Production Technician III, Downstream Operations Specialist

3 weeks ago

Durham North Carolina, United States Fujifilm Full time
About the Role

Fujifilm Diosynth Biotechnologies, U.S.A., Inc. is seeking a highly skilled Production Technician III to join our team. As a key member of our production team, you will be responsible for executing development and production processes, as well as accompanying documentation.

Main Responsibilities
  • Execute development and production processes, including process documentation
  • Understand processing principles and scientific theory behind operations steps
  • Demonstrate proficiency at an advanced skill level
  • Troubleshoot equipment and processes
  • Authorize and route SOPs for approval
  • Assist in the execution of validation protocols
  • Initiate deviations as needed
  • Independently execute cGMP biotechnology production processes, training and directing lesser skilled employees to execute production process steps
  • Assist with lean continuous improvement projects
  • Lead others in the application of cGMPs for manufacturing documentation, facilities, and equipment in a biotechnology environment
  • Demonstrate a commitment to maintaining high standards of quality, cleanliness, and organization within the manufacturing environment
Requirements
  • High School diploma or equivalent
  • 2+ years cGMP biotechnology production experience
  • Mathematical aptitude, including the ability to complete conversions
  • Proficiency in Microsoft Office, including Outlook, Word, and Excel
  • General understanding of one or more of the following Upstream/Downstream processes: Ultrafiltration, Chromatography, Centrifugation or operation of centrifuges, Homogenizers, or depth filtration experience, Fermenters, bioreactors, Analytical equipment, Experience with PAS X (material control systems)
  • Ability to work a 12-hour shift
  • Must be able to wear a respirator
  • Physical Requirements: Push/pull over 35 pounds, frequently, Stand, crawl, bend, stoop, lift/mop overhead, use ladders and stairs frequently, Ability to work a 12-hour shift, Wear safety shoes, safety glasses, respirator, and other PPE
Working with Technical Data

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.

Equal Opportunity Employer

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.

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