Role Purpose
A fantastic opportunity has arisen for an experienced Senior Validation Engineer to join a global leader in healthcare innovation at their world-class facility in Kilkenny.
This site is at the forefront of medical device manufacturing, producing life-changing technologies that help people live healthier, fuller lives.
This contracting position offers the chance to contribute to the development and manufacture of life-changing medical technologies that help people live healthier, fuller lives.
As a Senior Validation Engineer, you'll play a key role in ensuring the reliability and compliance of complex systems and processes — while leading, mentoring, and supporting a talented team of professionals in a dynamic, high-growth environment.
Duties
* Lead and coordinate validation activities across equipment, process, and system qualification.
* Develop and evaluate quality processes and standards to meet regulatory and internal requirements.
* Troubleshoot and investigate validation issues to identify root causes and drive effective solutions.
* Prepare, review, and approve validation documentation and technical reports.
* Partner with cross-functional teams to implement continuous improvement initiatives and best practices.
* Contribute to the establishment of validation policies, procedures, and long-term strategy.
Qualifications and Experience
* A third-level qualification in Engineering, Manufacturing, or a Science discipline.
* At least 5 years of experience in Engineering, Manufacturing, or a Scientific environment.
* 3–5 years of hands-on experience with process, equipment, facilities, or software validation in a regulated setting.
* Working knowledge of 21 CFR Part 820 and/or ISO 13485 standards (experience in pharmaceutical validation is also valued).
* Proven experience in developing or scaling new projects or manufacturing sites.
* Familiarity with the following documentation is highly desirable:
* User Requirements Specification (URS)
* Installation Qualification (IQ)
* Test Method Validation (TMV)
* Operational Qualification (OQ)
* Performance Qualification (PQ)
Why Apply?
This is an exciting chance to:
* Join a high-performing team within a cutting-edge medical technology organisation.
* Take ownership of impactful projects in a fast-paced, quality-driven environment.
* Be part of a company that values innovation, collaboration, and professional growth.