Manufacturing Specialist - NPI (Biologics)
Location: Dublin, Ireland
Rate: €29.18 per hour
Contract: 12 months
We are seeking an experienced NPI Manufacturing Specialist to support new product introductions within a GMP biologics manufacturing environment.
Key Responsibilities
- Support NPI, technology transfer, engineering and PPQ batch activities.
- Complete NPI risk assessments and process impact assessments.
- Author/review Paper Batch Records (PBRs), SOPs and GMP documentation.
- Support product changeovers and manufacturing readiness for new products.
- Own/support change controls, CAPAs, investigations and process improvements.
- Partner with Manufacturing, QA, Engineering, QC, Supply Chain and Regulatory.
- Support introduction of new materials, consumables and Single-Use Technologies.
- Provide technical support and training to Manufacturing/Operations teams.
Requirements
- Degree in Science, Engineering or related discipline.
- 3-4 years' upstream (US) or downstream (DS) biologics manufacturing experience.
- 3-4 years' NPI experience within GMP manufacturing.
- Strong experience writing PBRs and SOPs.
- Knowledge of DeltaV, MES/Syncade and SAP.
- Experience with investigations, CAPAs and change controls.
- MES Electronic Batch Record (EBR) writing experience is advantageous.
