Manufacturing Process Engineer I

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 (MT&S) department at FDBU is seeking a Process Engineer I as an entry-level position. This position will report directly to the Director, MT&S, but may also have a functional reporting relationship to a senior colleague on a project to project basis.

The ideal candidate works independently and with colleagues to provide 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 familiar with a variety of core manufacturing and operational technologies including equipment used in: Fermentation, Cell Culture/Single Use Technology, Filtration, Centrifugation and Chromatography, Mixing and Buffer Preparation, Parts washing and Sterilization, and Homogenization.

 

MAJOR ACTIVITIES AND RESPONSIBILITIES:

  • Perform Commissioning, IQ, OQ and PQ activities for process equipment and utilities. This will include protocol preparation, scheduling, protocol execution, data analysis and authoring final reports.
  • Perform requalification of autoclaves, fermentors, bioreactors, controlled temperature chambers, and other process equipment.
  • Support HVAC requalification to support ongoing multiyear upgrade project
  • Execute Engineering Test Protocols to gather process characterization data to ensure equipment and facility are able to meet process needs. This would include thermal mapping of equipment, mixing studies, and product holds.
  • Develop and execute Steam in Place and Media Hold Performance Qualification protocols
  • Support cleaning validation activities (sampling, protocol generation, etc). as needed
  • Support water batch testing of equipment prior to the manufacturing of new products ensure Right First Time execution.
  • Participate in developments/ improvements to validation programs as needed to remain current with cGMPs and industry standards.
  • Support manufacturing deviations/investigations to identify root causes and define corrective and/or preventative actions (CAPA).
  • Other MT&S duties include developing, executing and implementing operational excellence projects to increase manufacturing efficiencies for personnel and equipment, training/certifying manufacturing personnel
  • Interface with Process Development and Process Sciences to support transfer of new processes into the manufacturing plant
  • Author and revise a variety of GMP manufacturing documents (e.g., Batch Records, SOPs, Work Instructions, item specifications, etc).

 

BACKGROUND REQUIREMENTS:

  • A BS/BA in science, engineering or other related field is preferred.
  • 1-3 years pharmaceutical related experience with degree.
  • Validation experience in Biotech/pharmaceutical processes is preferred.
  • Good working knowledge of cGMP requirements.
  • Experience with laboratory and/or manufacturing instruments/equipment 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.

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