Role OverviewJob Title: Validation Engineer (Hybrid)Location: CarlowAn exciting opportunity is available for a Validation Engineer to join a high-performing team within a cGMP-regulated manufacturing environment. This role will support key validation activities across advanced pharmaceutical manufacturing systems, requiring a proactive, detail-oriented, and technically strong professional.The position will focus on validation of critical systems and equipment, including isolators (filling, sterility, and material transfer), along with associated technologies such as HVAC, VHP, E-Beam, and depyrogenation systems.Key ResponsibilitiesAuthor, review, approve, and execute validation and qualification documentation in line with regulatory and internal standards.Lead and support cycle development and performance qualification (PQ) activities.Manage and execute change controls, deviations, and investigations.Troubleshoot and resolve technical issues during validation studies.Collaborate with Production, Quality, and Maintenance teams during validation execution.Perform root cause analysis using standard problem-solving tools to address system or equipment failures.Support continuous improvement initiatives using Lean Six Sigma methodologies.Act as a validation representative on cross-functional and global projects.Ensure full compliance with cGMP, regulatory standards, and company procedures.Support audit readiness, regulatory inspections, and submissions.Complete documentation, risk assessments, and CAPAs in a timely and compliant manner.Promote a strong safety and compliance culture across all activities.Experience, Knowledge & SkillsProven experience in a GMP manufacturing environment, ideally in validation or engineering roles.Strong expertise in equipment and process validation lifecycle.Experience with CTU equipment qualification and thermal mapping.Hands-on experience in deviation management and change control systems.Ability to lead technical projects and deliver results independently.Knowledge of automation and process monitoring systems (e.g., DeltaV, PI System) is advantageous.Strong understanding of regulatory requirements (EU, FDA, international standards).Excellent data analysis and problem-solving skills.Strong technical writing, reporting, and documentation skills.Proficiency in Microsoft Office and relevant engineering tools.Excellent communication and stakeholder management skills.Desirable ExperienceEquipment lifecycle and periodic validation.Sterile fill-finish processes and technologies.Autoclave/SIP and dry heat sterilisation validation.Isolator qualification and filter validation.Container closure validation.Cleaning validation.Temperature mapping and environmental control systems.Experience with vial and syringe processing technologies.Project Management certification or experience.QualificationsBachelor’s degree (or higher) in Engineering, Pharmaceutical, Chemical, or Biological Sciences or related discipline.Additional InformationAbility to work both independently and within cross-functional teams.Strong attention to detail with a focus on quality and compliance.Experience working in a fast-paced, regulated environment preferred.
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