Validation Engineer - County Longford.
In this role you will be responsible for supporting all validation activities associated with the successful qualification of new tools / product introduction.
You will support the organisation to achieve new product introduction objectives.
Key Responsibilities: Write and execute process validation protocols and reports for new product introductions and re-validations due to process /material improvements utilising 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.
Interested applicants should have: 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 A minimum of 2 years experience as a Validation Engineer within an injection moulding or medical manufacturing environment.
Skills: validation engineer medical device injection moulding