Commercial Process Engineer

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.

Our manufacturing organization is searching for a Commercial Process Engineer. The CPE will lead biopharmaceutical programs aimed at improving and saving patient’s lives. This role provides day-to-day leadership and oversight for the execution, standardization and monitoring of commercial product(s), as well as continuous improvement around production, compliance and safety for supported programs. This person would become the subject matter expert on core manufacturing and operational technologies for the manufacturing unit, including select commercial processes: Fermentation, Cell Culture/Single Use Technology, Filtration, Centrifugation and Chromatography.

Major Activities and Responsibilities

Essential Job Functions

Support the Readiness, Execution and Post Execution activity for commercial process (es) as part of the manufacturing operations. Ownership for process execution and batch release success, and a key member of the internal project team with client interactions.

Readiness

  • Preparation of Master Batch Records and Formulation Records and revisions.
  • Responsibility for preparation and revision of ETPs, supplemental instructions, standard work, coordination of supplemental sample plans and other readiness documents.
  • Facilitation on Potential Problem Analysis (PPA) sessions and implementation/coordination of countermeasures.
  • Conduct and Coordinate manufacturing process training.

Execution

  • Oversee the manufacturing process performance of commercial batches.
  • Assist production shifts to ensure smooth execution with minimal deviations. On time start > 90%, on time end > 90% and success criteria > 95%
  • Suite GEMBA and Support of critical operation oversight and batch record review on the floor.

Post Execution

  • 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 or facilitate Problem Analysis (PA) events, as needed.
  • Owner of corrective and preventive measures and change controls related to the program (s).
  • Support Regulatory filings and updates as needed.
  • Performing process evaluation and trend analysis using statistical tools supporting routine monitoring and author the annual product review report.
  • Maintain and evaluate metrics on process performance. Develop and publish to dashboard on key performance indicators.

Other Program Support

  • Champion process improvements and manage funding (possible capital project) and implementation of improvements for sustained results.
  • Support new equipment and process validation activities.
  • Provide support during audits and with audit observation closure.
  • Prepare and revise SOPs and WI related directly to the commercial manufacturing processes.
  • Provide process or unit operation training to new team members and periodicals, as needed.
  • Attend and Participate in meetings, including tier meeting, internal and external client calls, team huddles, business review meetings, and others as needed.

Background Requirements

  • BS/BA in science, engineering or other related field
  • Minimum 10 years’ experience, with at least 5 years’ experience in the biotech industry
  • Biopharmaceutical Plant experience
  • Good working knowledge of cGMP requirements
  • Experience in developing, conducting and evaluating training
  • Experience with laboratory and/or manufacturing instruments/equipment
  • Experience with Biotech/pharmaceutical processes required
  • Previous leadership experience
  • Due to the various interactions with external and internal groups, interpersonal, leadership and organizational skills are essential attributes
  • Ability to work in a cross functional team environment.

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.

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