Senior Validation Engineer

Prochem Engineering; Leinster; On-site; EUR 60,000 - 80,000; Full time

Job summary

A leading healthcare technology firm in Kilkenny is seeking a Senior Validation Engineer to ensure the reliability and compliance of systems. This role involves leading validation activities, troubleshooting issues, and working with cross-functional teams. Candidates should have a third-level qualification and at least 5 years of experience in relevant fields, including hands-on validation in a regulated environment.

Benefits

Cutting-edge technology

Professional growth opportunities

High-performing team environment

Qualifications

• At least 5 years of experience in Engineering, Manufacturing, or Scientific environment.
• 3–5 years of hands-on validation experience in a regulated setting.
• Familiarity with URS, IQ, TMV, OQ, PQ documentation.

Responsibilities

• Lead and coordinate validation activities across equipment, process, and system qualification.
• Develop and evaluate quality processes and standards.
• Troubleshoot validation issues to identify root causes.

Skills

Process validation

Equipment qualification

Troubleshooting skills

Team leadership

Quality assurance

Education

Third-level qualification in Engineering, Manufacturing, or Science

Tools

21 CFR Part 820

ISO 13485

Job description

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.