Manufacturing Projects Scientist Engineer

Next Generation; Dublin; On-site; EUR 33,000 - 47,000; Full time

Job summary

Next Generation is seeking an experienced NPI Manufacturing Specialist to support new product introductions within a GMP biologics environment in Dublin. You will drive NPI activities, technology transfer, engineering and PPQ batches, ensuring readiness for new products.

You should bring 3-4 years of biologics manufacturing and NPI experience, with strong skills in PBRs/SOPs, change controls, investigations and DeltaV, MES/Syncade and SAP.

Qualifications

• 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.

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

Biologics manufacturing

NPI experience

PBRs & SOPs writing

Change controls & CAPAs

Investigations

DeltaV / MES / Syncade / SAP

MES EBR writing

Education

Degree in Science, Engineering or related discipline

Tools

DeltaV

MES/Syncade

SAP

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.