Yogi Patidar

Equipment Validation Engineer with 10+ years of experience in pharmaceutical and biotech environments, specializing in laboratory equipment qualification and compliance with cGxP, GMP, and GLP standards.

Professional Expertise

Strong background in Validation, CQV, QC, Metrology, and CSV activities, including URS development and full lifecycle qualification of facilities, utilities, equipment, and computerized systems. Skilled in impact assessments, IQ/OQ/PQ execution, requalification, testing and summary report development, and supporting investigations, deviations, CAPAs, SOPs, and audit readiness. Known for deep technical expertise in laboratory instruments, risk assessments, and regulatory compliance across GxP-regulated operations.

CSV Program Management: Skilled in managing the execution of Computer System Validation (CSV) programs, Computer System Validation (CSV) Expertise.

Professional Expertise

Strong background in Validation, CQV, QC, Metrology, and CSV activities, including URS development and full lifecycle qualification of facilities, utilities, equipment, and computerized systems. Skilled in impact assessments, IQ/OQ/PQ execution, requalification, testing and summary report development, and supporting investigations, deviations, CAPAs, SOPs, and audit readiness. Known for deep technical expertise in laboratory instruments, risk assessments, and regulatory compliance across GxP-regulated operations.

CSV Program Management: Skilled in managing the execution of Computer System Validation (CSV) programs, Computer System Validation (CSV) Expertise.

• Equipment Qualification of cGMP, GxP, GLP, 21 CFR Part 11, GDP, GCP, FDA Regulations compliance
• Validation lifecycle management
• Commissioning, Qualification & Validation (CQV)
• Maintain validation master plans and schedules
• GAMP 5 framework
• 21 CFR Part 11 compliance
• System risk assessments
• Validation Plans (VP)
• User Requirements Specifications (URS)
• Functional/Design Specifications (FS/DS)
• Requirements Traceability Matrix (RTM)
• Validation Summary Reports (VSR)
• Support deviations, CAPAs, and change control processes
• Computer System Validation (CSV)
• Project Leadership & Execution
• Data Integrity & ALCOA+ Principles
• Cross-Functional Collaboration (QA, QC, IT, Engineering)

Project Experience: Extensive experience with Serialization, Aggregation, Procal, LIMS, SDLC, and Equipment Software Projects for Computer System Validation.

I hold a Bachelor of Science degree in Engineering, which gave me strong fundamentals in mechanical and process systems, technical documentation, and analytical thinking. This education directly supports my experience in equipment validation, commissioning, qualification, and compliance within pharmaceutical and biotech environments.