Manufacturing Associate Process Engineer
Company: FDBT - FUJIFILM Diosynth
Location: College Station
Posted on: November 23, 2021
Overview Summary: The Manufacturing Associate Process Engineer
is an integral part of the Manufacturing Technical Operations
department, supporting Gene Therapy manufacturing at the National
Center for Therapeutics Manufacturing (NCTM) and the Flexible
Bio-Manufacturing Facility (FBF200), located in College Station,
Texas.-- This position will report directly to the Manager of
Technical Operations, Gene Therapy Manufacturing.Works
independently, and with colleagues, to provide expertise and
assistance for the design, development, standardization and
maintenance of an operational biotechnology utilized in the
manufacture of a variety of gene therapy, protein, and other types
of drug substances.-- This person would become the subject matter
expert on core manufacturing and operational technologies for the
manufacturing unit.-- Operational biotechnologies include:--
Isolators and biosafety cabinets and their use in cell propagation,
Cell Culture/Single Use Technology for adherent and suspension
culture, Dispensing and Mixing and Buffer Preparation,
Chromatography, Tangential Flow Filtration, various filtration
technologies, cCentrifugation, and Bulk Fill.-- This position will
also create training programs and perform training for
manufacturing technicians in the unit operation categories.
External US Essential Functions:Develop and maintain equipment and
unit operation standards and procedures utilizing 4M (Man,
Materials, Machinery and Methods) approach including:
- Support new equipment purchasing, URS creation and or revision,
equipment qualification and procedure creation and or
- Creation and or revision of recipe or methods for various
- Review and/or Approve equipment qualification limits.
- Review Calibration Tolerances and Approve Out of Tolerance
- Develop and approve procedures for new equipment being
introduced into the plant.
- Support new product transfer by creation or revision of the
Process Consumable List
- Create and or revise item specifications packages, work with
vendors in obtaining required documentation to support item
specifications and development of new drawings in support of item
specifications.Required Skills & Abilities:
- Excellent oral and written communication skills, interpersonal
and organizational skills.
- Strong leadership skills.
- Ability to train others to perform to cGMP standards.
- Proficient with Microsoft Office applications.
- Good self-discipline and attention to detail; ability to work
under minimal supervision.
- Must have flexible work hours --- must be willing to work
outside of normally-scheduled hours as necessary; including
opportunities for alternative shift-hours and weekends as
- Experience working in cleanroom environments under sterile or
aseptic conditions; must have experience in engineering standards
required for this type of operation.
- Must have good planning skills and must be willing to interface
with and guide colleagues in many different roles and functions
throughout the manufacturing facilities.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 standing, some bending, stooping, pushing,
pulling, reaching above shoulders and stretching.
- Use hand-eye coordination and manual dexterity sufficient to
operate a keyboard, photocopier, telephone, calculator, and other
- Lift up to 25 pounds frequently and up to 50 pounds, on
- Attendance is mandatory.Minimum Qualifications:
- Bachelor---s degree in Science, Engineering or other related
field and 1 year of technical experience; OR
- Associate---s degree in Science, Engineering or other related
field and 2 years of technical experience; OR
- High School/GED with 4 years of technical experience.Preferred
- Experience in developing training materials.
- Experience conducting and evaluating training.
- Experience with laboratory and or manufacturing
- Previous leadership roles.
- GMP experienceWe 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
Keywords: FDBT - FUJIFILM Diosynth, College Station , Manufacturing Associate Process Engineer, Engineering , College Station, Texas
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