Senior Validation Engineer Cqv Csv Consultant

Mr. Kulkarni has over 15+ years of industry experience and throughout his career supporting Biotechnology and Pharmaceutical projects, he has actively led engineering, facility start-up activities and CQV activities throughout various phases in the Validation lifecycle. His experience includes developing and executing Commissioning, IOQ, Cycle Development, PQ protocols for Manufacturing equipment, Laboratory equipment, Utilities, and Process Automated Controls. He has experience with Distributed Control Systems particularly DeltaV, ABB 800xA, full CQV lifecycle activities, system reviews and audits, re-qualification activities, temperature mapping, and qualification of cleanrooms and laminar flow hoods. Mr. Kulkarni has worked closely with department managers in client audits to maintain compliance with industry regulations, good engineering practices and GAMP5 guidelines. His understanding of process automation, computer systems, and biotech and pharmaceutical manufacturing equipment allows Mr. Kulkarni to efficiently execute quality work and to also develop, manage and execute high level projects.