We're currently recruiting for an exciting opportunity with a Biopharmaceutical organization based in Dublin.
This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.
Key Responsibilities: Be accountable for success of the product transfer project from initiation to the transfer, through line characterisation, engineering studies, process performance qualification and ultimately to regulatory approval.
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.
Provide process development expertise for commercial drug product processing in specific areas such as sterile processing, process characterization, tech transfer and validation.
Support commercial drug product manufacturing operations with technical evaluation of Change Control/NC/CAPA and technology transfer.
The position will report to Process Development Senior Engineer.
Moderate international travel might be required during the course of the project.
Development of validation plans, process performance qualifications for vial and syringe filling.
Ensuring all aspects of activity within any given process validation adheres to required policies and procedures, including safety and training.
Ensure that the site meets the quality requirements of its customers and applicable regulations (FDA, EU