Validation Engineer

Job Description Be the Validation Expert Behind Safe, Compliant Pharmaceutical Manufacturing Validation Engineer What if your validation expertise could help ensure pharmaceutical manufacturing equipment operates safely, reliably and in full compliance with GMP standards? This is an opportunity to join a highly regulated pharmaceutical manufacturing environment, supporting equipment qualification, sterilisation validation, cleaning validation and thermal mapping. You'll work closely with Engineering, Production, Maintenance and Quality teams across the validation lifecycle - from developing protocols and executing studies through to analysing data, troubleshooting issues and completing technical documentation. What you'll achieve Design, author, review and execute qualification and validation documentation. Develop and execute equipment qualification and Performance Qualification (PQ) studies. Lead sterilisation validation activities, including Autoclave and Steam-in-Place (SIP) systems. Perform equipment and cleaning validation activities. Conduct thermal mapping and cycle development studies. Develop Validation Master Plans, protocols, reports, SOPs and supporting technical documentation. Analyse validation data and prepare technical reports. Troubleshoot technical issues encountered during validation activities. Support change controls, deviation investigations and root cause analysis. Provide technical input into quality investigations and regulatory documentation. Collaborate with Production, Maintenance, Engineering and Quality teams. Represent Validation on cross-functional engineering and site projects. Support regulatory inspections, audits and GMP compliance activities. Complete risk assessments and support timely CAPA closure. Contribute to continuous improvement and Lean Six Sigma initiatives. Your edge (desired, not required) Bachelor's degree or equivalent qualification in Engineering, Pharmaceutical Sciences, Chemical Sciences, Biological Sciences or a related discipline. Previous experience in a GMP/cGMP pharmaceutical manufacturing environment. Strong experience in equipment qualification and validation. Hands-on experience in sterilisation validation. Experience with thermal mapping is essential. Experience with cleaning validation. Strong technical writing skills, particularly validation protocols, reports and SOPs. Experience managing deviations, investigations and change controls. Strong analytical, troubleshooting and problem-solving skills. Excellent communication and organisational skills. Ability to work independently and effectively across cross-functional teams. Experience with CTU qualification, validation lifecycle management or periodic validation would be advantageous. Knowledge of Autoclave, SIP, dry heat sterilisation, filter or container closure validation would be beneficial. Experience with isolator qualification or sterile fill-finish manufacturing would be advantageous. Exposure to vial and syringe processing technologies would be beneficial. Experience with DeltaV, PI System or other process monitoring systems would be desirable. Project Management or Lean Six Sigma experience would be advantageous. Experience supporting regulatory inspections or inspection readiness would be beneficial. Why this role matters Validation plays a critical role in ensuring pharmaceutical manufacturing systems consistently meet safety, quality and regulatory requirements. You'll gain hands-on experience across equipment qualification, sterilisation, cleaning validation and thermal mapping, while contributing to projects within a highly regulated manufacturing environment. For a Validation or CQV professional looking to strengthen their technical experience across sterile manufacturing technologies, this role offers the opportunity to work on critical validation projects and collaborate with experienced cross-functional teams. The next step for you If you're an experienced Validation Engineer, CQV Engineer, Equipment Validation Engineer, Sterilisation Validation Engineer or Pharmaceutical Validation Specialist looking for your next opportunity in Carlow, Ireland, we'd love to hear from you. Please send your CV to [email protected] or reach out to discuss the role further. All applications are treated in the strictest confidence. Next Generation Recruitment specialises in Supply Chain, Procurement, Engineering, Quality, Technical, Scientific, Manufacturing, and Operations recruitment across permanent, contract, and temporary positions. Your personal data will never be shared outside our organisation without your prior written consent.