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.
Job Description
* Develop and execute process validation protocols and reports for new product introductions and revalidations due to process/material improvements utilizing scientific/technical knowledge.
* Design and implement solutions to sustain and improve the Quality Management System (QMS).
* Maintain and support compliance to ISO and regulatory standards.
* Participate in site change control, ensuring that all changes to validated processes are effectively identified and implemented.
* Generate risk assessments covering cleaning, validation, and process.
* Review and execute Factory Acceptance Testing and Site Acceptance Testing protocols.
* Support Good Manufacturing Practice (GMP) and regulatory audits.
* Prepare and deliver training modules as required.
* Analyze data and make informed decisions/recommendations based on conclusions reached from data analysis.
* Support continuous improvement through Lean Six Sigma methodologies.
* Develop and execute change controls.
* Perform root cause analysis of system failures/substandard performance using standard tools and methods.
* Implement corrective action through the change management system.
* Collaborate with cross-functional teams, including liaising with vendors on projects.
Requirements
* Hold a third-level qualification in Engineering, Polymer Science, or equivalent Manufacturing experience.
* Have experience in statistical analysis/Minitab/SPC/validations.
* Possess excellent interpersonal, communication, influencing, and facilitation skills.
* Have experience as a Validation Engineer within an Injection moulding or medical manufacturing environment (preferred).