Manufacturing Process Engineer

About the role

Our client, a leading biopharmaceutical company in Waterford, is looking for a Manufacturing Process Engineer to provide technical leadership and process engineering support across its GMP‑regulated manufacturing operations. The role will drive continuous improvement, process optimisation and operational excellence while supporting new product introductions, technology transfers and capital projects.

Key responsibilities

• Provide process engineering support across manufacturing and development in a GMP environment.
• Identify, develop and implement continuous‑improvement initiatives to boost efficiency, quality and productivity.
• Lead technical problem‑solving, root‑cause investigations and corrective‑action implementation.
• Support planning, execution and delivery of capital projects related to manufacturing.
• Design, coordinate and execute process development programmes, plant trials and optimisation activities.
• Act as Subject Matter Expert for manufacturing processes, product quality attributes and critical process parameters.
• Participate in technology transfer, scale‑up and clinical supply manufacturing activities.
• Investigate complaints, deviations, laboratory investigation reports and CAPAs, ensuring timely closure.
• Develop, review and maintain GMP‑compliant manufacturing documentation.
• Monitor performance metrics and identify improvement opportunities.

Required profile

• Degree in Chemical Engineering, Industrial Engineering or a related engineering discipline.
• Advanced qualification in Pharmaceutics, Pharmacy or a related scientific field (advantageous).
• Experience in pharmaceutical or biotechnology manufacturing within a GMP‑regulated environment.
• Strong understanding of manufacturing processes, process optimisation and continuous‑improvement methodologies.

Required skills

• GMP compliance
• Process engineering
• Continuous improvement
• Root‑cause analysis
• CAPA management
• Process development and optimisation
• Technology transfer and scale‑up
• Capital project support
• Manufacturing documentation