Bishal Bastola

About Bishal Bastola

Detail-oriented Validation Engineer with 11+ years of progressive experience leading Computer System Validation (CSV), equipment qualification, and lifecycle validation initiatives in FDA-regulated pharmaceutical and medical device environments. Deep expertise in 21 CFR Part 11, 210, 211, 820, Annex 11, GAMP5 risk-based methodologies, and Data Integrity (ALCOA+). Proven leader in commissioning, FAT/SAT, automation systems validation, deviation management, and regulatory inspection readiness.

Experience

1. Validation Engineer

   Bayer

   Jan 2021 — Present · Berkeley, CA, US

   Lead the qualification (IQ/OQ/PQ) of critical laboratory equipment, including freezers, refrigerators, and controlled temperature environments.• Author commissioning documentation and manage deviations and CAPAs.• Direct periodic reviews for equipment in use and manage the de-commissioning process for retired assets.• Manage root cause investigations and corrective action implementation.• Collaborate cross-functionally to support FDA inspection readiness.• Manage technical documentation through systems including ValGenesis, SAP, and LifeDoc, ensuring 100% adherence to Good Documentation Practices (GDP).• Execute root cause investigations for discrepancies and implement corrective actions via CAPA workflows.• Review and verify the Traceability matrix to check whether it has been updated regularly and tracing from URS FRS FS TS Test Scripts.• Schedule weekly meetings with lab technician(s) to ensure the physical parameters (such as temp. setpoint / low alarm limit / high alarm limit) of the freezers.

Education

• Pokhara Engineering College

  Bachelor's degree, Electrical and Electronics Engineering

  2008 — 2012