Job Title: Validation Engineer
Location: Castlepollard, Co. Westmeath
We are delighted to be recruiting a Validation Engineer for our client, an industry leader in high-quality manufacturing of moulded plastics for the medical, automotive and home appliance sectors. This is a permanent position based on-site in Castlepollard, offering a fantastic opportunity for an experienced validation professional to further develop their career within a world-class, quality-focused environment.
A successful candidate will play a key role in supporting Quality Assurance activities, driving validation excellence, and ensuring compliance with ISO standards and regulatory requirements.
Key Responsibilities
•Write and execute validation protocols and reports for new product introductions and revalidations, including IQ, OQ, and PQ, ensuring full regulatory compliance (ISO 13485, .
•Conduct data analysis on validation results and provide informed recommendations based on statistical evaluation.
•Lead the qualification of new and existing manufacturing equipment, ensuring correct installation and optimal performance.
•Maintain full traceability and audit readiness of all validation documentation for internal, customer, and regulatory audits.
•Support the maintenance and continuous improvement of the Quality Management System (ISO 13485, ISO 9001), including creating and revising SOPs.
•Support product development activities, including trials, sampling, and production runs of new materials and products.
•Monitor vendor performance, issue NCMRs where required, and ensure appropriate controls to protect product quality.
•Manage and support investigations related to validation deviations, non-conformances, and CAPAs.
•Collaborate closely and contribute to the strength of the overall quality function.
Key requirements
•Bachelor's Degree in Science, Engineering, or a related discipline.
•Minimum 2 years' experience as a Validation Engineer in injection moulding, blow moulding, or medical device manufacturing. (A background in Quality Engineering is also applicable).
•Strong statistical analysis capability (Minitab), understanding of SPC, and excellent knowledge of validation methodologies.
•Strong attention to detail, problem-solving skills, and the ability to work both independently and as part of a wider team.
•Ideally, prior experience working within an ISO 13485 environment.