Senior Validation Engineer

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.

Core Duties and Responsibilities:

• 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.

Education & Qualifications Required:

• 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.

Please note, we do not require agency assistance with this role.