Sartorius Stedim Biotech fournit des équipements, des consommables et des services pour le développement et la production de médicaments biologiques.
Industrialization Engineer (F/M)
Am I a fit — voir ma compatibilitéL’Industrialization Engineer Flow Kits contribue à l’industrialisation et au transfert de produits Flow Kit sur le site d’Aubagne. Il coordonne des activités techniques et transversales, notamment la validation des procédés, l’analyse des risques et la définition des processus de fabrication. Le poste requiert un master en ingénierie ou sciences de la vie, au moins trois ans d’expérience et un anglais courant.
Repères sur Sartorius Stedim Biotech
- Domaine officiel
- sartorius.com
- Offres ouvertes
- 15
Détails de l’offre
La description complète publiée par Sartorius Stedim Biotech.
Description de l’offre
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. Based at our Aubagne site, this role plays a key part in supporting Sartorius' mission of enabling better health for more people. Grow With Us –
Your Responsibilities
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
- 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 À propos de Sartorius Sartorius fait partie de la solution dans la lutte contre le cancer, la démence et de nombreuses autres maladies. Nos technologies permettent de traduire plus rapidement les découvertes scientifiques en médecine, afin que les patients du monde entier puissent accéder aux nouvelles thérapies. Nous cherchons des talents ambitieux et des esprits créatifs pour nous rejoindre sur cette voie. Des personnes qui souhaitent faire progresser leur carrière dans un environnement international dynamique. Vous aussi, faites partie de la solution! Nous attendons avec impatience votre candidature. www.sartorius.com/carriere
Prérequis
- design verification
- process validation
- manufacturing process definition
- structured analytical and problem-solving skills
- cross-functional collaboration