Company: FUJIFILM Holdings America Corporation
Location: College Station
Posted on: June 17, 2022
Overview Summary: - The Process Engineer, under the supervision
of the Director of Engineering, will be responsible for performing
engineering activities, new equipment/systems installation, new
products introduction support, infrastructure assessments,
troubleshooting support and technical expertise for process
equipment and site utilities on behalf of the different facilities
at Fujifilm Diosynth Biotechnology Texas (FDBT). Equipment support
includes bioreactors, 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/water
boilers, water purification and distillation units, wastewater
treatment systems, among others. This position will work closely
with facilities, manufacturing resources, CAPEX team, validation,
QA/QC and contractors to perform projects implementation and to
help maintain complex process equipment and site utilities. 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,
SOP's development and equipment commissioning/qualification
activities as required. This position will also lead the
identification of equipment of the proper type, size, materials,
throughput, physical dimensions, required utilities and URS
development for future projects. - - External US Essential
- Provide engineering, troubleshooting support and technical
expertise for process equipment and site utilities as needed.
- Proactively identify engineering problems or opportunities and
apply technical expertise to develop and present feasible
- Lead and manage new equipment/systems installation including
infrastructure, connectivity and capacity assessments.
- Lead and manage process improvements, corrective and preventive
actions (CAPAs) and change controls implementation for process
equipment and site utilities.
- Lead the identification of new equipment including but not
limited to proper type, size, materials of construction,
throughput, operational conditions, physical dimensions, required
utilities, waste requirements, user requirements specifications
(URS) and others.
- Support new product introductions (NPIs).
- Work with process sciences in developing new
equipment/systems/process design, controls, requirements,
specifications and drawings.
- Liaison with CAPEX team for the implementation of capital
- Coordinate execution of projects, improvements and other
- Oversee contractors when implementation and/or corrections are
- Works with QA/QC to ensure proper testing, inspection and
release after completion of engineering activities.
- Support equipment IQ/OQ/PQ or any other
validation/commissioning startup activity as required.
- Ensure new equipment operates in compliance with required EHS,
regulations and codes.
- Develop, write, edit and/or review in collaboration with
Facilities SOPs, P&IDs and maintenance procedures for new
equipment and/or systems.
- 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
- 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
- Continuously stay current with assigned SOPs and keep up to
date training file ensuring compliance with all applicable Standard
- 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
- Maintain a positive, professional, and customer-oriented
- 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.
- Demonstrate leadership, technical aptitude, and problem-solving
- Must be flexible and able to manage multiple priorities and
- Must be results driven and goal oriented with the ability to
- Knowledge and understanding using P&IDs, equipment manuals,
specifications, SOPs, and be able to use proper judgment when
implementing projects or taking corrective actions during equipment
- 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,
- Knowledge of regulatory requirements for manufacturing of
- Strong written and verbal communications skills with the
ability to effectively communicate within cross-functional teams
and to upper management.
- Ability to organize and present technical overviews to
engineering staff, cross functional departments, and upper
- Be self-starter, self-motivated, detail oriented and possess
- 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
- 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 off shifts, weekends and/or holidays
- Be exposed to outdoor weather conditions.
- Be exposed to noisy environments.
- Attendance is Mandatory -Minimum Qualifications:
- Bachelor's Degree preferably in Electrical, Chemical,
Mechanical or Biomedical Engineering
- Six (6) years of qualified experience in an engineering role in
an FDA regulated research or manufacturing facilityPreferred
- Knowledge of bio-processing equipment, clean utilities, and
single use equipment
- Knowledge of quality management software specifically
TrackwiseSalary: - 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 979-431-3500.
Keywords: FUJIFILM Holdings America Corporation, College Station , Process Engineer, Engineering , College Station, Texas
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