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Manufacturing Projects Scientist Engineer

Posted 26 days 4 hours ago by Next Generation (Ireland)

Permanent

Full Time

Other

Dublin, Dublin, Ireland

Job Description

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.