Bhargavi Killi

I am a dedicated and results-driven Computer System Validation (CSV) engineer with a passion for ensuring the reliability and compliance of software systems in regulated industries.I am committed to ensuring that computerized systems operate flawlessly while mitigating risks and maintaining compliance throughout their lifecycle. My commitment to the CSV field stems from a genuine belief in the importance of safeguarding patient safety, data integrity, and product quality in regulated industries. I find fulfillment in overcoming complex challenges and contributing to the success of organizations that rely on validated systems to meet their mission-critical objectives.

I initially started working with vertex ventures as csv quality specialist from 2018 to 2019 on projects like LABWARE LIMS, ORACLE AERS during which I developed complete understanding on compliance with cGMP, GMP, and FDA regulations as well as of 21 CFR Part 11, along with FDA regulated environments. I also used HP ALM as a requirement management tool and involved in identifying the causes and implementing CAPA. I got an overview of how the master validation plans and qualification plans are made and executed. 

After vertex ventures I started working with Dr.reddy’s as CSV engineer from 2019 to 2022 during which I was predominantly involved in qualification and commissioning of facility system equipment like HVAC, WFI, Clean steam etc. I was also involved in development, execution, and documentation of validation protocols for computerized systems in compliance with GMP and also ensuring adherence to ALCOA (attributable, legible, contemporaneous, original, accurate) principles. Created test plans and used standardized templates for the IQ, OQ, and PQ, as well as traceability matrices, deviation forms, and validation summary reports. I also led multiple validation projects SAP, track wise, LIMS by following GAMP5, SOP and 21 CFR part 11 guidelines.

After Dr.Reddy’s I started working with PTC THERAPEUTICS as a CSV ENGINEER from 2023 where I was prominently involved in development IQ/OQ/PQ protocols of industrial label printers. I also analyzed Test Scripts to ensure compliance with 21 CFR part 11 regulations. I gained expertise in applying CQV principles to ensure compliance with regulatory standards and industry best practices. During this course of time I was also involved in Reviewing and approval of qualification protocols (IQ/OQ/PQ) for equipment and software, including bioreactors, SCADA, and chromatography systems,

Doctor of pharmacy : 2021

Masters in health informatics: 2023