Manufacturing - Associate Process Engineer
Company: FDBT - FUJIFILM Diosynth
Location: College Station
Posted on: January 12, 2021
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Job Description:
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 revision.* Creation and or revision of recipe or
methods for various platforms.* Review and/or Approve equipment
qualification limits.* Review Calibration Tolerances and Approve
Out of Tolerance Investigations* 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 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 office equipment.*
Lift up to 25 pounds frequently and up to 50 pounds, on occasion.*
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 Qualifications:* Experience in developing
training materials.* Experience conducting and evaluating
training.* Experience with laboratory and or manufacturing
instruments/equipment.* 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 call
979-431-3528.
Keywords: FDBT - FUJIFILM Diosynth, College Station , Manufacturing - Associate Process Engineer, Other , College Station, Texas
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