Senior Engineering Manager, Process Validation Location: Dublin, Ireland (Hybrid) We are partnering with a leading global healthcare manufacturing organisation to recruit an experienced Senior Manager, Process Validation. This is a senior leadership role responsible for driving validation strategy and excellence across a global manufacturing network, ensuring compliance with GMP and industry regulations across equipment, facilities, utilities, automated systems, manufacturing processes, and cleaning validation. This role offers the opportunity to lead high-performing teams, influence global validation standards, and support the delivery of innovative manufacturing solutions within a highly regulated environment. Key Responsibilities

• Lead a globally dispersed Validation Engineering team, defining strategy, planning, and execution across multiple sites.
• Develop and implement validation strategies aligned with global technical operations.
• Oversee validation activities including equipment, facilities, utilities, automated systems, processes, and cleaning validation.
• Approve and review Validation Master Plans, protocols, and validation documentation (IQ, OQ, PQ, FAT, SAT).
• Drive standardisation and harmonisation of validation processes across global sites.
• Champion risk-based and science-driven validation approaches.
• Ensure ongoing compliance through periodic reviews and governance of validated systems.
• Support technology transfers, new product introductions, and process implementation.
• Partner with Quality, Engineering, Manufacturing, and cross-functional teams.
• Lead, coach, and develop a high-performing validation team.
• Support continuous improvement and Lean Sigma initiatives. About You You are an experienced validation leader with strong technical expertise in regulated manufacturing environments. Essential Requirements
• Degree in Engineering, Computer Science, or related discipline.
• 10+ years’ validation engineering experience in a cGMP environment.
• 10+ years’ experience in high-volume pharma or medical device manufacturing.
• Proven people management experience.
• Strong knowledge of EU GMP, ISO 13485, and FDA CFR Part 820.
• Experience across IQ/OQ/PQ and full validation lifecycle activities.
• Strong communication and stakeholder management skills.
• Ability to work in a matrix, multi-site environment.
• Willingness to travel (~5%). Desirable
• Plastics manufacturing experience
• CSV experience
• Lean / Continuous Improvement experience
• Electronic validation systems About the Opportunity This is a chance to join a globally recognised healthcare manufacturing organisation, shaping validation strategy at an international level while leading a skilled technical team and contributing to the delivery of high-quality, life-improving products. For further information on this Senior Engineering Manager Process Validation role in Dublin please contact Caroline Kingston on +353 868395531 or email caroline@hero.ie Check out all our open jobs on our HERO Recruitment website – https://www.hero.ie/. Please Note: Under its obligation under the Data Protection legislation, HERO Recruitment will not forward your details to any company without your prior approval. Data can only be transferred outside of the EEA based on standards contractual clauses, to a country for whom an adequacy decision has been given by the European Commission or where the express permission of the data subject has been given. You have supplied us with your personal data in the process of applying for a position. Our client company may have personnel outside of the EEA who will review your data. We will apply the appropriate criteria in respect of the data transfer depending on the location of those personnel.