Technical Writer

3 weeks ago


Libertyville, United States Cynet Systems Inc. Full time

The MSAT Tech Writer:

  • Compiles and interprets manufacturing process data to identify possible failure modes.
  • Learns complex cell biology concepts & applies them to root cause investigations.
  • Works independently and with Process Engineer(s) to understand different failure modes.
  • Works with GMP Quality Systems to deliver completed Root Cause Analysis investigation reports.

Education:

  • BS in Bio/Chem Science/Engineering or related field.
  • Immunology education is preferred.

Experience :

  • 3+ years relevant experience in drug product biopharmaceutical or equivalent industry.
  • Deviation writing.
  • cGMP/cGDP.
  • Ability to prioritize multiple investigations in order to meet deadlines.
  • Strong scientific and technical acumen including technical writing skills.
  • Quality management system.
  • Complex problem-solving skills, including root cause investigation.
  • Cross-functional collaboration with engineering and quality partners.
  • Biologics or cell therapy manufacturing.
  • Trained in Kepner Tregoe Problem Solving.

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