Shivani Chukka
Senior CSV Engineer | GxP Compliance | Validation Protocols, IQ/OQ, CAPA | 5 Yrs Experience
- Role
- Senior Validation Engineer at Clinvira Inc
- Location
- Memphis, TN, US
- LinkedIn followers
- 500 followers
About Shivani Chukka
Smartsheet Consultant with 6 years of experience building enterprise-grade Smartsheet…
Experience
Senior Validation Engineer
May 2024 — Present · Boston, MA, US
Driving end to end Computer System Validation (CSV) projects for clinical and laboratory systems in compliance with FDA, EMA, MHRA, GAMP 5, ICH Q9, and 21 CFR Part 11-Designed and executed validation master plans, risk assessments, and protocols, ensuring audit readiness and regulatory alignment-Developed automated regression & impact testing libraries (Python, SQL), cutting manual testing by 40% and improving repeatability-Validated audit trails, access controls, and system security configurations to safeguard data integrity-Coordinate UAT sessions and vendor qualification assessments to ensure system reliability and compliance-Supported regulatory inspections by compiling documentation packages and addressing auditor queries-Championed continuous improvement by introducing automated test execution frameworks and electronic validation management tools to streamline CSV processes.
Education
Bhoj Reddy Engineering College for Women (BRECW), Hyderabad
Bachelor of Technology - BTech
Christian Brothers University
Master of Science - MS
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