Job Title: Validation and Qualification Technician
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Location: Cuautitlán, Mexico
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Work Model: On-site
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Contract Type: Permanent
About the Position
The quality control support department is responsible for ensuring the reliability of analytical and microbiological results through the maintenance, qualification, and maintenance of the validated/qualified status of equipment, analytical methods, sampling techniques, stability programs, budget management, outsourced laboratories, laboratory material suppliers, etc.
This position reports directly to the quality control support manager and indirectly to the quality control director, physicochemical laboratory manager, and microbiology and immunology laboratory manager. Ready to get started?
Join a global network that drives the way 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 R&D-driven biopharmaceutical company powered by AI, committed to improving people's lives and delivering compelling growth. Our deep understanding of the immune system and innovative pipeline enable us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we pursue the miracles of science to improve people's lives.
Key Responsibilities
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Execute and document equipment maintenance and qualification protocols, including protocol writing/review, reports, risk assessments, and traceability matrices
• Perform preventive and corrective maintenance of laboratory equipment and systems to ensure optimal performance and minimize downtime
• Manage quality documentation including deviations, non-conformities, corrective actions, and change controls with validation experience
• Ensure regulatory compliance with regulatory requirements (FDA, EMA) and company quality standards in all activities
• Collaborate with interdisciplinary teams (external suppliers, engineers, other departments) to ensure smooth execution of validation activities
• Report quality and HSE events to the manager in a timely manner for appropriate investigation and impact assessment
• Maintain accurate records of all activities and identify opportunities for continuous improvement in maintenance and qualification processes
About You
Experience:
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Experience in pharmaceutical industry laboratories or regulated sectors.
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Knowledge of laboratory equipment qualification, analytical methodologies, and quality systems.
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Experience working under safety standards and compliance with GLP, GCP, and GMP.
Soft and Technical Skills:
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Attention to detail and focus on quality and compliance.
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Ability to manage technical and regulatory documentation.
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Ability to work collaboratively in multidisciplinary teams.
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Continuous improvement mindset and problem-solving.
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Knowledge of Good Documentation Practices (GDP).
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Proficiency in the Mexican Pharmacopoeia.
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Knowledge of current NOM-059-SSA1 (Good Manufacturing Practices).
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Knowledge of current NOM-073-SSA1 (Drug and Medication Stability).
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Knowledge of current NOM-087-SEMARNAT-SSA1 (Environmental Protection and Environmental Health).
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Desirable knowledge of global pharmacopeias, including European Pharmacopoeia and USP.
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Desirable experience in microbiological, physicochemical, and immunological analyses.
Education:
- Bachelor's degree in Pharmaceutical Chemistry Biology (QFB), Chemical Biology Parasitology (QBP), Biochemical Engineering, or related careers in the pharmaceutical industry.
Languages:
- Intermediate English.
Why Choose Us
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Bring the miracles of science to life alongside a supportive team focused on the future.
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Discover endless opportunities to develop your talent and advance your career, whether through promotion or lateral movement, locally or internationally.
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Enjoy a well-designed and thoughtful benefits package that recognizes your contribution and amplifies your impact.
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Shape the future of medicine and vaccine distribution with cutting-edge technology, ensuring smooth launches and a resilient global supply chain.
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Drive industry-leading performance by leveraging digital innovation, data, and artificial intelligence, with speed and at scale.
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Transform lives around the world by delivering life-changing treatments anywhere and 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 pursue 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, disability, or gender identity. Check out our ALL IN video and learn about our Diversity, Equity, and Inclusion actions at sanofi.com!
#LI-LAT #LI-Onsite
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!