Engineering - Manager (Process Engineer)
Company: FUJIFILM Holdings America Corporation
Location: College Station
Posted on: September 6, 2023
Job Description:
Engineering - Manager (Process Engineer)
Job Locations
US-TX-College Station
Requisition ID
2023-23892
Category
Engineering
Company (Portal Searching)
FUJIFILM Diosynth Biotechnologies
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 Process Engineering Manager, under the
supervision of the Director of Engineering, will be responsible for
leading a team and overseeing process engineering activities such
as new equipment/systems installation, new products introduction
support, infrastructure assessments, system capability 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
provide guidance on 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 Functions:
Lead process engineering staff on the
implementation of process equipment, site utilities and new
technologies.Provide oversight of engineering activities,
troubleshooting support and technical expertise for process
equipment and site utilities.Facilitates technology and
manufacturing program development in support of specific client and
market opportunities.Lead new product introductions (NPIs) from the
infrastructure and process equipment point of view.Support client,
quality and regulatory audits and inspections.Lead and manage new
equipment/systems installation including infrastructure,
connectivity and capability assessments.Lead the implementation of
solutions to engineering problems and/or opportunities and apply
technical expertise to develop and present feasible solutions.Lead
and train engineering staff in the development of change controls
for the implementation of new system/equipment installations,
process improvements, site utilities among others.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.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 projects.Mentor and develop engineering
staff on process/utilities equipment and new technologies.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.Lead the development, edit and/or review
in collaboration with Facilities SOPs, P&IDs and maintenance
procedures for new equipment and/or systems.Communicate efficiently
with management, 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:
Knowledge of engineering principles,
practices, theories and technologies related to equipment controls,
mechanical or electrical/electronic systems and processes.Knowledge
and understanding of the techniques and procedures of engineering
project management as well as OSHA regulations and safe work
practices.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 skills.Must be flexible and able to
manage multiple priorities and tasks.Must be results driven and
goal oriented with the ability to manage risks.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 malfunctioning.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).Knowledge of regulatory requirements for manufacturing
of pharmaceutical products.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 management.Be self-starter,
self-motivated, detail oriented 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 off shifts,
weekends and/or holidays support. Be exposed to outdoor weather
conditions.Be exposed to noisy environments.Attendance is
MandatoryMinimum Qualifications:
Bachelor's Degree preferably in
Electrical, Chemical, Mechanical or Biomedical Engineering Ten (10)
years of qualified experience in an engineering role in an FDA
regulated research or manufacturing facility plus at least three
(3) years of managerial experience. Preferred Qualifications:
Knowledge of bio-processing
equipment, clean utilities, and single use equipmentKnowledge of
quality management software specifically Trackwise 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.
Keywords: FUJIFILM Holdings America Corporation, College Station , Engineering - Manager (Process Engineer), Executive , College Station, Texas
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