Demo

Aseptic Manufacturing Technician II

R&D Partners
Philadelphia, PA Full Time
POSTED ON 1/9/2025
AVAILABLE BEFORE 4/9/2025

Duties :

  • R esponsible for various tasks, such as cleaning, sanitization, preparation, and fulfilling products for commercial and clinical use.
  • Perform document review, including executed Batch Records and Logbooks.
  • Support documentation needs, which include a review of SOPs, Batch Records, Deviations, CAPAs, etc.
  • Supports technical transfer and additional research-level testing activities as needed
  • May support training sessions as a qualified trainer, ensuring training documentation is maintained.

Qualifications :

  • Minimum 2 years of experience in biopharmaceutical-based GMP manufacturing operations, including experience in cell culture and associated downstream processing.
  • Quality mindset, familiar with 21 CFR Part 11 and standard GxP best practices and FDA
  • Preferably with experience in cell culture, aseptic gowning and qualification, and ISO class 5 cleanroom operation
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