Transfer Process Engineer

2 weeks ago


Dublin, Dublin City, Ireland beBeeProcess Full time €80,000 - €120,000
Process Development Specialist

The role of the Technical Transfer specialist is to provide process development support primarily to new product introductions (NPI) and lifecycle management (LCM) changes.

  • Key Responsibilities:

The specialist will provide solutions when trouble shooting drug substance freezing/thawing, formulation, filling vials/syringes/devices, lyophilisation, inspection and transportation for parenteral products through the NPI or post-NPI phases. Additionally, they will provide process development expertise for commercial drug product processing in specific areas such as sterile processing, process characterization, tech transfer and validation.

  • Key Tasks:
  1. Provide technical evaluation of Change Control/NC/CAPA and technology transfer.
  2. Development of validation plans, process performance qualifications for vial and syringe filling.
  3. Ensure that the site meets the quality requirements of its customers and applicable regulations (FDA, EU & international standards).

The specialist will also support commercial drug product manufacturing operations with a full understanding of CMC business process related to technology transfer.



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