58 QA engineer emplois trouvés

In this role, you will join our Manufacturing Operational Support (MOS) service.

You will be a key member of a team responsible for developing technical solutions, optimizing the Manufacturing platform, and integrating new molecules. You will act as a catalyst and facilitator for organizational and operational initiatives related to efficiency, productivity, reliability (obsolescence, technology watch), compliance, cost and energy considerations. This is an excellent opportunity to gain exposure to a wide variety of manufacturing techniques, including fed-batch, intensified, and continuous processes across different manufacturing suites and products (commercial and clinical).

• Participate in cross-functional projects and task forces, including the tech transfer of new molecules, implementation of new technology, continuous improvement, and major non-conformity investigations.
• Identify opportunities, build business cases, and promote the deployment of new technology.
• Ensure complete adoption of changes in the field in a tactful and diligent manner, monitor effectiveness, and ensure compliance with EHS and cGMP requirements (including management of change controls, corrective & preventive actions in the QMS system, writing and/or reviewing project charters, risk analysis, protocols, and reports as appropriate).
• Foster harmonization, synergies, and ensure consistency between different production units.
• Support the definition of design requirements (URS), testing, qualification, and documentation of project activities as required.

Your Profile:

• Strong knowledge in biotechnological processes, detailed manufacturing operations (including automated & execution systems, engineering designs, P&ID, etc.), and new technologies.
• Pragmatic, solution-oriented, and resilient with the ability to simplify complex technical processes or problems for different audiences.
• Experience working cross-functionally, interacting with various stakeholders (manufacturing teams on the floor, MSAT, QA, Engineering, EHS, etc.) in a team-based culture.
• Good communication skills, both written and oral. Fluency in French. English proficiency is a plus.
• Bachelor's or Master's degree in Biotechnology with initial experience in a cGMP biopharmaceutical environment (manufacturing, MSAT, or development functions) is desirable.
• This role offers an exciting opportunity for a motivated individual to grow and develop their skills within a dynamic and collaborative environment.