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Alessandra Carvalho is an experienced project engineer currently working at Axis Biotec Brasil since July 2018, where responsibilities include leading and executing validation protocols and managing calibration planning and control. Prior to this role, Alessandra spent nearly eight years at Roche, starting as a validation intern and advancing to validation engineer, where key duties involved risk-based qualifications of equipment and systems, supporting equipment commissioning, and overseeing clean room certifications. Alessandra holds a Master's degree in Business Administration with a focus on Production and Maintenance Strategic Management from Universidade Federal Fluminense, a Master's in Project Management from the Federal University of Rio de Janeiro, and completed a University Extension in Air Conditioning Engineering at Instituto Militar de Engenharia. An exchange program was also pursued at Ulm University.