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