LSC have a great contract opportunity for a Manufacturing Projects Scientist/Engineer to join a Dublin based Biopharmaceutical company dedicated to discovering, developing, and delivering innovative medicines that can help patients overcome serious diseases and improve their quality of life.
If you have 3-4 years of experience in upstream or downstream biologics manufacturing, strong New Product Introduction (NPI) experience and experience supporting manufacturing projects and GMP documentation, this could be the perfect opportunity for you!
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
- Support New Product Introduction (NPI) activities, including risk assessments, product changeovers and process impact assessments.
- Support process technology transfer and preparation of manufacturing documentation for development, engineering and PPQ batches.
- Work cross-functionally with Manufacturing, Engineering, QA, QC, Regulatory and Supply Chain to support new product start-ups and process changes.
- Provide SME input into the investigation and optimisation of manufacturing processes, procedures and documentation.
- Own and drive change controls, CAPAs, technical investigations and process improvement projects.
- Develop and approve GMP documentation, including SOPs, Paper Batch Records (PBRs) and electronic batch records, while supporting technical training and knowledge transfer to Operations.
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- 3-4 years' experience in an upstream (USP) or downstream (DSP) biologics manufacturing environment.
- 3-4 years' experience working on New Product Introductions (NPIs), including strong GMP manufacturing and technical investigation experience.
- Proficient in writing PBRs and SOPs, with knowledge of DeltaV, MES/Syncade and SAP; MES EBR writing experience is advantageous.
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 Andrea McSweeney on 021 4777329 if you have any more questions about this role!
