Gopi N
Equipment & Process Validation Engineer | cGMP Compliance | WFI, RO, CIP/SIP, Bioreactors & Cleanroom Systems | Risk-Based Validation & Regulatory Expertise
- Role
- Equipment Validation Engineer at Teva Pharmaceuticals
- Location
- Edison, NJ, US
- LinkedIn followers
- 500 followers
Experience
Equipment Validation Engineer
Nov 2023 — Present · NJ, US
At Teva Pharmaceuticals, I drive the validation of critical pharmaceutical systems, including WFI generation and distribution, RO units, carbon filters, clean steam systems, and CO₂ incubators. I execute IQ, OQ, and PQ protocols, design risk-based validation strategies, and validate instrumentation and control systems (PLC, HMI, SCADA) to ensure operational excellence and regulatory compliance. My role includes developing SOPs, leading deviation investigations, implementing CAPAs, and supporting FDA, EU Annex 11, and cGMP-compliant inspections, ensuring systems remain fully validated and audit-ready.
Education
Jawaharlal Nehru Technological University
Bachelor's degree, Mechanical Engineering
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