Validation Engineer

Job SummaryOur client, a privately owned Irish company based in Longford, is seeking to recruit an ambitious Validation Engineer. This is a hands-on role within a dynamic manufacturing environment. The Validation Engineer is responsible for supporting all validation activities associated with the successful qualification of new tools / product introduction, they will report to the Validation Engineer Manager and will support the organization to achieve the new product introduction objectives.Key ResponsibilitiesWrite and execute process validation protocols and reports for new product introductions and revalidations due to process /material improvements utilizing scientific / technical knowledgeDeveloping and implementing solutions to sustain and improve the QMSMaintain and support compliance to ISO 13485 and ISO 14001 systems standardsParticipate in the site change control, ensuring that all changes to validated processes are effectively identified and implementedGeneration of risk assessments, covering cleaning, validation, and processReview and execution of Factory Acceptance Testing and Site Acceptance Testing protocolsDirectly supports GMP and regulatory auditsPrepare and deliver training modules as requiredPerform data analysis and make informed decisions / recommendations around conclusions reached from data analysisSupport continuous improvement through Lean Six Sigma methodologiesExecution / development of change controlsPerform root cause analysis of system failures, substandard performance, using standard tools and methods, to resolve machine and system issues e.g., FMEA, Fishbone diagrams, 5 why’s etc.;Implement subsequent corrective action through the change management systemParticipate / lead cross functional teams including liaising with vendors on projectsQualifications & Key AttributesThird level qualification in Engineering, Polymer Science, or equivalent Manufacturing experienceExperience in statistical analysis (Minitab) / SPC / validationsExcellent interpersonal, communication, influencing, and facilitation skillsA minimum of 2 years’ experience as a Validation Engineer within an Injection moulding or medical manufacturing environment