Process & Project Delivery Engineer

Position Overview

Helsinn Birex Pharmaceuticals is recruiting a Process & Project Delivery Engineer to join their Engineering team in Greater Dublin. Reporting to the Engineering Manager, this role is central to executing capital projects, process engineering tasks, and manufacturing enhancements within a GMP-regulated pharmaceutical manufacturing setting. The engineer will collaborate extensively with Manufacturing Science & Technology (MSAT), Production, Quality, Validation, and Packaging teams to support process improvements, technology transfers, new product introductions, equipment upgrades, and capital investments. The role encompasses leading projects from initial concept through commissioning and operational handover while fostering continuous manufacturing improvements.

Key Responsibilities

• Collaborate closely with MSAT, Production, and Quality teams for process optimization, manufacturing scale-up, technology transfers, and introducing new products.
• Provide engineering assistance during equipment validation phases and commercial manufacturing runs.
• Develop and implement engineering solutions aimed at enhancing process capabilities, product quality, and overall manufacturing efficiency.
• Specify and choose pharmaceutical process equipment including vessels, mixers, pumps, filtration units, piping, and utility systems.
• Assist in troubleshooting manufacturing processes and equipment issues.
• Prepare, review, and maintain critical engineering documents such as User Requirement Specifications (URS), Functional Design Specifications (FDS), and design reviews.
• Participate in engineering investigations and conduct process risk assessments.
• Identify and apply continuous improvement initiatives throughout manufacturing operations.
• Lead capital projects from concept through commissioning to operational handover, managing project scope, budgets, schedules, and technical specifications.
• Coordinate procurement, installation, Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), commissioning, and qualification activities for equipment.
• Oversee suppliers, contractors, and external engineering partners to guarantee successful project completion.
• Track project progress, risks, budgets, and timelines, communicating updates to stakeholders.
• Ensure all projects comply with safety standards, timelines, budgets, and company protocols.
• Maintain adherence to GMP, Environmental Health and Safety (EHS), regulatory, and company policies in all engineering activities.
• Support validation, change control, and qualification processes.
• Take part in internal and external audits when required.
• Promote continuous improvements to boost manufacturing performance, reliability, and operational efficiency.
• Contribute to the advancement of engineering standards and best practice methodologies.

Required Qualifications and Experience

• Degree in Engineering or a related technical discipline; postgraduate qualifications in Engineering, Project Management or related fields are advantageous.
• Experience working in pharmaceutical, biotechnology, medical device, or other GMP-regulated manufacturing environments.
• Proven experience in Process Engineering, Project Engineering or Manufacturing Engineering roles.
• Track record of delivering capital projects, process improvements, equipment upgrades or manufacturing optimization initiatives.
• Knowledgeable in GMP, validation, commissioning, qualification, and change control procedures.
• Experienced in preparing engineering documentation including URS, FDS, technical specifications, and design reviews.
• Proven stakeholder management skills across Engineering, Operations, MSAT, Validation, Quality and external suppliers.
• Familiarity with pharmaceutical manufacturing equipment, and experience supporting packaging engineering projects is a plus.
• Experience with serialization systems, inspection systems, and packaging line enhancements is beneficial.
• Understanding of pharmaceutical process equipment, utilities, and manufacturing technologies.
• Comfortable working within cross-functional teams in a regulated manufacturing context.

Key Competencies

• Strong project management and organizational capabilities.
• Excellent technical problem-solving and analytical skills.
• Effective communication and stakeholder management proficiency.
• Ability to influence and work collaboratively with cross-functional teams.
• Results-driven with ability to manage multiple priorities effectively.
• High attention to detail along with commitment to quality and regulatory compliance.
• Continuous improvement mindset and passion for operational excellence.
• Capable of working independently while contributing as part of a team.