Vos responsabilités métier Produce and Review the URS in order to ensure all User requirements are fully respected Include all technical requests in the URS for the commissioning and qualification. Prepare Tender package and participate in discussions for supplier decision. Define the applicable standards/norms/engineering guidelines for the project Provide suppliers with the applicable standards Challenge technical solutions coming from suppliers Integrate safety, sustainability and green assessment in the design Define List of Deliverables for his/her discipline Provide project deliverables of his/her discipline to Process Lead Track supplier’s planning adherence for installation of systems. Progress report to be delivered to Process and technical lead Organize quality checks on field before each technical milestone activity Communicate the day to day schedule to the Process and Technical Leads Ensure a good communication with other stakeholders linked to its activity (Battery limits) Maintain his knowledge accuracy based on new technology. Keep up-to-date Write the specifications related with its area of expertise and provide the document to the Process Lead for review Define battery limit and RACI matrix with Process Lead Update drawings in its area of expertise Write commissioning documentation and ensure that the supplier's documentation is acceptable to perform verification (ASTM 2500) Perform FAT/SAT activities in its area of expertise Support the qualification phases after commissioning (V-Cycle and/or ASTM2500) Organize the training of the final user in its area of expertise & provide technical documentation in to finalize the hand-over Actively perfom the tasks to an efficient Hand-over in its area of expertise, with the follow-up of the associated punchlist Respect documentation strategy Qualifications 10+ years of relevant experience in large scale EPCMV Projects in the pharmaceutical industry In-depth technical experience in a regulated environment with knowledge of gene therapy, biologicals, pharmaceutical and engineering operations Good Expertise in automated systems within the large scale pharmaceutical industry Leading the Process & Automation team Large experience in basic/detailed design, equipment installation and commissioning Driving consistency within Engineering standards, norms and regulations Supporting qualification and validation activities Ensuring adherence to EHS regulation and Green good practices. Large Experience with EPCMV (Engineering, Procurement and Construction Management & Validation) contracting models is mandatory. Ability to lead package in collaboration with suppliers from design to qualified status. Ability to lead & review PED (Pressure Equipment Directive) is a relevant asset Ability to act as technical process expert during HAZOP (Hazard and Operability study) / QRA (Quality Risk Analysis) / FMEA Knowledge in qualification & validation approaches (ASTM E2500) is highly important Good technical knowledge in bioprocess equipment (USP, DSP, media/buffer) and their applicability. Good knowledge in automated systems (Siemens PCS7) and understanding of IT security requirements (data integrity) Strong knowledge of cGMP/GLP regulations, ICH, FDA CMC, ISPE and PDA Guidance Documents is preferred. Experience in large and complex projects as well as both formal and informal leadership / coordination Capable to benchmark with peers in the industry and able to identify latest trends Excellent communication skills in order to present frequent reports to Management.

Vos responsabilités métier : Participer à la conception et au développement de solutions logicielles intégrant à la fois des systèmes embarqués et leurs serveurs backend. Travailler sur des projets liés aux caméras connectées et au traitement de flux vidéo. Contribuer à l’implémentation de modules pour des environnements distribués. Assurer la communication entre différents systèmes en se basent sur différents protocoles. Participer à la rédaction de la documentation technique et au transfert de compétences aux équipes. Profil recherché Vos atouts pour réussir : Vous avez une expérience en IoT et une maîtrise des protocoles de communication IoT, notamment MQTT et ZMQ. Vous avez une maîtrise des solutions complexes mêlant vidéos, traitements de données et gestion de systèmes à faible consommation d'énergie Votre profil & personnalité : Issu(e) d’une formation Bac+5 cycle Ingénieur Vous justifiez d’une expérience de minimum 4 ans sur du développement C/C++ dans un environnement embarqué Vous êtes capable de sortir de votre zone de confort et d’être force de proposition dans un écosystème potentiellement complexe Vous êtes organisé.e et bon communiquant.e afin de transmettre la bonne information au bon interlocuteur