Commissioning & Qualification Engineer

agap2 is a European engineering and operational consulting group founded in 2005 and specialized in the industry. We work in the Pharma, Biotechnology, Medical Devices, Energy, Infrastructure, Transportation, Chemicals, and Information Technology sectors.   As a consultant, you will have to support our clients in the realization of their projects on site by bringing your expertise and your skills.   You are agile and eager to adapt to different work environments that will fuel your curiosity of seeing what’s behind closed doors of the biggest projects of our client’s portfolio. Commissioning & Qualification Engineer (C&Q) Your missions:   Contribute to the integration of new production equipment and utilities in a biotech/pharma/medtech environment: Creation of specifications (URS) and risk analyses (FMEA, FRA) Creation and review of the Validation Master Plan (VMP) Participate in the creation and writing of test protocols for commissioning and qualification: FAT/SAT/IQ/OQ/PQ according to GMP/MDR requirements Participate in commissioning FAT/SAT Perform installation and operational tests (IQ/OQ/PQ)   Your profile :   Engineering degree in biotechnology, pharmaceutical sciences, process engineering or industrial pharmacist (PharmD) Experience in process validation and equipment qualification in a GMP environment Good Manufacturing Practices Fluent in German and English Swiss or EU citizenship jidf51680cafr jit0415afr