Validation IS Engineer

About the Role

As a Validation IS Engineer within our Validation team, you will contribute to ensuring the compliance and reliability of computerized systems that support the production of essential medicines, in a rapidly developing department. Ready to start?

Join Manufacturing & Supply and help reinvent how life-changing treatments reach patients. At the Le Trait site, the Computerized System Validation (VSI) department is strengthening to meet regulatory requirements and the digital transformation challenges of the site. You will take charge of a dedicated scope — MES or digital projects outside of MES — with real autonomy and management of external resources, within a cohesive and complementary team.

About Sanofi

Sanofi is a biopharmaceutical company that innovates in R&D and leverages AI at scale to improve people's lives and create long-term growth. Our deep understanding of the immune system – and our innovative pipeline – allows us to invent medicines and vaccines that treat and protect millions of people worldwide. Together, we pursue the miracles of science to improve people's lives.

Key Responsibilities

• Quality supervision of qualification and validation tasks in your domain.
• Prepare and review qualification and validation documentation, including protocols, test sheets, reports, risk assessments, and traceability matrices within predefined deadlines.
• Ensure appropriate documentation of deviations, non-conformities, and corrective actions.
• Guarantee adequate assessment (VSI expertise) of Change Controls.
• Ensure all qualification and validation activities comply with regulatory requirements (e.g., FDA, EMA) and company quality standards.
• Participate in internal and external audits and inspections, providing necessary documentation and support.
• Cooperate with cross-functional teams, including engineering, manufacturing, quality control, and project teams, to ensure smooth execution of validation activities.
• Provide qualification and validation expertise upon request.
• Identify opportunities for improvement in qualification and validation processes and contribute to continuous improvement initiatives.
• Report on your activities to contribute to departmental performance and ensure project deadlines within your scope are met.

About You

Experience:

• Experience in validation of computerized and/or automated systems in the pharmaceutical or biotechnology industry (GMP/cGMP)
• Knowledge of associated quality processes: change management, deviations, CAPA, and periodic reviews
• Experience in managing IS qualification and validation projects, including planning, execution, and documentation

Technical Skills:

• Solid understanding of regulatory requirements and guidelines (e.g., FDA, EMA) related to IS validation and qualification
• Ability to manage multiple validation projects simultaneously, ensuring they are completed on time and within budget
• Expertise in implementing risk assessments, analyzing validation data, and resolving deviations and non-conformities

Interpersonal Skills:

• Autonomy, rigor, and scientific mindset
• Ability to argue, persuade, and challenge one's own approaches with an open mind.
• Ability to manage multiple projects simultaneously within deadlines, including coordinating external resources

Education:

• Higher scientific degree (Master's level) or equivalent experience

Languages:

• English B2 level

Why Choose Us?

• Shape the future of pharmaceutical manufacturing by contributing to strategic digital projects (MES, LIMS, ERP) that concretely transform site operations.
• Transform lives by ensuring the compliance and quality of systems that support the production of essential medicines for patients worldwide.
• Grow in an environment where you can develop and make a real impact, with strong autonomy and concrete responsibilities from day one.
• Join a company that invests in its talent and technology, with opportunities for professional development and access to large-scale digital innovation.
• Become part of a team that is rapidly developing, with clear division of scopes (MES / non-MES digital projects) and management of external resources — a real lever for skill development.
• Benefit from a standard daytime schedule with the possibility of remote work.

Always Progressing. Discovering the Extraordinary.

Join Sanofi and enter a new era of science – where your journey can be as transformative as the work we do. We invest in you to go further, accelerate your thinking, and achieve what has never been done before. You will help push boundaries, challenge conventions, and design smarter solutions for the communities we serve. Ready to pursue the miracles of science and improve people's lives? Let's continue to progress and discover the extraordinary – together.

At Sanofi, we believe in equal opportunities, regardless of race, color, ancestry, religion, gender, origin, sexual orientation, age, citizenship, marital status, disability, gender identity, or any other characteristic protected by law.

Pursue progress, discover extraordinaryBetter 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!

The salary range for this position is :€42,400.00 - €56,533 Final compensation will be determined based on demonstrated experience, skills, location, and other relevant factors. Employees may be eligible to participate in Company employee benefit programs.