Engineering Project Manager

Atrium; Dublin; On-site; EUR 60,000 - 90,000; Full time

Job summary

Atrium is seeking an Engineer to join a leading global biopharmaceutical organisation in Dublin. In a GMP-regulated manufacturing environment, you will support process improvements, new product introductions, technology transfers, and operational excellence initiatives.

You will collaborate with Manufacturing, Engineering, Quality, Validation, and Supply Chain teams to drive improvements, troubleshoot issues, and ensure compliant documentation and successful tech transfers.

Qualifications

• Bachelor's degree in Engineering, Biotechnology, Pharmaceutical Science, or related discipline.
• Experience in pharmaceutical/biotech manufacturing environments.
• Strong understanding of cGMP regulations and manufacturing operations.
• Experience supporting manufacturing, engineering, validation, process improvement, CQV, or NPI activities.
• Excellent problem-solving and communication skills.
• Ability to work effectively within cross-functional teams.
• Upstream or Downstream biologics manufacturing experience.
• Technology Transfer or New Product Introduction (NPI) experience.
• Drug Product (DP) manufacturing experience.
• CQV (Commissioning, Qualification & Validation) experience.
• Experience with DeltaV, MES, SAP, Syncade, Kneat or similar systems.
• Lean Six Sigma or Continuous Improvement experience.

Responsibilities

• Support manufacturing operations and cross-functional project teams to deliver process improvements and operational excellence initiatives.
• Participate in New Product Introduction (NPI) and Technology Transfer projects.
• Support commissioning, qualification, and validation activities for manufacturing equipment and systems.
• Prepare and review GMP documentation, including SOPs, batch records, protocols, and reports.
• Investigate manufacturing issues, deviations, CAPAs, and change controls.
• Work closely with Manufacturing, Engineering, Quality, Validation, Supply Chain, and Technical Services teams.
• Drive continuous improvement initiatives to improve efficiency, compliance, and productivity.
• Support process troubleshooting, root cause analysis, and implementation of corrective actions.

Skills

Cross-functional teamwork

Problem-solving

Communication skills

Continuous improvement

Quality mindset

Education

Bachelor's degree in Engineering, Biotechnology, Pharmaceutical Science or related discipline

Tools

DeltaV

MES

SAP

Syncade

Kneat

Job description

Atrium is seeking a motivated Engineer to join a leading global biopharmaceutical organisation in Dublin. This is an exciting opportunity to work within a GMP-regulated manufacturing environment, supporting process improvements, new product introductions, technology transfers, and operational excellence initiatives.

Key Responsibilities

• Support manufacturing operations and cross-functional project teams to deliver process improvements and operational excellence initiatives.
• Participate in New Product Introduction (NPI) and Technology Transfer projects.
• Support commissioning, qualification, and validation activities for manufacturing equipment and systems.
• Prepare and review GMP documentation, including SOPs, batch records, protocols, and reports.
• Investigate manufacturing issues, deviations, CAPAs, and change controls.
• Work closely with Manufacturing, Engineering, Quality, Validation, Supply Chain, and Technical Services teams.
• Drive continuous improvement initiatives to improve efficiency, compliance, and productivity.
• Support process troubleshooting, root cause analysis, and implementation of corrective actions.

Requirements

• Bachelor's degree in Engineering, Biotechnology, Pharmaceutical Science, or a related discipline.
• Experience working within a pharmaceutical, biotechnology, or biologics manufacturing environment.
• Strong understanding of cGMP regulations and manufacturing operations.
• Experience supporting manufacturing, engineering, validation, process improvement, CQV, or NPI activities.
• Excellent problem-solving and communication skills.
• Ability to work effectively within cross-functional teams.
• Upstream or Downstream biologics manufacturing experience.
• Technology Transfer or New Product Introduction (NPI) experience.
• Drug Product (DP) manufacturing
• Equipment Commissioning, Qualification, and Validation (CQV).
• Experience with DeltaV, MES, SAP, Syncade, Kneat, or similar manufacturing systems.
• Lean Six Sigma or Continuous Improvement experience.