Bhargav V
Validation Engineer | FDA 21 CFR Part 11, ISO 13485, GAMP 5 | Equipment & Process Validation | CSV | QMS | Risk & Compliance
- Role
- Validation Engineer at Johnson & Johnson
- Location
- Hillsborough, NJ, US
- LinkedIn followers
- 500 followers
About Bhargav V
I’m a detail-oriented and results-driven Validation and Quality Engineering professional experienced in FDA-regulated medical device and pharmaceutical industries. My expertise spans Computer System Validation (CSV), Equipment & Process Qualification (IQ/OQ/PQ/PV), and Risk Management aligned with 21 CFR Part 11, ISO standards, and GAMP standards.I specialize in driving validation lifecycle management through digital platforms such as ValGenesis, Kneat, and Veeva Vault, ensuring audit readiness, compliance, and data integrity. I bring strong collaboration skills across R&D, QA, Manufacturing, and Supplier Quality teams, ensuring validated, robust, and compliant systems throughout their lifecycle.
Experience
Validation Engineer
Jan 2025 — Present · NJ, US
Lead equipment, process, and software validations (IQ/OQ/PQ/TMV) aligned with FDA and GAMP 5.• Develop Validation Master Plans and risk-based validation protocols using ValGenesis and Kneat.• Collaborate cross-functionally on DHF and Design Verification & Validation (V&V).• Perform statistical data analysis (Minitab, JMP) for PPAP and process validation.• Author validation and quality documentation ensuring full regulatory compliance.
Education
Indiana Institute of Technology
Master's degree, Information Technology
QIS College Of Engineering and Technology
Bachelor's degree, Mechanical Engineering
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