Manufacturing Process Engineer TPM6061

Tandem Project Management Ltd.; Waterford; On-site; EUR 60,000 - 75,000; Full time

Job summary

Tandem Project Management Ltd. is presenting an opportunity for a Manufacturing Process Engineer in Waterford, Ireland.

The role focuses on providing technical leadership, supporting manufacturing operations, and driving CI, process optimisation and capital projects within a GMP-regulated environment. The candidate will collaborate with Manufacturing, Quality, Engineering and Supply Chain teams to improve processes, support new product introductions, tech transfer and scale-up activities while

Qualifications

• Degree in Chemical or Industrial Engineering.
• Advanced qualification in Pharmaceutics would be advantageous.
• Experience in GMP-regulated pharma manufacturing.
• Strong understanding of manufacturing processes, optimization and CI.
• Experience with new product introductions, process development and tech transfer.
• Knowledge of aseptic manufacturing and lyophilisation would be advantageous.
• Experience with DoE and statistical analysis.
• Experience supporting investigations, deviations, CAPAs and change control.
• Lab or pilot plant experience would be beneficial.
• Strong project management, organizational and communication skills.
• Proficient in MS Office and technical report writing.

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 CPPs.
• 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, 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.

Skills

Process optimisation

Continuous improvement

GMP knowledge

DoE methodology

Project management

Quality systems

Education

Chemical Engineering

Industrial Engineering

Pharmaceutics (advantageous)

Tools

DoE

Minitab/JMP

Job description

Summary:

Our client, a leading biopharmaceutical company based in Waterford, is seeking a Manufacturing Process Engineer 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.

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.