Process Maintenance Technician III
Company: FDBT - FUJIFILM Diosynth
Location: College Station
Posted on: January 12, 2021
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Job Description:
Overview Summary: The Process Maintenance Technician, under the
supervision of the Process Maintenance Supervisor will be the
individual primarily responsible for providing operational,
maintenance, and troubleshooting support for manufacturing process
areas equipment in support of both the Texas Biological Facility
(TBF) and the Flexible Biological Facility (FBF) on behalf of
Fujifilm Diosynth Biotechnology Texas (FDBT). Primary
responsibilities include ensuring safe and efficient hands-on
maintenance 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 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 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.External US Essential
Functions:* Responsible for providing operational, maintenance, and
troubleshooting support for manufacturing process areas equipment.*
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.* Assist with troubleshooting 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.* Be able to write or assist with SOPs, JHAs, HECPs and
preventive maintenance procedures for process equipment.* 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.*
Comply with Quality System requirements for Deviations and Change
Controls when required.* 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 mechanical, electrical and instrumentation
knowledge of equipment, using P&IDs, equipment manuals,
specifications, SOPs, and be able to use proper judgment when
taking corrective actions during equipment malfunctions.* 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.* 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
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 and
verbal communications skills, be self-motivated and possess
interpersonal skills.* Ability to learn quickly and work
effectively with little supervision when needed.* 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 mandatoryQualifications:* Associates
Degree in Engineering, Maintenance or Bio-Engineering, or related
field, with four (4) years' of relevant maintenance work experience
in bio-pharma facility with the above listed equipment; OR* High
School Diploma or GED with six (6) 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.Preferred Qualifications:* Experience
in other maintenance trades highly desirable. Example, experience
with RO/WFI Water, HVAC, Boilers, etc.
Keywords: FDBT - FUJIFILM Diosynth, College Station , Process Maintenance Technician III, Professions , College Station, Texas
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