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, etc.).
- 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.
For a confidential discussion and more information on this Validation Engineer role in Castlepollard, please contact Jamie Fannon.
jamie.fannon@collinsmcnicholas.ie
090 645 0761
