Job title:Container Closure Integrity Testing Engineer/Scientist

• Location: attached to Gentilly/based in Le TRAIT
• Job type: Permanent, Full time

About the job

Within Global Device and Packaging Unit (GDPU), part of Manufacturing & Supply, the Center of Excellence Primary Container Development (COE - PCD) team in Vitry-sur-Seine is responsible of developing the primary container (syringe or vial platform) of every new Sanofi parenteral product. The Sanofi R&D pipeline is covering general medicine, special care and vaccines, including mRNA and gene therapy products. By choosing the right container for each product, the team ensures that each dose can be easily and safely administered directly by the patient of by a healthcare professional.

To characterize the primary packaging and select the right container a multitude of tests should be performed (mechanical resistance, integrity, functionality, dimensional, and analytical chemistry).

The Sanofi R&D pipeline offers new challenges to the primary container world like maintaining container closure integrity at deep cold storage or administration without silicon oil.

Main responsibilities:

• Act as a global SME (technical) for Container Closure Integrity Testing (CCIT) of primary packaging
• Accountable for writing, modification of Working Instruction, test method & test specification, protocols and reports
• Accountable of sample management (storage, destruction, documentary monitoring)
• Accountable for the preparation, execution and documentation of physical tests with medical devices and their components throughout the lifecycle of a device
• Accountable for development and validation of physical test methods and associate tools to test medical devices
• Support the manufacturer on medical device issues
• Accountable for the interpretation of test results and proposal of test method improvements
• Review internal and external test documentation for adherence to test procedures and international standards as well as GMP

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About you

Experience:

• Different experiences in technical development including pharmaceutical GMP -lab work, at best within an international environment

Soft skills:

• You are passionate by technical and experimental development, you enjoy working in team, in a multicultural and multifunctional environment. You have the ability necessary to analyse and resolve conflicts, inside the team or with external partners

Technical skills:

• Good knowledge in injectable packaging, especially in PFS, cartridge, vial and large volume device and their respective components (stopper, rod, needle, closure system, safety system) are necessary
• technical expertise about Closure Container Integrity Testing
• GxP laboratory work (quality procedures (EV, CAPA, CC, ER), sample management, equipment management, Testing, documentation)
• Sample preparation: fill& finish operations)

Education:

• Engineer degree in physics, chemistry, biophysics, material sciences, physical measurements applied to complex systems. An experience of 3 to 5 years would be advantageous

Languages:

• English fluent and French