Qualification & Validation Engineer

Qualification & Validation Engineer (CSV)

• Location: Waterford, Ireland
• Job type: 23 month FTC

About the job

As a Qualification & Validation Engineer – Computerized System Validation (CSV), you’ll play a pivotal role in shaping and executing Sanofi’s validation strategy across our digital ecosystem. You’ll contribute to the development and implementation of robust computerized system validation approaches, ensuring we meet global regulatory expectations while driving operational efficiency.

In this critical position, you will be a key guardian of ongoing compliance throughout the Qualification & Validation (Q&V) lifecycle for both existing and new equipment, systems, and processes at Sanofi Ireland. Your work will directly support business continuity, quality excellence, and the reliable performance of our digital and automated systems.

Ready to make an impact?

Join a global network that powers how Sanofi delivers — seamlessly, purposefully, and at scale. In Manufacturing & Supply, you’ll help reimagine how life-changing treatments reach people everywhere, faster.

About Sanofi Waterford

For more than 20 years, our Waterford team has continued to grow and diversify to serve patients around the world. Today, a team of over 800 work together at a state-of-the-art biopharmaceutical and medical device campus. Recognised through multiple local and national awards, Sanofi Waterford offers flexible working and access to a world of opportunities to grow your career at one location. As well as attractive benefits, the team enjoy access to an onsite gym and medical centre that underpin a strong commitment to health and wellbeing.

Main responsibilities:

• Provide quality oversight for all validation activities – ensure equipment, systems, and processes are qualified and validated to the required standards.
• Prepare and review validation documentation – create and assess protocols, reports, and risk assessments, delivering clear, accurate documentation on time.
• Manage issues and corrective actions – document deviations, support investigations, and help drive effective corrective and preventive actions.
• Evaluate and approve changes – assess proposed changes to systems or processes to confirm they remain safe, compliant, and well‑controlled.
• Ensure regulatory and quality compliance – make sure validation activities meet all relevant regulatory expectations and internal quality standards.
• Support audits and inspections – provide complete documentation and validation expertise during internal and external reviews.
• Collaborate and improve processes – work with cross‑functional teams and identify opportunities to streamline and strengthen validation practices.

About you

• Degree in a science, IT, or engineering discipline (e.g., Chemistry, Microbiology, Chemical/Mechanical/Electrical Engineering).
• Demonstrable experience in computerized system validation within the pharmaceutical or biotechnology industry, including managing qualification and validation projects from planning to documentation.
• Strong technical skills, including work with GxP computerized systems; understanding of 21 CFR Part 11, EU Annex 11, and GAMP 5; and solid knowledge of ALCOA+ data‑integrity principles.
• Familiarity with diverse system types (MES, ERP, LIMS, QMS, etc.) and understanding of IT service management processes and software development methodologies.
• Excellent communication and influencing skills, working effectively across multifunctional teams.
• Highly motivated, adaptable, resilient, and pragmatic, with strong problem‑solving abilities.
• Strategic thinker with strong project‑management skills, able to balance compliance requirements with business needs and support change‑management activities.

Why choose us?

• Shape the future of medicine and vaccine delivery with cutting-edge technology, ensuring seamless launches and a resilient global supply.
• Power industry-leading performance by leveraging digital, data, and AI-driven innovation – at speed and scale.
• Help deliver 30+ new product launches by 2030, ensuring patients get treatments faster than ever.
• Develop new skills, explore cross-functional roles, and work in an environment that values growth and discovery.

Pursue Progress. Discover Extraordinary.

Join Sanofi and step into a new era of science - where your growth can be just as transformative as the work we do. We invest in you to reach further, think faster, and do what’s never-been-done-before. You’ll help push boundaries, challenge convention, and build smarter solutions that reach the communities we serve. Ready to chase the miracles of science and improve people’s lives? Let’s Pursue Progress and Discover Extraordinary – together.

At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity, protected veteran status or other characteristics protected by law.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!

#LI-EUR

Pursue progress, discover extraordinary

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!