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Job Description
Validation Engineer required for a rapidly expanding medical device manufacturing facility in Longford. The successful candidate will support the qualification of new tools and product introductions on-site.
Key Responsibilities:
- Write and execute process validation protocols and reports for new product introductions and revalidations.
- Develop and implement solutions to sustain and improve the Quality Management System.
- Maintain and support compliance to ISO 13485 and ISO 14001 systems standards.
- Participate in site change control and ensure effective implementation of changes to validated processes.
- Generate risk assessments covering cleaning, validation, and process.
- Review and execute Factory Acceptance Testing and Site Acceptance Testing protocols.
- Directly support Good Manufacturing Practice and regulatory audits.
- Prepare and deliver training modules as required.
- Perform data analysis and make informed decisions/recommendations.
- Support continuous improvement through Lean Six Sigma methodologies.
- Execute/develop change controls.
- Perform root cause analysis of system failures and substandard performance.
- Implement subsequent corrective action through the change management system.
- Participate/lead cross-functional teams and liaise 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 preferred.