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Swapnil Gandhi, PhD, is a Senior QA Validation/Automation Compliance Consultant at FUJIFILM Diosynth Biotechnologies since October 2020, serving as a Subject Matter Expert in automation, bio-processes, equipment qualification, and compliance systems. Responsibilities include overseeing automation and validation activities to meet cGMP/GAMP guidelines, conducting detailed reviews of DeltaV automation, manufacturing bio-processes, and supporting significant initiatives such as the Operation Warp Speed Program for COVID-19 vaccine manufacturing. Prior experience includes roles as a biopharma consultant and QA consultant across various companies, focusing on automation qualification and validation, and engineering leadership at Pfizer and AbbVie. Swapnil holds a PhD in Chemical and Biochemical Engineering from the University of Iowa and has a strong background in research and teaching in chemical engineering, with publications and patent contributions in bioprocess optimization and drug delivery systems.