Process Engineer

EFOR; Galway; Presencial; EUR 65 000 - 95 000; Tempo integral

Resumo da oferta

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.

Qualificações

• 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.

Responsabilidades

• 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.

Conhecimentos

Aseptic manufacturing

Process engineering

Regulatory compliance

FMEA

Cross-functional teamwork

Troubleshooting

Formação académica

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

Ferramentas

SCADA

MES

PAT

Descrição da oferta de emprego

Are you an expert in aseptic pharmaceutical manufacturing, eager to optimise processes and drive new product introductions? EFOR Group, a trusted Life Sciences consulting partner, is seeking a skilled Process Engineer/Technical Services Engineer to join our team in Galway.

What you’ll do:

• Develop, optimise, and validate robust pharmaceutical manufacturing processes for sterile products, ensuring regulatory compliance and operational excellence
• Drive technology transfer, alternate source qualification, and successful new product introductions (NPI)
• Support production teams with troubleshooting and resolving complex process challenges across all manufacturing phases
• Perform risk assessments (FMEA), lead root cause investigations for deviations, and implement continuous improvement initiatives
• Collaborate cross-functionally with Production, Quality, Regulatory, and Engineering to ensure seamless process scale-up and commercialisation

Your background:

• Bachelor’s or Master’s in Chemical/Pharma/Biotech Engineering or related field
• Over 3 years’ experience in pharmaceutical manufacturing, process engineering, or technical services
• At least two years’ experience in sterile injectables or biologics manufacturing
• Detailed knowledge of cGMP, Annex 1, FDA, EMA, ICH, and validation/qualification protocols (PPQ, CPV)
• Hands‑on experience with aseptic technology, lyophilization, risk assessments, and process equipment (filling, isolators, autoclaves, etc.)
• Strong analytical mindset, excellent communication, and proven ability to work in cross-functional teams
• Lean/Six Sigma certification, experience with automation systems (SCADA, MES), or PAT is an advantage