Summary: The Manufacturing Process Engineer I – TBF 100 is an entry-level position in the Manufacturing Technology Support (MT&S) department in support of the SATURN Project located at the Texas BioManufacturing Facility – 100 (TBF – 100) in College Station, Texas. This position will report directly to the Associate Director, MT&S, but may also jhave a functional reporting relationship to a senior colleague on a project to project basis.
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 proteins and 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 their use in cell propagation, Cell Culture/Single Use Technology, Dispensing and Mixing and Buffer Preparation. This position will also create training programs and perform training for manufacturing technicians in the unit operation categories.
Develop and maintain equipment and unit operation standards and procedures utilizing 4M (Man, Materials, Machinery and Methods) approach including:
(Materials) Understand process control and material inputs to ensure capable and acceptable process output.
(Machinery) Understand technology operation capabilities, limits and control strategies.
(Methods) Develop and maintain Technical Operational Manuals/Standard Operating Procedures/Work Instructions/Batch Records.
Required Skills & Abilities:
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:
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.