Qualification and Validation Engineer New - ref. s69109103

In this role, you will ensure that all equipment, systems, and processes meet cGMP standards and regulatory requirements, contributing directly to the success of our manufacturing operations.

Key responsibilities:

• Design, execute, and report on Process Performance Qualifications (PV/PPQ).
• Conduct validation studies for equipment, systems, and processes.
• Ensure all validation activities comply with Sanofi standards, cGMP, and regulatory requirements.
• Provide technical interpretation and guidance on FDA and EU validation requirements for aseptic processing, sterilisation, depyrogenation, and lyophilisation.
• Maintain validation documentation throughout the lifecycle and ensure equipment and systems remain compliant.
• Support site change control processes and participate in regulatory inspections.

What You Bring:

• 3-5 years’ experience in a healthcare manufacturing environment (pharmaceutical experience preferred).
• Degree in Science (Chemistry, Microbiology, Pharmacy) or Engineering (Chemical, Mechanical, Electrical).
• Strong technical knowledge of pharmaceutical plants, validation, and process development.
• Familiarity with cGMP, GAMP, ISPE, FDA/EU guidelines, and validation standards (AAMI/ANSI, PDA, ISO).
• Excellent problem-solving skills and the ability to troubleshoot validation challenges.
• Proficiency with MS Project, SPC packages, and an understanding of site KPIs is a plus.