Industrialization Engineer (FM)

The Industrialization Engineer Flow Kits contributes to the industrialization and transfer readiness of Flow Kit products by executing defined technical work packages and coordinating cross-functional activities to ensure products are translated into robust manufacturable validated and GMP-compliant production solutions at defined release milestones.

Grow with us - your responsabilities

• Contribute to design and process risk management by preparing and consolidating DFMEA/PFMEA inputs with quality and engineering stakeholders including functional analysis manufacturability considerations and Design-for-Manufacturing principles to ensure risks are assessed and tracked prior to transfer
• Support design verification activities by initiating and coordinating testing analyzing results and documenting technical rationales including validation of manufacturability assumptions and functional performance to confirm component selection and connection robustness
• Drive execution of assigned industrialization work packages including monitoring yield process stability manufacturability risks and tracking readiness milestones to ensure products meet defined technical quality and manufacturing requirements at release
• Confirm manufacturability process design assumptions & production requirements industrialization assumptions and Standards of Production during prototype and transfer phases including readiness reviews for production transfer to ensure stable and reproducible cleanroom production at defined release criteria
• Prepare validation assembly qualification and industrialization deliverables including definition and execution of process validation activities (e.g. IQ/OQ/PQ) by structuring technical documentation consolidating test results and aligning inputs from engineering quality and manufacturing to ensure validated compliant production approval
• Define and refine manufacturing and assembly processes including key process parameters and production conditions during industrialization and establishing target operating ranges for yield cycle time and process capability to ensure robust scalable repeatable manufacturing execution

What will convince us - your profile

• Masters Degree in Engineering Life Sciences or related technical field
• 3 years of experience in product development industrialization or production transfer in regulated or cleanroom environments
• Experience in design verification DFMEA/PFMEA and process validation (IQ/OQ/PQ) for complex products
• Knowledge of GMP quality management systems and manufacturing process definition (DfM / process parameters / validation)
• Structured analytical and problem-solving skills with strong process focus and documentation discipline
• Ability to collaborate in cross-functional and international teams with clear communication skills
• Fluent in English

About Sartorius

Sartorius is part of the solution in the fight against cancer dementia and many other diseases. Our technologies help translate scientific discoveries into real-world medicine faster so that new therapeutics can reach patients worldwide.

We look for ambitious team players and creative minds who want to contribute to this goal and advance their careers in a dynamic global environment.

Join our global team and become part of the solution. We are looking forward to receiving your application.
Experience:

IC