Process Engineer (Manufacturing)

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

Job summary

Tandem Project Management Ltd. in Waterford is seeking a Process Engineer (Manufacturing) for a client in the biopharmaceutical sector.

The role provides technical leadership and engineering support across GMP manufacturing operations, driving continuous improvement, process optimisation and operational excellence. You will collaborate with Manufacturing, Quality, Engineering and Supply Chain to improve processes, support technology transfer, NPI, and capital projects while ensuring compliance

Qualifications

• Degree in Chemical Engineering or related discipline.
• Advanced qualification in Pharmaceutics or related discipline is advantageous.
• Experience in pharmaceutical/biotech GMP manufacturing environment.
• Experience with DoE and statistical analysis methods.
• Strong project management and communication skills.

Responsibilities

• Provide process engineering support across manufacturing and development operations within GMP.
• Collaborate with internal/external stakeholders to improve processes and performance.
• Lead continuous improvement initiatives to enhance efficiency, quality and productivity.
• Support capital projects related to manufacturing operations and technology transfer.
• Lead problem-solving, root cause investigations and corrective actions.
• Drive cycle time reduction and implement best manufacturing practices.
• Coordinate process development programmes, plant trials and optimisations.
• Act as SME for manufacturing processes, quality attributes and CPPs.
• Support new product introductions and product enhancements.
• Participate in technology transfer and scale-up activities.
• Support clinical supply manufacturing as required.
• Design/execute experimental programmes to support development.
• Review/managing GMP-compliant manufacturing documentation.
• Monitor performance metrics and identify improvement opportunities.

Skills

Process Engineering

GMP Experience

DoE

CAPA & deviations

Statistical Analysis

Documentation

Communication

Education

Bachelor in Chemical/Industrial Engineering

Advanced qualification in Pharmaceutics or related

Tools

MS Office

DoE software

Job description

During the training period (from 1 to 3 months), the expectation is to be on-site.

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.

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.