Prashant Nekkanti

About Prashant Nekkanti

I am a Software Validation Engineer with 2+ years of hands-on experience supporting equipment, utility, process, cleaning, and computer system validation (CSV) across clinical and commercial pharmaceutical environments. I specialize in helping organizations maintain strong cGMP compliance, reduce validation risk, and ensure inspection-readiness.My experience spans IQ/OQ/PQ execution, developing VMPs, performing risk assessments (FMEA/HACCP), and managing change control across bioreactors, chromatography systems, autoclaves, HVAC, cleanrooms (ISO 7/8), and critical utilities. I work extensively with TrackWise/eQMS and ensure full 21 CFR Part 11 compliance for laboratory and manufacturing systems.I bring strong exposure to cleaning validation, environmental monitoring, data integrity (ALCOA+), GDP, and contamination-control programs. Throughout my roles, I’ve collaborated closely with QA, QC, Engineering, Manufacturing, and Regulatory teams to deliver on-time validation packets and support successful FDA, MHRA, and internal inspections.I am passionate about driving risk-based validation, improving documentation quality, and streamlining compliance processes that accelerate manufacturing readiness while maintaining regulatory robustness.If you’re looking for a validation professional who is detail-oriented, audit-ready, and committed to operational excellence, let’s connect.

Experience

1. Software Quality Validation Engineer

   Flex

   Mar 2026 — Present · Austin, TX, US

   Employer: Advantage Technical Inc.

Education

• Northern Illinois University

  Master's degree, Operations Management Information Systems

• GITAM Deemed University

  Bachelor of Technology, Computer Science