As part of our growth, we are seeking a Sr. Software Quality Engineer who will contribute significantly to the development of our automated and miniaturized cell therapy manufacturing factory on a bench. The primary focus of this position is to actively lead all quality and regulatory aspects of software developments enabling GMP & 21 CFR Part 11 compliance through daily test & validation of the team’s deliverables and implementation of the GAMP5 framework within an agile method. This is a multidisciplinary position, in close contact with researchers, pharmacists, and hardware and software engineers. The person who joins us will manage Quality throughout the product life cycle from product development and production builds to market release.

Candidates should enjoy working in a fast-paced, mission-driven environment, and be prepared to tackle a broad selection of challenges as the company grows. Candidates should be passionate, curious, great team players with the ability to work with minimal supervision.

Main Responsibilities:

• Guide the Software team in the implementation of regulatory standards such as 21 CFR Part 11, GMP Annex 11 & 22-IA

• Contribute to quality compliance efforts in alignment with applicable regulatory requirements

• Define, document, and continuously improve the software testing strategy, including manual, automated, integration, and end-to-end tests

• Collaborate closely with developers to ensure code is testable and meets quality expectations

• Ensure the design control (through GAMP5 Framework) processes defined by the Quality team are properly implemented and followed within the Software team

• In collaboration with the Quality team and end users / beta testers, collect and analyze feedback, report bugs and improvement opportunities to the Software team, and support their resolution

• Write, execute, and maintain functional test plans and test cases, including hands-on testing on the machine in collaboration with the Instrument team

• Participate in specification and code reviews to identify and mitigate quality risks early in the development process

• Define and monitor software quality metrics to support continuous improvement and compliance tracking

Required technical skills:

• Fluent in French, with professional proficiency in English (spoken and written)

• Degree in Computer Science, Software Engineering, or a related field

• Proven experience in software quality assurance within an agile development environment

• Prior experience in the medical or life sciences sector

• Familiarity with regulatory standards, including 21 CFR Part 11 and GMP Annex 11

• Knowledge of bug tracking and issue management tools (e.g., Jira, GitHub Issues)

Nice-to-have skills:

• Solid understanding of CI/CD pipelines (e.g., GitLabCI, GitHub Actions, Jenkins)

• Experience in API testing (REST, GraphQL) and integration testing

• Proficiency with automated testing tools such as Cypress, Playwright, Selenium, or Postman

• Working knowledge of a scripting or programming language

• Familiarity with tools such as SonarQube, Allure Report, or TestRail

• 1st interview with Manon (HR BP)

• Fit interview

• Technical interview

• Final interview with Anna (Head of People) and Jérémie (CEO)