Manufacturing Technician II

1 month ago

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

We are seeking an experienced Manufacturing Technician II to join our team at BioSpace, Inc. This advanced-level position involves weighing and dispensing active pharmaceutical ingredients (APIs) and excipients in preparation for compounding. The successful candidate will be responsible for operating packaging equipment, compound bulk solutions, and adhering to strict quality control measures.

Key Responsibilities
  • Prepare cleaning and sanitizing solutions, and perform daily, weekly, and 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 the manufacturing schedule.
  • Operate sterilizer equipment to provide format parts for filling equipment, and clean, set up, and decontaminate material transfer isolators.
  • Clean, set up, and operate component processing equipment, terminal sterilizer equipment, weighing and compounding equipment.
  • Weigh APIs and excipients according to batch record instructions, and 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.
  • Attend and participate in daily shift meetings to communicate events and issues to the manufacturing team.
Requirements
  • High school diploma or equivalent, with coursework or a bachelor's degree in a Life Science discipline preferred.
  • 2-3 years' experience in a pharmaceutical or cGMP regulated environment.
  • Working knowledge of Microsoft applications and SAP.
  • Prior production experience, with a working knowledge of LEAN manufacturing principles.
  • Knowledge of cGMPs and FDA policies/procedures.
Preferred Skills
  • Mechanical troubleshooting (manufacturing equipment).
  • Aseptic cleaning.
  • Equipment change part cleaning and sterilization.
  • Component/commodity sterilization.
  • Aseptic gowning/technique.
  • Good documentation practices.
  • Good reading and writing skills, and ability to perform basic to advanced mathematical calculations.

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