Job Description
We are seeking a seasoned Validation Engineer to support our operations in County Longford, Republic of Ireland. This role will be responsible for ensuring the successful qualification of new tools and product introduction by executing process validation protocols and reports.
The ideal candidate will possess a third-level qualification in Engineering, Polymer Science, or equivalent manufacturing experience, with a minimum of 2 years' experience as a Validation Engineer within an injection moulding or medical manufacturing environment.
Key Responsibilities:
1. Develop and implement solutions to sustain and improve our Quality Management System (QMS).
2. Maintain and support compliance to ISO 13485 and ISO 14001 systems standards.
3. Participate in site change control, ensuring all changes to validated processes are effectively identified and implemented.
4. Generate risk assessments, covering cleaning, validation, and process.
5. Review and execute Factory Acceptance Testing and Site Acceptance Testing protocols.
6. Support Good Manufacturing Practice (GMP) and regulatory audits.
7. Prepare and deliver training modules as required.
8. Perform data analysis and make informed decisions based on conclusions reached from data analysis.
9. Sponsor continuous improvement through Lean Six Sigma methodologies.
10. Implement corrective action through the change management system.
11. Collaborate with cross-functional teams, including vendors, on projects.
Required Skills and Qualifications:
* 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.
Benefits:
* A competitive salary package.
* An opportunity to work in a dynamic team environment.
* Professional development opportunities.