Nikhila Vaddi

Sr Process Validation Engineer @Catalent

Winchester, KY, US

Currently working as a Senior Process Validation Engineer at Catalent Pharma Solutions, leading validation activities for aseptic fill-finish manufacturing projects. Responsible for designing and executing Process Performance Qualification (PPQ) protocols, supporting pre-filled syringe (PFS) fill line validation, and coordinating aseptic media fill studies. Collaborating with cross-functional teams including Quality, Engineering, and Manufacturing to support technology transfer and process scale-up. Ensuring compliance with cGMP, FDA, and EU GMP regulations while maintaining validation lifecycle documentation. Actively involved in deviation investigations, CAPA implementation, and risk assessments to ensure robust and compliant manufacturing processes.

Andhra University

Bachelor of Pharmacy - BPharm, Pharmaceutical Sciences