Mentor

Ayush Vasudeva

Career Consultation

Senior Global Validation Engineer with 6+ years of experience across medical device and pharmaceutical manufacturing, specializing in complex validation programs (Equipment Qualification, Process Validation, Injection Moulding, MES).

Experienced in leading validation deliverables across URS, DQ, FAT, SAT, IQ/OQ/PQ, TMV, process development, asset decommissioning (assembly lines, moulding tools, lab equipment) and technology transfer activities within highly regulated environments. Proven track record in driving Data Integrity initiatives aligned with FDA 21 CFR Part 11, EU Annex 11, and WHO expectations, while supporting NPI, manufacturing optimization, and quality system improvements.

Skilled in quality engineering, risk management (pFMEA/dFMEA), CAPA, change control, CSV, MES/automation validation, and cross-functional project leadership. Experienced in leveraging Power BI and data analytics to drive operational performance, compliance, and continuous improvement.

Lean Six Sigma Green Belt and Google Project Management certified, with a passion for validation excellence, regulatory compliance, and delivering innovative healthcare technologies to patients.

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