Computer System Validation Specialist

Work Your Magic with us!

Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.

United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.

Your Role:

We are currently seeking an experienced Computer Systems Validation (CSV) Specialist to join our team in Livingston. This is a key role, responsible for leading the CSV strategy across the site and ensuring full compliance with GxP, FDA, and international regulatory standards.

You will be the site expert on computerised system validation, supporting the Validation Master Plan (VMP), advising cross-functional teams on CSV best practices, and leading initiatives for GMP software and hardware validation, including GAMP 5 and 21 CFR Part 11 compliance.

Key responsibilities include:

Develop and maintain CSV documentation in alignment with the site VMP and global procedures. Lead validation activities for new and existing GxP systems, including risk assessments, protocols (IQ/OQ/PQ), and test execution. Provide expert input during audits, inspections, and investigations (deviations, CAPAs). Collaborate closely with IT, QA, Manufacturing, and Engineering to ensure compliant system implementation. Monitor regulatory trends and ensure CSV practices align with current FDA, MHRA, ISO 13485, and ISO 9001 requirements. Own and continuously improve CSV SOPs, templates, and training programs.

Who You Are:

Bachelor’s Degree in a relevant scientific or technical field (e.g., Life Sciences, Computer Science, Engineering). Minimum 2 years’ experience in Computer Systems Validation in a GxP-regulated pharmaceutical, biotech, or medical device environment. In-depth knowledge of GAMP 5, 21 CFR Part 11, Data Integrity (ALCOA+) principles, and software lifecycle (SDLC). Proven track record in writing, reviewing, and executing CSV documentation (URS, FRS, IQ/OQ/PQ, traceability matrix, etc.). Strong working knowledge of quality systems, risk-based validation, and compliance frameworks. Excellent stakeholder communication and documentation skills.

What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!

Apply now and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity!