Facilities Engineer I
Company: FDBT - FUJIFILM Diosynth
Location: College Station
Posted on: January 12, 2021
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Job Description:
Overview Summary: The Facilities Engineer I, under the
supervision of the Associate Director, Facility Engineering, will
be responsible for performing various aspects of engineering,
operational and troubleshooting support for facilities, utilities
and process equipment including but not limited to bioreactors,
fermenters, incubators, filtration skids, chromatography skids,
centrifuge, autoclaves, freezers, refrigerators, walk-in cold
rooms, QC/PD lab equipment, air cooled chillers, air compressors
and dryers, air handling units, MCRs, MBUs, steam boilers, water
purification and distillation units, waste water treatment systems,
etc. at the National Center for Therapeutic Manufacturing (NCTM),
the Texas Biological Facility (TBF) and the Flexible Biological
Facility FBF on behalf of Fujifilm Diosynth Biotechnology Texas
(FDBT). This position will apply engineering principles to monitor
the running condition of complex equipment, and use technical
manuals, on-line resources and OEM representatives to maintain the
equipment with a minimum of downtime. This position will also work
closely with manufacturing resources, validation, QA/QC and
maintenance/calibration technicians to help maintain complex
process equipment operational and troubleshoot to identify issues
when needed. This position will require involvement in the
utilities and production processes to identify and implement
process improvements using Change Control procedures as well as
perform corrective and preventive actions using the CAPA system.
This position will also support P&ID development, maintenance
strategies development, equipment life cycle development, any
software and/or hardware upgrades and equipment
commissioning/qualification activities as required. This position
may also assist in the identification of equipment of the proper
type, size, materials, throughput, physical dimensions, required
utilities and URS development for future projects. External US
Essential Functions:* Responsible for providing engineering,
operational and troubleshooting support to facilities, utilities
and process equipment as needed.* Responsible for monitoring
complex equipment and maintaining the equipment with a minimum of
downtime. * Responsible for developing, writing, editing and/or
reviewing SOPs, JHAs, HECPs, P&IDs and operations/maintenance
procedures for facilities, utilities and process equipment.*
Responsible for the implementation of process improvements and
corrective actions as well as the development of maintenance
strategies and equipment life cycle.* Responsible to support
equipment IQ/OQ/PQ or any other validation startup activity as
required.* Responsible to support Reliability Centered Maintenance
(RCM) activities including condition monitoring and predictive
technologies as applicable.* Communicate efficiently with
Contractors, Suppliers, OEM providers as well as internal equipment
owners and operators for a successful operation of the FDBT
facility. * Able to work with other contractors, manufacturing,
validations and quality control personnel regarding changes or
improvements to the systems.* Ensure compliance, as set forth in
internal quality protocols and SOPs including cGMP and FDA
regulatory guidelines, within the areas of responsibility, and
document out of specification conditions with deviations, CAPAs and
Change Controls as appropriate.* Continuously stay current with
assigned SOPs and keep up to date training file ensuring compliance
with all applicable Standard Operating Procedures.* Ensure a safe
work environment is maintained through adherence and compliance
with safety guidelines, policies, 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.* All other
duties as assigned.Required Skills & Abilities:* Able to identify
potential problem areas of equipment that is malfunctioning, using
technical manuals or mechanical, electrical or controls knowledge.*
Knowledge and understanding using P&IDs, equipment manuals,
specifications, SOPs, and be able to use proper judgment when
taking corrective actions during equipment malfunctions.* Strong
analytical and problem solving skills. Possess or have the ability
to apply these skills to resolve technical problems and to gain
knowledge with respect to the operation and maintenance of various
utility/process systems.* Must be able to develop, and draft
operational procedures and maintenance procedures for technical
(utilities/process) equipment using the OEM manual and system
knowledge.* Possess or have the ability to gain knowledge of FDA,
OSHA, EH&S, EPA, and state of Texas requirements.* Must be able
to use project management software such as Microsoft Project.
Proficient with MS Office products (Word, Excel, Outlook,
PowerPoint).* 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.* Knowledge of
bio-medical, bio-technical equipment, both upstream and downstream
highly desirable. * All other duties as assigned.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 require On-Call and/or off shift support/response
for maintenance issues.* Be exposed to outdoor weather conditions.*
Be exposed to noisy environments.* Attendance is
MandatoryQualifications:* Bachelor's Degree preferably in
Engineering such as Electrical, Chemical, Mechanical or Biomedical
with one (1) year of experience in engineering and maintenance in
an FDA regulated research or manufacturing facility; OR*
Associate's Degree preferably in Engineering such as Electrical,
Chemical, Mechanical or Biomedical with two (2) years of experience
in engineering and maintenance in an FDA regulated research or
manufacturing facility; OR * High School Diploma with at least one
year of education or training in a college or university plus four
(4) years of relevant engineering work experience in a bio-pharma
research, manufacturing facility or related industry with the above
listed equipment. Salary: Starting salary will be commensurate with
education and experience.
Keywords: FDBT - FUJIFILM Diosynth, College Station , Facilities Engineer I, Other , College Station, Texas
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