Our client - a rapidly expanding medical device manufacturing facility in Longford requires a Validation Engineer. This is a unique opportunity to build your career with a global leader in its field. 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 or give me a call on 01.
Role
1. Write and execute process validation protocols and reports for new product introductions and revalidations due to process/material improvements utilizing scientific/technical knowledge.
2. Developing and implementing solutions to sustain and improve the QMS.
3. Maintain and support compliance to ISO and ISO systems standards.
4. Participate in the site change control, ensuring that all changes to validated processes are effectively identified and implemented.
5. Generation of risk assessments, covering cleaning, validation, and process.
6. Review and execution of Factory Acceptance Testing and Site Acceptance Testing protocols.
7. Directly supports GMP and regulatory audits.
8. Prepare and deliver training modules as required.
9. Perform data analysis and make informed decisions/recommendations around conclusions reached from data analysis.
10. Support continuous improvement through Lean Six Sigma methodologies.
11. Execution/development of change controls.
12. 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 why’s etc.
13. Implement subsequent corrective action through the change management system.
14. Participate/lead cross-functional teams including liaising with vendors on projects.
Requirements
1. Third level qualification in Engineering, Polymer Science, or equivalent Manufacturing experience.
2. Experience in statistical analysis (Minitab)/SPC/validations.
3. Excellent interpersonal, communication, influencing, and facilitation skills.
4. Experience as a Validation Engineer within an Injection moulding or medical manufacturing environment preferred.
#J-18808-Ljbffr