Manufacturing Process Specialist – Biologics

Next Generation; Dublin; On-site; EUR 81,278,000 - 85,824,000; Full time

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

Upstream/Downstream experience

NPI experience

Tech transfer

GMP documentation

Education

Degree in Science/Engineering

Tools

DeltaV

MES/Syncade

SAP

Job description

Manufacturing Process Specialist – Biologics

Location: Dublin, Ireland

Rate: €29.18 per hour

Contract: 12 months

We're looking for a biologics manufacturing professional with 3+ years' upstream or downstream experience and exposure to NPI, tech transfer, PPQ and GMP batch documentation.

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.