Biopharma GMP Process Engineer - Manufacturing Excellence

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

Job summary

Tandem Project Management Ltd. is seeking a Manufacturing Process Engineer for a Waterford-based biopharmaceutical client. You will provide technical leadership and process engineering support across manufacturing operations, driving continuous improvement within a GMP-regulated environment.

You will collaborate with Manufacturing, Quality, Engineering and Supply Chain teams to optimize processes, support technology transfer and capital projects, and ensure compliant, reliable product supply.

Qualifications

• Degree in Chemical Engineering or related field.
• GMP/regulatory environment experience.
• Experience with DoE and statistics.
• Experience with technology transfer and capital projects.
• Strong project management and communication skills.

Responsibilities

• Provide process engineering support across manufacturing and development 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 for manufacturing processes 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.

Skills

Process modelling

Continuous improvement

GMP knowledge

DOE

Statistical analysis

Project management

Education

Degree in Chemical Engineering

Advanced qualification in Pharmaceutics (advantageous)

Job description

Tandem Project Management Ltd. is seeking a Manufacturing Process Engineer for a Waterford-based biopharmaceutical client. You will provide technical leadership and process engineering support across manufacturing operations, driving continuous improvement within a GMP-regulated environment.

You will collaborate with Manufacturing, Quality, Engineering and Supply Chain teams to optimize processes, support technology transfer and capital projects, and ensure compliant, reliable product supply.