FUJIFILM Diosynth Biotechnologies-posted 2 months ago
Full-time
Holly Springs, NC
Merchant Wholesalers, Durable Goods

The Manufacturing Associate 2 executes and documents manufacturing processing activities per cGMP environment. This manufacturing facility will be 24/7 operational and the role will require working a 12 hour shift on a 2-2-3 Day Shift.

  • Contributes to the preparation for operational readiness related to bulk drug substance manufacturing.
  • Possible assignments include supporting projects related to procedure review and/or creation, development or transfer of manufacturing business processes, testing and commissioning support.
  • Executes and documents manufacturing processing steps and/or manufacturing support activities, process monitoring and control.
  • Performs in-process testing (pH, conductivity, visual inspection).
  • Executes validation protocols according to cGMP Standard Operating Procedures (SOPs).
  • Maintains training to perform all required activities.
  • This role requires shift work (weekend and potential for nights).
  • Perform other duties as assigned.
  • High School Diploma or GED and 2 years of related experience.
  • Associate degree, preferably in Life sciences or similar.
  • 2 years + direct experience in cGMP manufacturing environment.
  • Internal or after training: Qualified on a support area (i.e. Formulation Buffer Prep, Media Prep or DSM Buffer prep).
  • BioWorks or BTEC Capstone cGMP coursework preferred.
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