· You will assist and manage commissioning at different phases (start-up , qualification…) in compliance with contracts conditions and clients requirements;
· You will define the Qualification Approach;
· You will establish procedures for qualification in accordance with international standards (FDA, EMA, ICH, ASTM E2500, GAMP);
· You will write qualification documents;
· You will perform FAT/SAT and Equipment Commissioning;
· You will coordinate and execute qualification (IQ, OQ) tests;
· You will work in close collaboration with production, EHS, engineering, maintenance, QC, QA…;
· You will ensure handover with final users.
· Master degree in engineering (mechanical, electromechanical, automation, electrical, chemical or biochemical…);
· Native level of French or Dutch and fluent in English;
· At least 1 relevant experience in commissioning & Qualification;
· A previous experience in a GMP environment is a plus;
· Knowledge of Pharmaceutical Industry, Medical Devices, Biotechnology or Food technology;
· Good interpersonal communication skills, negotiation skills.
World leader in engineering and R&D services, Capgemini Engineering combines its broad industry knowledge and cutting-edge technologies in digital and software to support the convergence of the physical and digital worlds. Coupled with the capabilities of the rest of the Group, it helps clients to accelerate their journey towards Intelligent Industry. Capgemini Engineering has more than 55,000 engineer and scientist team members in over 30 countries across sectors including Aeronautics, Space, Defense, Naval, Automotive, Rail, Infrastructure & Transportation, Energy, Utilities & Chemicals, Life Sciences, Communications, Semiconductor & Electronics, Industrial & Consumer, Software & Internet.
Capgemini Engineering is an integral part of the Capgemini Group, a global leader in partnering with companies to transform and manage their business by harnessing the power of technology. The Group is guided every day by its purpose of unleashing human energy through technology for an inclusive and sustainable future. It is a responsible and diverse organization of over 340,000 team members in more than 50 countries. With its strong 55-year heritage and deep industry expertise, Capgemini is trusted by its clients to address the entire breadth of their business needs, from strategy and design to operations, fueled by the fast evolving and innovative world of cloud, data, AI, connectivity, software, digital engineering and platforms. The Group reported in 2021 global revenues of €18 billion.
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