LSC have a great contract opportunity for Packaging Development Engineer to join a biopharmaceutical company in Dublin focused on serving patients with severe and ultra-rare disorders through the innovation, development, and commercialization of life-transforming therapeutic products.
ABOUT THE PROJECT - KEY 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.
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- Minimum of bachelor's degree in engineering (or similar technical bachelor's degree)
- Experience of MS Project or other project management software
- Exposure/experience of some packaging systems within a GMP environment - Stability, Change Control, Packaging processes, Serialization, ERP Inventory Systems
Note: Are you currently eligible to work in Ireland? As this is a contract opportunity you will need to hold a Stamp 1G/Stamp 4 visa to apply!
Apply via this advert or contact Pawel Jurkiewicz at LSC on 021-4777329 if you have any more questions about this role!