Industrialization Engineer (F/M)

Sartorius AG; Aubagne; Sur place; EUR 52 000 - 68 000; Plein temps

Résumé du poste

Sartorius AG is seeking an Industrialization Engineer Flow Kits in Aubagne, France. You will support industrialization work packages, validate manufacturability, and coordinate cross‑functional activities to ensure robust, GMP‑compliant production solutions at transfer milestones.

Applicants should have a Master’s degree in engineering or life sciences, 3+ years in regulated environments, and experience with DFMEA/PFMEA, IQ/OQ/PQ and GMP knowledge. Fluency in English is required.

Qualifications

• Master’s Degree in Engineering, Life Sciences or related field.
• 3+ years in product development, industrialization or transfer in regulated/cleanroom environments.
• Experience in design verification, DFMEA/PFMEA and IQ/OQ/PQ.
• Knowledge of GMP and quality management systems.
• Structured analytical and problem-solving skills with strong documentation discipline.
• Ability to collaborate in cross-functional and international teams with clear communication in English.

Responsabilités

• Contribute to design and process risk management by preparing DFMEA/PFMEA inputs with quality and engineering stakeholders.
• Support design verification by coordinating testing and documenting technical rationales.
• Drive execution of industrialization work packages including yield and process stability tracking.
• Confirm manufacturability and production requirements during prototype and transfer phases.
• Prepare validation and industrialization deliverables including IQ/OQ/PQ testing and documentation.
• Define and refine manufacturing processes and target operating ranges for yield and cycle time.

Connaissances

Analytical thinking

Cross-functional collaboration

Documentation discipline

Problem-solving

English language proficiency

Formation

Master’s Degree in Engineering, Life Sciences or related field

Description du poste

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

• Master’s 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