Validation Engineer
- Longford
- €62,500-65,000 per year
- Permanent
- Full-time
- A competitive salary-up to 65k DOE
- Pension Scheme
- Health Insurance
- Bonus structure
- Do you have 2+ years' experience in Validation Engineering?
- Do you have experience working in New Product Development?
- Track record of working in a highly regulated Medical Device Manufacturing environment is essential.
- Knowledge and experience working to ISO Standards is required.
- Knowledge of Lean Six Sigma, Root Cause Analysis and CAPAs is essential.
- Write and monitor Quality & Validation protocol and standards.
- Develop and implement solutions to maintain and improve the QMS.
- 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 execute of Factory Acceptance Testing and Site Acceptance Testing protocols.
- Directly support GMP and regulatory audits.
- Perform data analysis
- Support continuous improvement through Lean Six Sigma methodologies.
- Execution / development of change controls.