FUJIFILM Diosynth Biotechnologies U.S.A., Inc. is seeking a Process Scientist/Engineer II to join our Process Sciences group. The successful candidate will represent the group before FDBU customers, regulatory agencies and management. This individual will participate in new client processes and ensure project objectives are completed. They will also contribute to the technology transfer of one or multiple projects at various project life-cycle states (clinical material to commercial supply). Additionally, this individual must possess strong process understanding to implement and execute process risk review and process/cleaning qualification and validation activities.
Major activities and responsibilities:
- Support process validation and technical transfer of client projects as applicable
- Summarize and report data
- Interact with Supervisor and report results and interpretation of data, project deliverables, and process readiness
- Assist in developing GMP documentation including but not limited to Process Validation Protocols, Engineering Test Plans and engineering documents
- Consult with Senior peers on non-complex process engineering projects to learn through experience
Education and Experience required:
- BS and 4+ years related experience
- Biology, Chemistry or biochemistry knowledge
- Understanding of analytical or process experimental design
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.