Team Horizon is seeking a Project Engineer (Senior) for our client based in Dublin.
This role will require the candidate to support manufacturing at various aseptic drug product contract manufacturing sites around Europe.
Assignments may include support for new product introductions, lifecycle changes and ongoing commercial production
Why you should apply
This is an excellent opportunity to join a world class manufacturing operation, with an outstanding track record of reliably delivering high-quality medicines to patients around the world suffering serious illnesses.
There is a strong culture of continuous improvement and innovation within the company to strive for solutions that improve health outcomes and dramatically improve people's lives.
Our client is developing the capability to produce all its medicines in Dublin, helping to ensure continuity of supply of our medicines as they expand internationally.
What you will be doing
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
What you need to apply
3 -5 years' 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
Experience dealing with contract manufacturing organisations
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