Process Engineer (Manufacturing)

Tandem Project Management Ltd.; Munster; On-site; EUR 65,000 - 90,000; Full time

Job summary

Tandem Project Management Ltd. client in Waterford seeks a Process Engineer (Manufacturing) to provide technical leadership and process engineering support across GMP manufacturing operations.

The role drives continuous improvement, process optimisation and operational excellence, supporting new product introductions, technology transfer activities and capital projects while ensuring compliance with quality, safety and regulatory requirements.

Qualifications

• Degree in Chemical Engineering, Industrial Engineering or related field.
• Advanced qualification in Pharmaceutics or related science is advantageous.
• Experience in GMP-regulated pharmaceutical manufacturing environment.
• Familiar with DoE and statistical analysis techniques.
• Experience with technology transfer, process development and CAPA handling.

Responsibilities

• Provide process engineering support across manufacturing and development within GMP.
• Collaborate with stakeholders to improve processes and performance.
• Lead continuous improvement initiatives for efficiency and quality.
• Support capital projects in manufacturing operations.
• Lead root-cause investigations and implement corrective actions.
• Drive cycle time reduction and adoption of best manufacturing practices.
• Support technology transfer and scale-up activities.
• Develop manufacturing documentation compliant with cGMP.
• Monitor performance metrics and identify improvement opportunities.

Skills

GMP manufacturing

Continuous improvement

Process development

Project management

Root cause analysis

Quality documentation

Education

Bachelor's degree in Chemical Engineering or related

Advanced qualification in Pharmaceutics or related

Tools

Microsoft Office

DoE

Statistical analysis

Job description

Our client, a leading biopharmaceutical company based in Waterford, is seeking a Process Engineer (Manufacturing) to join their team. The successful candidate will provide technical leadership and process engineering support across manufacturing operations, driving continuous improvement, process optimisation and operational excellence within a GMP-regulated environment. This role will support manufacturing performance, new product introductions, technology transfer activities and capital projects while ensuring compliance with quality, safety and regulatory requirements. The position offers the opportunity to work closely with Manufacturing, Quality, Engineering and Supply Chain teams to improve manufacturing processes and support reliable product supply.
During the training period (from 1 to 3 months), the expectation is to be on-site.

Responsibilities

• Provide process engineering support across manufacturing and development operations within a GMP environment.
• Work closely with internal and external stakeholders to improve manufacturing processes and operational performance.
• Identify, develop and implement continuous improvement initiatives to enhance manufacturing efficiency, quality and productivity.
• Support the planning, execution and delivery of capital projects relating to manufacturing operations.
• Lead technical problem-solving activities, root cause investigations and implementation of effective corrective actions.
• Drive cycle time reduction initiatives and support the implementation of best manufacturing practices.
• Design, coordinate and implement process development programmes, plant trials and process optimisation activities.
• Act as a Subject Matter Expert (SME) for manufacturing processes, product quality attributes and critical process parameters.
• Support new product introductions, formulation improvements and product enhancement programmes.
• Participate in technology transfer and scale-up activities to support manufacturing operations.
• Support clinical supply manufacturing activities where required.
• Design and execute experimental programmes to support process development and manufacturing improvements.
• Support process laboratory activities and evaluate process performance data.
• Investigate complaints, deviations, laboratory investigation reports (LIRs) and CAPAs, ensuring timely root cause analysis and effective closure.
• Develop, review and maintain manufacturing documentation, ensuring compliance with GMP requirements.
• Monitor manufacturing performance metrics and identify opportunities for improvement.
• Ensure all activities are carried out in compliance with cGMP, quality and regulatory requirements.

Qualifications & Experience

• Degree in Chemical Engineering, Industrial Engineering or a related Engineering discipline.
• Advanced qualification in Pharmaceutics, Pharmacy or a related scientific discipline would be advantageous.
• Experience within pharmaceutical or biotechnology manufacturing in a GMP-regulated environment.
• Strong understanding of manufacturing processes, process optimisation and continuous improvement methodologies.
• Experience supporting new product introductions, process development and technology transfer activities.
• Knowledge of aseptic manufacturing and lyophilisation processes would be advantageous.
• Experience with Design of Experiments (DoE) and statistical analysis techniques.
• Experience supporting manufacturing investigations, deviations, CAPAs and change control processes.
• Laboratory or pilot plant experience would be beneficial.
• Strong project management, organisational and communication skills.
• Proficient in Microsoft Office applications and technical report writing.