Job detail for Qualification and Validation Specialist

Job Title: Qualification and Validation Specialist

• Location: Ocoyoacac Plant, Mexico

• Work model: On-site

About the Job

As a Validation and Qualification Specialist within our Quality Control - M&S Vaccines Mexico team, you will be the guardian of the laboratory's technical integrity. You will lead the execution of qualifications and validations for equipment and instruments, ensuring that every piece of data generated is traceable, reliable, and compliant with the highest national and international regulatory standards. You will drive continuous improvement and be key in maintaining the laboratory's operational excellence under the Lean philosophy and Sanofi corporate guidelines. Ready to get started?

Join a global network that drives how Sanofi delivers its products, seamlessly, intentionally, and at scale. In M&S, you will help reimagine how life-changing treatments reach people everywhere, faster.

About Sanofi:

We are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve people's lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions.

Key :

• Comply with Good Manufacturing Practices and Good Laboratory Practices by following SOPs, directives, and standards to fulfill qualification and validation processes for analytical equipment.

• Prepare qualification/validation protocols and reports for analytical equipment aligned with international standards and Sanofi global requirements.

• Perform tests to qualify and validate analytical equipment, as well as verification tests to maintain the qualified/validated state.

• Perform the review and follow-up of the calibration/qualification of instruments/equipment used for the qualification/validation tests of the Quality Control laboratory's analytical equipment, through established plans and programs to ensure the validity of the analyses and/or results obtained from them.

• Review, request, and maintain the inventory of standards, supplies, and reagents required in the area for the qualification/validation of analytical equipment and ensure the analysis and delivery of results on time.

• Create, update, and maintain standard operating procedures by verifying pharmacopoeias, directives, and/or global site documents to keep them updated and current.

• Identify, evaluate, and control the significant Health, Safety, and Environment (HSE) and Good Practices (GxP) impacts/aspects and risks generated by your activities or processes, always seeking to generate the least amount and following the internal procedures at your disposal.

About You

• Experience: - Background in Quality Control laboratories within the pharmaceutical industry.

-Experience in laboratory equipment qualification (IQ, OQ, PQ) and analytical method validation.

-Practical knowledge in the preparation of qualification/validation protocols and reports.

-Participation in maintenance and calibration programs for laboratory equipment and instruments.

• Soft and technical skills:

• Expertise in Qualification and Validation: Solid knowledge in laboratory equipment qualification (IQ/OQ/PQ), analytical method validation, GMP, GLP, GDP, and handling of the Pharmacopoeia of the United Mexican States and regulations (NOM-059, NOM-073, NOM-087).

• Technical Laboratory Knowledge: Mastery of laboratory equipment, analytical methodologies (microbiological, physicochemical, and immunological), and global pharmacopoeias (European Pharmacopoeia/USP desirable).

• Orientation to Continuous Improvement and Compliance: Ability to drive Lean philosophy, propose process improvements, ensure compliance with SMS 2.0, and maintain data traceability and accuracy under integrity standards.

• Interpersonal and Collaboration Skills: Attention to detail, teamwork, active participation in HSE and organizational culture, and effective communication to prepare clear and precise technical documentation.

• Education: Bachelor's degree in Pharmaceutical Chemical Biologist (QFB), Bacteriologist Parasitologist Chemist (QBP), Biochemical Engineering (IB), Chemical Engineering (IQ), or a career related to the pharmaceutical industry.

• Languages: Intermediate - advanced level.

Why Choose Us

• Bring the miracles of science to life alongside a supportive and future-focused team.

• Discover endless opportunities to develop your talent and advance your career, whether through a promotion or a lateral move, locally or internationally.

• Enjoy a well-designed and thoughtful benefits package that recognizes your contribution and boosts your impact.

• Shape the future of medicine and vaccine distribution with cutting-edge technology, ensuring smooth launches and a resilient global supply chain.

• Drive industry-leading performance by leveraging digital innovation, data, and artificial intelligence, with speed and at scale.

• Transform lives around the world by delivering life-changing treatments anywhere, anytime.

Pursue Progress. Discover the Extraordinary.

Join Sanofi and enter a new era of science - where your growth can be as transformative as the work we do. We invest in you to go further, think faster, and do what has never been done before.

You will help push boundaries, challenge conventions, 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 the 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, ability, or gender identity. Watch our ALL IN video and check out our Diversity, Equity, and Inclusion actions at sanofi.com!

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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!