Manufacturing Technician II

7 days ago

VIRGINIA STATE UNIVERSITY VA USA, United States BioSpace, Inc. Full time
Job Summary

Advanced level Manufacturing Technician position with the responsibility to weigh and dispense active pharmaceutical ingredients (API) and excipients in preparation of compounding. Compound bulk solutions for the filling operations and operate packaging equipment.

Key Responsibilities
  • Prepare cleaning and sanitizing solutions and perform daily, weekly, monthly cleaning of controlled and classified manufacturing areas.
  • Replenish manufacturing components, materials, and supplies in all processing areas.
  • Transport bright stock and finished product to and from staging as required according to manufacturing schedule.
  • Perform equipment cleaning and preparation for sterilization.
  • Operate sterilizer equipment to provide format parts for filling equipment. Clean, set up, and decontaminate material transfer isolator.
  • Clean, set up, and operate component processing equipment and terminal sterilizer equipment.
  • Clean, set up, and operate weighing and compounding equipment.
  • Weigh APIs and excipients according to batch record instructions.
  • Compound bulk drug product per standard operating procedures and batch record instructions.
  • Adhere to Civica procedures and policies, conform to current good manufacturing practices and good documentation practices.
  • Adhere to all safety regulations. Attend and participate in daily shift meetings to communicate events and issues to the manufacturing team.
Requirements
  • High school diploma or equivalent Coursework or bachelor's degree in a Life Science discipline preferred.
  • 2-3 years' Experience in a pharmaceutical or cGMP regulated environment.
  • High school graduate, vocational school graduate or equivalent
  • Working knowledge of Microsoft applications and SAP
  • Prior production experience
  • Experience working in a LEAN manufacturing environment.
  • Knowledge of cGMPs and FDA policies/procedures.

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