We are ‘Advancing tomorrow’s medicines’ and making a real difference to the world in which we live. At Fujifilm Diosynth Biotechnologies, we partner with our clients to deliver recombinant proteins, viral vaccines and gene therapies to patients. As a Contract Development & Manufacturing Organization (CDMO), our focus is to combine technical leadership in cell culture, microbial fermentation and viral vectors with world class GMP manufacturing facilities to advance tomorrow’s medicines. We seek candidates with proven ability to work independently and collaboratively to achieve optimized strategies, and execution programs with the ultimate goal of delivering products that transform the lives of patients.
The Manufacturing Technology & Support group is seeking a highly motivated individual for a Staff Engineer – Downstream position. This is a high-level position within the group. This position will directly report to the Manager of Validation, but may also have a functional reporting relationship to a senior colleague on a project-to-project basis.
MAJOR ACTIVITIES AND RESPONSIBILITIES:
- Work under minimal supervision on complex projects and may assist/direct less experience peers (20%)
- Wide latitude for independent judgment (5%)
- Support capital projects by providing technical expertise (10%)
- Manage large complex engineering projects (10%)
- Demonstrate supervisory skills with outside contractors and consultants (5%)
- Apply engineering design principles (10%)
- Demonstrate production troubleshooting knowledge (10%)
- Support development of engineering and technology transfer policies (5%).
- Prepare and deliver presentations to external audiences (10%)
- Identify process improvements and implement (10%)
- Other duties as assigned (5%)The ideal candidate will be expected to attend all internal hands-on training for the SOP’s in the curriculum assigned to the position.
- The Technical Operations department provides 24 hour support to manufacturing. Execution of activities may be required outside of core business hours.
The Major Equipment and Systems that are supported include:
- DCS manufactured by Asea Brown Boveri (ABB).
- Fermentation and Cell Culture reactors manufactured by Applikon and Braun.
- Recovery centrifuges manufactured by Westfalia and Carr.
- LPC Skids manufactured by GE Healthcare.
- UFDF/NFF Skids manufactured by Millipore and Pall.
- Single Use Equipment manufactured by various vendors, including Xcellerex (GE) and Sartorius.
- Ability to work in a cross functional team environment
- BSc. degree or equivalent.
- A minimum of 10 years of GMP experience is required
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.