Commercial Process Engineer II

Company: FDBT - FUJIFILM Diosynth
Location: Durham
Posted on: January 15, 2021

Job Description:

Overview The Bio Therapeutic Commercial Process Engineer II (Internally known as a Commercial Process Engineer II) is part of the Manufacturing Organization. The individual in this role works under general supervision with the latitude for independent judgment. This role provides day-to-day leadership and oversight for the monitoring of commercial product(s), as well as continuous improvement around production, compliance and safety for supported programs. This position requires an understanding of core manufacturing and operational technologies for the manufacturing unit, which include: Fermentation, Cell Culture/Single Use Technology, Filtration, Centrifugation and Chromatography. Additionally, this position will be responsible for supporting deviation investigations, internal and regulatory document updates, as well participating in client and regulatory audits.External US The Bio Therapeutic Commercial Process Engineer II (Internally known as a Commercial Process Engineer II) is part of the Manufacturing Organization. The individual in this role works under general supervision with the latitude for independent judgment. This role provides day-to-day leadership and oversight for the monitoring of commercial product(s), as well as continuous improvement around production, compliance and safety for supported programs. This position requires an understanding of core manufacturing and operational technologies for the manufacturing unit, which include: Fermentation, Cell Culture/Single Use Technology, Filtration, Centrifugation and Chromatography. Additionally, this position will be responsible for supporting deviation investigations, internal and regulatory document updates, as well participating in client and regulatory audits.The work we do at FUJIFILM Diosynth Biotechnologies has never been more important-and we are looking for talented candidates to join us. We're growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people's lives. Join FDB and help create the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe. Here, you'll work alongside and learn from some of the most dedicated scientists, engineers, and manufacturers in the industry. We're proud to cultivate a culture that will fuel your passion, energy, and drive-what FDB calls Genki. Join us and discover a community that thrives on diversity and never scares away from a complex challenge. At FDB, you determine what's possible.MAJOR ACTIVITIES AND RESPONSIBILITIES:Essential Job Functions:Support the Readiness, Execution and Post Execution activity for commercial process (es) as part of the Manufacturing Commercial Operations team. Provide ownership for process deviations, as well as client and regulatory document updates and inspections.Readiness* Revisions of Master Batch Records and Formulation Records* Responsibility for preparation, revision and execution of ETPs, supplemental instructions, standard work, coordination of supplemental sample plans and other readiness documents* Participation on Potential Problem Analysis (PPA) sessions and implementation/coordination of countermeasures* Conduct and Coordinate manufacturing process trainingExecution* Support the manufacturing process performance of commercial batches as the technical lead* Support/Lead program GEMBAs* Support oversight for critical operations on the floor* Provide updates/escalations to Upper Management or ClientsPost Execution* Support Coordinators to ensure records are timely, accurate and complete for QA review. Respond or coordinate response to questions, comments from QA and client* Manage Deviations (open, data gathering, investigation, comment resolution) in a timely manner* Support Problem Analysis (PA) events, as needed* Own corrective and preventive measures and change controls related to the program(s)* Maintain and evaluate metrics on process performance* Perform process surveillance and trend analysis using statistical tools for routine monitoring and the annual product review report.Other Program Support* Own deviation impact assessments and program deviations, as needed* Support new equipment and process validation activities, as needed* Prepare and revise SOPs and WI related directly to the commercial manufacturing processes* Provide process or unit operation training to new team members and periodically, as needed* Attend and participate in meetings, including tier meeting, internal and external client calls, team huddles, business review meetings, and others as neededSCOPE MEASURES:* Typically has direct impact on program deliverables and performance* Helps drive Commercial Operations team resultsBACKGROUND REQUIREMENTS:* BS/BA in science, engineering or other related field* Minimum 4+ years' experience or MS or equivalent* Demonstrates practical understanding of biological process manufacturing, process experimental design and problem solving* Demonstrates knowledge of complex instrumentation, computer systems and software for data acquisition and analysis* Good working knowledge of cGMP requirements* Strong interpersonal, leadership and organizational skills due to the various interactions with external and internal groups* Ability to work in a cross functional team environmentFDBU 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 identity or any other protected class.SDL2017

Keywords: FDBT - FUJIFILM Diosynth, Durham , Commercial Process Engineer II, Other , Durham, North Carolina