Senior Validation Engineer
CREGG Recruitment is currently working with a leading medical device company in Galway to hire a Senior Validation Engineer
Hybrid Model 1-2 days onsite
Call Breda 0860262157.
Working within the Quality and Reliability Engineering Teams, analyze the ability of product and production systems to comply with customer and contractual requirements through established reliability factors. They design, recommend revisions and install quality control systems, develop and document analytical methods for establishing reliability of products and their components and conduct analysis on relative reliability with regards to cost, structure, weight, maintainability, facility of production, and availability of materials and equipment.
- Generate validation documentation (URS, IQ, OQ, PQ and process characterisation studies & validation reports) and assist in the execution of protocols for equipment, process, utilities, methods and computerised systems.
- Troubleshoot validation issues associated with the validation project and provide feedback to the product/process design team.
- Ensure consistency on validation/qualification approach across systems and projects. Review and approve changes to equipment, process, utilities, methods and computerised systems to ensure the validation status of equipment is maintained.
- Ensure validation documents are up-to-date (primarily project MVPs and key inputs).
- Manage the execution of the product/process validation as per the MVP and project plan.
- Work directly with customer validation representatives to define inputs and requirements to the MVP.
- Ensure all results and data are correct and follow-up on any gaps or discrepancies.
- Liaise with the Engineering function to ensure that equipment validation requirements are maintained from Purchase to Qualification of new technology equipment.
- Level 8 degree in Science/Engineering.
- 5+ years’ experience in a similar role within the Medical Devices or related Healthcare industry.
- Strong knowledge of ISO and FDA quality requirements.
- Good understanding of validation concepts and documentation.
- Strong communication skills, including ability to advise and influence.