Manufacturing Process Engineer I
Company: FUJIFILM Diosynth Biotechnologies
Location: College Station
Posted on: January 5, 2022
: The Manufacturing Process Engineer I position 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 BioManufacturing
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: (Man) Develop
and deliver effective skill building and training plans for a given
operational technology to manufacturing technicians.
- Collaborate with individuals and teams of technicians &
managers on self-development plans.
- Implement e-learning, video, classroom and in suite design and
delivery as appropriate.
- Create and maintain the technical training manuals and
personnel certification process.
- Develop and assure alignment of training and skill building
activities to site business requirements.
- Assure local operational practice reflect local procedure and
- Provide guidance and direction on cross-functional training
initiatives. (Materials) Understand process control and material
inputs to ensure capable and acceptable process output.
- Ensure supplies are in place to execute water runs and
Engineering Test Plans/Studies (Machinery) Understand technology
operation capabilities, limits and control strategies.
- Review and/or Approve equipment qualification limits.
- Review Calibration Tolerances and Approve Out of Tolerance
- Represent the manufacturing unit for equipment purchase, new
technology and changes to equipment.
- Coordinate validation, calibration and PM completion of
manufacturing lab equipment
- Creation and or revision of recipes or methods for various
- Represent the manufacturing unit for equipment purchase, new
technology and changes to equipment. (Methods) Develop and maintain
Technical Operational Manuals/Standard Operating Procedures/Work
- Lead operational technology standardization, standard batch
templates and instruction interfaces and lead continuous
improvement for a given technology.
- Assist in the transfer and scale up of new processes and
technologies to the manufacturing plant ensuring requirements for
EHS and cGMP compliance.
- Ensure procedures are in place to execute water runs and
Engineering Test Plans/Studies
- Interface with Process Development and Process Science to
ensure smooth transfer of processes into the manufacturing
- Develop and approve procedures and batch records.
- Review batch records, process validation protocols, process
specifications, BOMs, campaign summary reports and other
documentation as needed. 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 required.
- 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:
- Master's degree in Science, Engineering or other related field
and 1 years of relevant experience
- Bachelor's degree in Science, Engineering or other related
field and 3 years of relevant experience;OR
- Associate's degree in Science, Engineering or other related
field and 4 years of relevant experience; OR
- High School/GED with 7 years of relevant experience.
- Above experience must include one (1) year GMP Preferred
- Experience in developing training materials.
- Experience conducting and evaluating training.
- Experience with laboratory and or manufacturing
- Previous leadership roles.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 email or call .#LI-SB2
Keywords: FUJIFILM Diosynth Biotechnologies, College Station , Manufacturing Process Engineer I, Engineering , College Station, Texas
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