed, documenting non-conformance conditions and maintaining clean work areas.
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 include On-Call response for Facility issues.
- Be exposed to outdoor weather conditions.
- Be exposed to noisy environments.
- Attendance is mandatory
- Associates Degree in Engineering, Maintenance or Bio-Engineering, or related field, with five (5) years’ of relevant maintenance work experience in bio-pharma facility with the above listed equipment; OR
- High School Diploma or GED with seven (7) years’ of relevant maintenance work experience in bio-pharma facility with the above listed equipment.
- Maintenance experience in a bio-pharma research, manufacturing facility or related industry, with emphasis on process equipment is a must.
- Experience with preventative maintenance development through the use of a GMP Computerized Maintenance management System (CMMS).
- Experience in other maintenance trades highly desirable. Example, experience with RO/WFI Water, HVAC, Boilers, etc.
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.
If an accommodation to the application process is needed, please e-mail FDBTHR@fujifilm.com or call 979-431-3528.