Qualification & Validation Specialist

Responsibilities

• Provide quality oversight of qualification and validation tasks for facilities, utilities, equipment, and computerized systems
• Prepare and review validation documentation including protocols, reports, risk assessments, and traceability matrices (IQ, OQ, PQ)
• Manage deviations, non-conformances, and corrective actions related to validation activities
• Evaluate change controls using validation expertise to ensure continued compliance
• Ensure all activities comply with regulatory requirements (FDA, EMA) and Sanofi quality standards
• Support internal and external audits and health authority inspections
• Collaborate with engineering, manufacturing, and quality control teams to drive timely execution of deliverables

Requirements

• Bachelor's degree in Science, Engineering, Pharmacy, or a related discipline
• 5-7 years of experience in pharmaceutical or biotechnology qualification and validation
• Strong knowledge of regulatory standards including FDA, EMA, and ICH
• Proficiency in validation documentation such as IQ, OQ, and PQ protocols
• Hands-on experience with risk management tools like FMEA
• Experience with deviation handling, CAPA management, and change control processes

Preferred Qualifications

• Experience in biologics or sterile/aseptic manufacturing environments
• Exposure to Health Authority inspections (HSA, FDA, EMA)
• Knowledge of data integrity principles (ALCOA+)
• Familiarity with paperless validation tools such as Kneat or Veeva

About the Company

Sanofi is a global healthcare leader that produces and delivers over 4 billion units of medicines and vaccines every year. We combine cutting-edge science with state-of-the-art facilities and AI-powered smart factories to ensure life-changing treatments reach patients faster, safer, and more sustainably.