VSI / CSV Engineer (M/F)

European industry is transforming. The capital is there, the projects are too. But on the ground, the essential element is missing: the skills to run the lines. It is to respond to this context that Kali Group exists. We are a consulting firm 100% specialized in operational manufacturing. From industrialization to modernization, we solve the challenges imposed by factory complexity in Aeronautics, Nuclear, and Life Sciences. Our strength is our community. At Kali Group, every specialist is part of a collective of experts who share their feedback, methods, and solutions. You are never alone when facing a problem. When you are stuck on a subject, another member of the community has already solved it elsewhere. It is this collective intelligence that makes us different. Our ambition: To develop THE community of manufacturing specialists and become the European operational reference.

The position:

Join KALI GROUP, a company specialized in supporting life sciences projects. As part of the development of our activities, we are looking for a qualification/validation engineer (VSI/CSV) in the pharmaceutical and medical device industry in the Dijon (21) region.

Your missions: You are responsible for the qualification and validation of computerized systems used in pharmaceutical production and medical device processes, ensuring their compliance with global standards and international regulatory requirements.

In this capacity, you are in charge of: Performing Qualification and Validation of Computerized Systems (VSI) activities in accordance with current standards; Ensuring quality assurance and compliance of computerized systems in a regulated environment; Applying current frameworks and regulations; Intervening in a cleanroom environment and guaranteeing compliance with quality requirements; Updating technical documentation related to validation;

Profile sought:

Bring your skills: Holder of an engineering degree in pharmaceutical engineering, computer science, or equivalent, you have a minimum of 2 years of experience in VSI Qualification/Validation; Good knowledge of international regulations; Ability to operate in a demanding context with strong regulatory constraints; You speak English professionally (minimum B2).

Let's meet! You are actively searching or simply curious - If you recognize yourself in the missions and the profile, do not hesitate and apply. We can discuss your project and design your professional future together!