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Sterile Processing and Validation Lead

3 weeks ago

Dublin, Dublin City, Ireland beBee Careers Full time

You will be responsible for troubleshooting issues related to drug substance freezing/thawing, formulation, filling, lyophilisation, inspection, and transportation.

Responsibilities:
  1. Supporting manufacturing operations with technical evaluations of Change Control/NC/CAPA and tech transfer.
  2. Providing process development expertise in sterile processing, process characterization, tech transfer, and validation.
  3. Meeting quality standards and regulations (FDA, EU, and international) related to CMC business processes.

A deep understanding of quality systems, drug product manufacturing, and validation is essential for success in this role.