FUJIFILM Diosynth Biotechnologies U.S.A., Inc. is seeking a Senior Cleaning Validation Engineer (internally known as Manufacturing Senior Process Engineer - Cleaning Validation). This is an upper level position in the Manufacturing Technology Support (MT&S) department at FDBU. This position will report directly to the Director, MT&S.
The successful candidate 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: Fermentation, Cell Culture/Single Use Technology, Filtration, Centrifugation and Chromatography. Core manufacturing technologies include Weigh and Dispensing, Mixing and Buffer Preparation, Parts washing and Sterilization, and Homogenization.
MAJOR ACTIVITIES AND RESPONSIBILITIES:
FDBU works with technical data, technology and materials that are subject to U.S. export laws and regulations. This position will require access to technical data, technology and source code that is controlled under U.S. export laws and regulations, including but not limited to the International Traffic in Arms Regulations at 22 C.F.R. Parts 120 – 130 and Export Administration Regulations in 15 C.F.R. Part 730 – 774, as may be amended. To conform to these laws and regulations, applicants must be U.S. citizens, lawful permanent residents of the U.S., protected individuals as defined by 8 USC 1324(b)(a)(3) (i.e., asylees and refugees) or otherwise eligible for an export authorization from the U.S. Department of State or U.S. Department of Commerce. Offers of employment will be contingent on the Company’s ability to secure an export authorization. FDBU is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation, gender identify or any other protected class.
FDBU is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation, gender identify or any other protected class.