Validation Engineer required for medical device manufacturing facility in Longford. Will support the successful qualification of new tools / product introduction on-site. Permanent role with benefits. If interested, do email an updated word copy of your CV Role *Write and execute process validation protocols and reports for new product introductions and revalidations due to process /material improvements utilizing scientific / technical knowledge. *Developing and implementing solutions to sustain and improve the QMS. *Maintain and support compliance to ISO 13485 and ISO 14001 systems standards. *Participate in the site change control, ensuring that all changes to validated processes are effectively identified and implemented. *Generation of risk assessments, covering cleaning, validation, and process. *Review and execution of Factory Acceptance Testing and Site Acceptance Testing protocols. *Directly supports GMP and regulatory audits. *Prepare and deliver training modules as required. *Perform data analysis and make informed decisions / recommendations around conclusions reached from data analysis *Support continuous improvement through Lean Six Sigma methodologies. *Execution / development of change controls. *Perform 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 whys etc.; *Implement subsequent corrective action through the change management system. *Participate / lead cross functional teams including liaising with vendors on projects. Requirements *Third level qualification in Engineering, Polymer Science, or equivalent Manufacturing experience. *Experience in statistical analysis (Minitab) / SPC / validations. *Excellent interpersonal, communication, influencing, and facilitation skills *Experience as a Validation Engineer within an Injection moulding or medical manufacturing environment. #LI-AM6 Skills: Protocols minitab statistical