Sathwik Reddy M

About Sathwik Reddy M

Computer Systems Validation (CSV) Engineer with over 6 years of experience in pharmaceutical, biotechnology, and medical device industries, specializing in validation of GxP-compliant computerized systems including LIMS, MES, ERP, SCADA, and analytical/lab equipment software. Skilled in overseeing the complete validation lifecycle—from planning and risk assessment to protocol execution, deviation management, and reporting— while ensuring compliance with 21 CFR Part 11, EU Annex 11, and GAMP 5 guidelines. Proven expertise in leading cross-functional validation initiatives, conducting impact and data integrity assessments, and supporting inspections and audits. Experienced in both Agile and Waterfall methodologies, delivering high-quality, compliant solutions within project timelines.

Experience

1. Senior Validation Engineer

   CriticalRiver Inc.

   Sep 2023 — Present · Pleasanton, CA, US

   Led Computer System Validation (CSV) efforts for GxP-compliant systems including Empower 3 CDS, LabWare LIMS, TrackWise QMS, and lab instrument software, ensuring adherence to GAMP 5, 21 CFR Part 11, and EU Annex 11. Developed Validation Master Plans (VMPs) aligning validation strategy with regulatory requirements and organizational quality standards.Prepared and executed IQ/OQ/PQ protocols for system implementations, upgrades, and periodic reviews of laboratory and enterprise applications. Authored and maintained URS, FRS, and Design Specifications (DS) to ensure traceability and support system validation lifecycle.Performed risk-based validation using FMEA and impact assessments to define scope and prioritize critical system components.Validated lab instrument software integrated with systems such as HPLC, GC, and FTIR, maintaining data integrity in line with ALCOA+ principles.

Education

• Gokaraju Rangaraju Institute of Engineering and Technology

  Bachelor's degree

• Trine University

  Master's degree, Information Science/Studies