Global Biotechnology company, based in south Dublin, Ireland - looking for
Snr Project Engineer
.
This role will be part of the global Process Development organization.
The candidate will be responsible to support manufacturing at various aseptic drug product contract manufacturing sites around Europe. Assignments may include support for new product introductions, life-cycle changes and ongoing commercial production.
The role:
* Develop as a drug product technical expert, to provide leadership and solutions troubleshooting parenteral drug product manufacturing, for all processing stages from drug substance thawing, formulation, filling, lyophilisation, inspection, and transportation of vials, syringes and devices for parenteral products through the new product introduction (NPI) or commercial phases.
* Work with contract manufacturing partner SME's, Global Operations, Contract Manufacturing Quality and drug product process teams.
* Work as a member of cross site teams to support contract manufacturers and to identify and resolve potential issues.
* Provide process development expertise for commercial drug product processing in specific areas such as aseptic processing, process characterisation, technology transfer, and process validation.
* Troubleshoot issues with drug product processing technologies and equipment.
* Identify and implement operational improvements for current and new sterile operations.
* Support commercial drug product manufacturing operations and contract manufacturing quality with technical evaluation of NC/CAPA.
* Visit contract manufacturing sites to observe production operations and build relationships.
Have You:
* 3 -5 year's pharmaceutical manufacturing experience in either a drug product or drug substance manufacturing environment.
* Masters or PhD in a Science or Engineering or related discipline
* Experience with aseptic drug product processes such as; component preparation (siliconization, autoclaving, depyrogenation), sterile filtration, filter integrity testing, filling, freeze drying, capping, manual and automated visual inspection
* Experience with different aseptic drug product presentations such as pre-filled syringes, cartridges, lyophilised vials and liquid vials
* Experience with the quality testing methods and interpretation of results for biological molecules
* Aseptic drug product validation experience such as; media fill, sterilisation validation, equipment qualification, process validation
* Excellent oral and written communications skills.
* Strong academic results in a third level bachelor's degree in Science, Engineering or a relevant quality discipline.
* Full clean driving licence required to facilitate travel.
The successful candidate must have eligible working VISA in Ireland or European Union (EU) passport.
Berkley Life Science & Engineering is a specialist consultancy, recruiting professionals for organizations throughout Ireland, UK & Europe; for more information go to www.berkley-
If you would like to discuss this vacancy further or to discuss your career options in confidence, please telephone Aleksas Kremenskas at or send your profile to -