Shivani Kumar

Validation Engineer @Bionova Scientific

Fremont, CA, US

Lead project management activities for chromatography data system (CDS) upgrade, coordinating with cross-functional teams (QC, IT, Validation, QA) and external vendors. Schedule timelines, track deliverables, manage documentation, and identify critical path to ensure successful implementation.Support analytical tech transfer by assessing existing instrument qualification documentation, identifying tested parameter ranges, and contributing to documentation required for tech transfer and thaw processes.Perform and document qualification activities for analytical instruments in compliance with regulatory and internal standards, supporting GMP readiness and ongoing operations.Investigate and author deviations and CAPAs using MasterControl. Demonstrate strong technical writing skills to ensure clear root cause analysis, impact assessments, and effective corrective actions.

University of California, Davis

Bachelors

The Hong Kong University of Science and Technology

Study Abroad

University of California, Los Angeles

Master of Science - MS