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Packaging Development Specialist

  1. Dublin
Dublin
  1. Contract
Competitive
  1. Life Sciences
29-06-2023
31450

This vacancy has now expired

Packaging Development Specialist- Life Science – Contract- Dublin

Are you looking for the chance to join a life changing pharmaceutical organisation in their mission to continuously drive innovation? We are recruiting for a Packaging Development Specialist to support the Packaging Development Specialist function. 

Located 15 minutes from Dublin Airport and just a short distance from the lively, vibrant, and cultural Irish capital, this leading biopharmaceutical organisation paves the way with state-of-the-art technology on their one-of-a-kind manufacturing facility. 


Packaging Development Specialist Responsibilities
  • Ownership of the commercial packaging relationship with our contract manufacturers.
  • Leading troubleshooting and root cause analysis activities for critical issues at CMOs
  • Using lean six-sigma expertise to identify, analyse and prioritise optimisation at the FP level
  • Ensuring that all processes are appropriately validated and approved for manufacturing and partner with regulatory and QA colleagues to ensure that processes are maintained in a validated state and adhered to throughout their lifecycle.
  • Supporting the generation and review of oversight group input to  sections of the BLA and other technical documents for regulatory agency submission for commercial CMO sites.
  • Review, approve corrective/Improvement actions from Lifecycle change management as required
  • Communicating operational status of CMOs regularly to management, as required, at the appropriate level of detail, both orally and using written documents, and in formal and informal presentations.

About you:
  • Minimum of Bachelors degree in engineering (or similar technical Bachelors degree)
  • Comprehensive understanding of cGMP requirements for commercial manufacturing.
  • Excellent communication and influencing skills enabling him/her to influence both internal and external partners.
  • Ability to present and defend technical aspects of manufacturing operations during regulatory agency inspections.
 
Are you a good fit for a Packaging Development Specialist? Get in touch with us today.

 



The candidate must have the rights to work in the location stated in the job advert.

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