Aseptic Process Engineer for Pharma NPI & Tech Transfer

EFOR; Galway; On-site; EUR 65,000 - 95,000; Full time

Job summary

EFOR Group in Galway is seeking an expert Process Engineer/Technical Services Engineer to optimise aseptic manufacturing processes for sterile products and drive new product introductions. You will lead technology transfer, support cross-functional teams, and ensure regulatory compliance and operational excellence.

With 3+ years in pharmaceutical manufacturing and hands-on experience in aseptic technologies, you will conduct FMEA, investigations and continuous improvement.

Qualifications

• Bachelor’s or Master’s in Chemical/Pharma/Biotech Engineering or related field.
• 3+ years’ experience in pharmaceutical manufacturing, process engineering, or technical services.
• Experience in sterile injectables or biologics manufacturing preferred.
• Strong knowledge of cGMP, Annex 1, FDA, EMA, ICH, and validation protocols.
• Hands-on aseptic tech, lyophilization, and process equipment experience.

Responsibilities

• Develop, optimise and validate sterile manufacturing processes.
• Lead technology transfer, alternate source qualification and NPI.
• Support production with troubleshooting across manufacturing phases.
• Perform risk assessments (FMEA), lead deviation investigations and CAPA.
• Collaborate with Production, Quality, Regulatory and Engineering for scale-up and commercialization.

Skills

Aseptic manufacturing

Process engineering

Regulatory compliance

FMEA

Cross-functional teamwork

Troubleshooting

Education

Bachelor’s or Master’s in Chemical/Pharma/Biotech Engineering or related field

Tools

SCADA

MES

PAT

Job description

EFOR Group in Galway is seeking an expert Process Engineer/Technical Services Engineer to optimise aseptic manufacturing processes for sterile products and drive new product introductions. You will lead technology transfer, support cross-functional teams, and ensure regulatory compliance and operational excellence.

With 3+ years in pharmaceutical manufacturing and hands-on experience in aseptic technologies, you will conduct FMEA, investigations and continuous improvement.