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 ***** 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.