Job Overview
The Validation Engineer is a critical role within our organization, responsible for driving validation excellence and ensuring compliance with ISO standards and regulatory requirements.
* This position plays a key role in supporting Quality Assurance activities, including writing and executing validation protocols and reports for new product introductions and revalidations, ensuring full regulatory compliance (ISO 13485, etc.).
* The successful candidate will conduct data analysis on validation results and provide informed recommendations based on statistical evaluation.
* This position also involves leading the qualification of new and existing manufacturing equipment, ensuring correct installation and optimal performance.
* A strong focus on maintaining full traceability and audit readiness of all validation documentation for internal, customer, and regulatory audits is required.
* The ideal candidate will support the maintenance and continuous improvement of the Quality Management System (ISO 13485, ISO 9001), including creating and revising SOPs.
* This role requires collaboration with cross-functional teams to support product development activities, including trials, sampling, and production runs of new materials and products.
* The candidate will monitor vendor performance, issue NCMRs where required, and ensure appropriate controls to protect product quality.
* This position is also responsible for managing and supporting investigations related to validation deviations, non-conformances, and CAPAs.
Key Responsibilities:
* Write and execute validation protocols and reports.
* Conduct data analysis and provide informed recommendations.
* Lead the qualification of new and existing manufacturing equipment.
* Maintain full traceability and audit readiness of validation documentation.
* Support the maintenance and continuous improvement of the Quality Management System.
* Collaborate with cross-functional teams to support product development activities.
* Monitor vendor performance and ensure appropriate controls to protect product quality.
* Manage and support investigations related to validation deviations, non-conformances, and CAPAs.