Senior Process Design Engineer

Summary

Our client is a biopharmaceutical company in Dublin looking for a Senior Process Design Engineer who will be responsible for supporting Drug Substance manufacturing processes at the site. The candidate will work as part of the site Process Engineering team and be responsible for the technical aspects of Drug Substance manufacturing Key deliverables.

Responsibilities

• Responsibility for providing technical input on prospective New Product Introductions into the Manufacturing Facility
• Responsible for providing technical support through all phases of the product cycle, including technology transfer, process scale-up, process validation and routine commercial manufacturing.
• Working cross-functionally with internal operations, technical services, quality assurance, quality control, analytical sciences, global process development, regulatory affairs, and supply chain groups which all support the commercial products and processes.
• Collection, organisation, trending, and analysis (including statistical analysis) of GMP manufacturing data.
• The role will also require supporting major technical investigations across the manufacturing network as required.
• Working closely with site-based partners to troubleshoot and improve existing manufacturing processes.
• Analysing, assessing and implementing capacity improvements to enable the site to hit its takt and changeover targets.
• Successful candidate will be required to identify, scope and execute improvement projects, demonstrating initiative and a positive attitude to change.

Qualifications & Experience

• Bachelor's or Master's degree in Engineering (Chemical, Process, or related field).
• Professional Engineering Accreditation or Chartership (e.g., CEng, PE) - preferred.
• 8 to 12+ years of experience in engineering, capital project execution, or technical operations in a regulated industry (e.g., pharma, biotech, medical devices).
• Strong understanding of GMP, GxP, regulatory compliance, and validation practices (IQ/OQ/PQ).
• Project Management certification (e.g., PMP, PRINCE2) an advantage.
• Knowledge of Commissioning and Qualification (C&Q) practices and relevant industry guidelines (e.g., ISPE, ASTM E2500).
• Hands on experience in developing URSs, reviewing design deliverables, and leading FAT/SAT and validation activities.
• Demonstrated ability to lead cross functional technical teams and interface with suppliers, designers, and project stakeholders.