Laboratory Microbiological Equipment Qualification Engineer

Biological Equipment EngineerAgap2 is a European engineering and consulting group founded and specialized in industry. We work in the sectors of pharmaceuticals, biotechnology, medical devices, watchmaking, and mechanics. As a consultant, you will be responsible for supporting our clients in the management of their projects on-site by providing your expertise and skills. You are agile and eager to adapt to different working environments that will fuel your curiosity to see what lies behind the closed doors of the largest projects in our portfolio. Main missions:The consultant will work on the production site of one of our clients specialized in the manufacture of injectable medical devices based on biopolymers, in a GMP environment. You will draft and execute the qualification (IQ/OQ/PQ) protocols for microbiological equipment: autoclaves, microbiological safety cabinets (MSC), laminar flow hoods, incubators, and ventilated enclosures (MSC, HFL) according to ISO and NF EN standards. Participate in the monitoring of controlled environments (clean rooms): particulate counts, microbiological samples, trend monitoring, and update risk assessments related to qualified equipment (FMEA, FMECA).Manage the life cycle documentation of equipment: specifications, management reports, and CAPA. Ensure the metrological follow-up of measuring instruments (micropipettes, balances, pH-meters, particulate counting systems).Profile required:Engineering degree or equivalent in biotechnology, microbiology, process engineering, quality, or life sciences, or alternatively, a minimum of X years of experience in the field of medical devices or experience on microbiological equipment (autoclaves, MSC, incubators, enclosures). Proficient in the drafting of protocols and reports (IQ/OQ/PQ) as well as risk analysis. Proficiency in French and English, preferably Swiss or EU, or valid Swiss work permit. jid4bed273aen jit0310aen jpiy26aen