Job Summary
Our 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 support the organization in achieving the new product introduction objectives.
Key Responsibilities
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. Develop and implement solutions to sustain and improve the QMS.
3. Maintain and support compliance with ISO 13485 and ISO 14001 standards.
4. Participate in site change control processes, ensuring all changes to validated processes are effectively identified and implemented.
5. Generate risk assessments covering cleaning, validation, and process.
6. Review and execute Factory Acceptance Testing and Site Acceptance Testing protocols.
7. Support GMP and regulatory audits.
8. Prepare and deliver training modules as required.
9. Perform data analysis and make informed decisions and recommendations based on data analysis.
10. Support continuous improvement initiatives using Lean Six Sigma methodologies.
11. Execute and develop change controls.
12. Perform root cause analysis of system failures and substandard performance using standard tools like FMEA, Fishbone diagrams, and 5 Whys.
13. Implement corrective actions through the change management system.
14. Participate in and lead cross-functional teams, including liaising with vendors on projects.
Qualifications & Key Attributes
1. Third-level qualification in Engineering, Polymer Science, or equivalent manufacturing experience.
2. Experience in statistical analysis (Minitab), SPC, and validations.
3. Excellent interpersonal, communication, influencing, and facilitation skills.
4. A minimum of 2 years' experience as a Validation Engineer within an injection moulding or medical manufacturing environment.
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