Process Engineer

Job DescriptionSummary: A Process Engineer is required for a biopharmaceutical company in West Dublin. The successful candidate will support Drug Substance manufacturing processes, providing technical expertise across manufacturing operations and process improvement initiatives. The role will focus on process engineering activities including technology transfer, process validation, manufacturing support, data analysis and continuous improvement, while working closely with cross-functional teams to optimise manufacturing performance and ensure compliance with GMP standards.

Responsibilities: Provide technical support for Drug Substance manufacturing processes across all stages of the product lifecycle. Support the introduction and implementation of Event Frames for manufacturing process monitoring and data visualisation. Provide technical input throughout technology transfer, process scale-up, process validation and routine commercial manufacturing activities.

Collaborate with Operations, Technical Services, Quality Assurance, Automation and Data Analytics teams to support manufacturing operations and project delivery. Collect, organise, trend and analyse GMP manufacturing data, including statistical analysis to identify opportunities for process optimisation. Troubleshoot manufacturing issues and work with site teams to implement effective solutions.

Identify, scope and deliver continuous improvement projects to enhance manufacturing efficiency, process capability and operational performance. Support process monitoring activities and recommend improvements based on manufacturing data and process performance. Contribute to cross-functional projects while ensuring compliance with GMP requirements and site procedures.

Maintain accurate technical documentation and support engineering investigations as required. Qualifications & Experience: Degree qualification in Chemical Engineering, Mechanical Engineering, Pharmaceutical Engineering, Science or a related discipline. Experience within a pharmaceutical or biopharmaceutical manufacturing environment.

Experience supporting manufacturing processes, technology transfer, process validation or process scale-up activities. Knowledge of GMP manufacturing environments and quality systems. Experience with Functional Design Specifications (FDS) and process mapping.

Strong analytical skills with experience collecting and interpreting manufacturing data. Proficient in Microsoft Excel, Word and PowerPoint, with strong Excel skills preferred. Excellent communication and stakeholder management skills.

Experience with quality systems such as TrackWise, EQV, deviation management or similar systems would be advantageous. Exposure to project management methodologies and continuous improvement tools such as Lean or Six Sigma would be beneficial. Demonstrated ability to identify process improvements, take initiative and drive positive change within a manufac TPBN1_IJ