Biologics NPI & Process Transfer Specialist
Next Generation
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Job summary
Next Generation is seeking a Manufacturing Process Specialist – Biologics to join our Dublin team. You will bring 3+ years of upstream or downstream biologics experience and contribute to NPI, tech transfer, PPQ and GMP batch documentation.
You will support NPI activities, risk assessments, write and review PBRs and SOPs, manage change controls and CAPAs, and partner with QA, Engineering and Regulatory to ensure manufacturing readiness for new products.
Qualifications
- 3+ years of upstream or downstream biologics manufacturing experience.
- 3–4 years NPI experience within GMP manufacturing.
- Experience writing PBRs and SOPs.
- Knowledge of DeltaV, MES/Syncade and SAP.
- MES Electronic Batch Record (EBR) writing experience is advantageous.
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.
Skills
Education
Tools
Job description
Next Generation is seeking a Manufacturing Process Specialist – Biologics to join our Dublin team. You will bring 3+ years of upstream or downstream biologics experience and contribute to NPI, tech transfer, PPQ and GMP batch documentation.
You will support NPI activities, risk assessments, write and review PBRs and SOPs, manage change controls and CAPAs, and partner with QA, Engineering and Regulatory to ensure manufacturing readiness for new products.
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