_Le contenu du poste est libellé en anglais car il nécessite de nombreuses interactions avec nos filiales à l’international, l'anglais étant la langue de travail._ _This job offer is accessible to all, regardless of gender._ **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 ​ **_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 **Pursue** **_Progress_** **.** **Discover** **_Extraordinary_** 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. You can be one of those people. Chasing change, embracing new ideas and exploring all the opportunities we have to offer. Let’s pursue progress. And let’s discover 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. Watch our ALL IN video (https://www.youtube.com/watch?v=SkpDBZ-CJKw&t=67s) and check out our Diversity Equity and Inclusion actions at sanofi.com (https://www.sanofi.com/en/our-responsibility/equality-and-inclusiveness) ! \#LI-FRA \#LI-Hybrid **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 (https://www.youtube.com/watch?v=SkpDBZ-CJKw&t=67s) and check out our Diversity Equity and Inclusion actions at sanofi.com (https://www.sanofi.com/en/our-responsibility/equality-and-inclusiveness) ! Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions. With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting www.sanofi.com or via our movie We are Sanofi (https://youtu.be/96EwNjb1TLo) As an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live. All in for Diversity, Equity and Inclusion at Sanofi - YouTube (http://www.youtube.com/watch?v=SkpDBZ-CJKw&t=2s)