Ronak Modi

CSV Engineer with 5 years of experience validating regulated systems across GxP environments — from URS through IQ/OQ/PQ and Validation Summary Reports. Delivers 21 CFR Part 11, EU Annex 11, and GAMP 5 compliance through spreadsheet validation, risk assessment, V-Model execution, and audit-ready documentation. Skilled in defect tracking, manual testing, and cross-functional issue resolution across SDLC and STLC workflows, with a track record of on-time, compliant validation outcomes.

QA Validation Engineer - CIMCON InfoTech Pvt. Ltd. - Ahmedabad, Gujarat, India

(2024-08)

• Authoring and execution of end-to-end validation documentation and test protocols, including URS, Risk Assessments, Design Specification (DS), IQ/OQ/PQ protocols, Traceability Matrix (TM) and Validation Summary Reports in compliance with GxP standards.
• Performed spreadsheet validation per US FDA 21 CFR Part 11 and GAMP 5, ensuring data integrity and audit traceability across regulated systems.
• Utilizing Jira for tracking requirements, managing test cases, logging and resolving defects, and monitoring project progress throughout the Software Development Life Cycle (SDLC) and Software Testing Life Cycle (STLC) phases.
• Performed manual testing like Positive & Negative Testing, Regression Testing, along with defect tracking and reporting to ensure system functionality and quality.
• Investigate and resolve validation queries escalated by QA, pre-sales, and support teams.
• Collaborated with cross-functional teams to support project milestones, product improvement initiatives, identify and resolve validation issues throughout the product lifecycle.
• Managed project timelines and deliverables, ensuring alignment with company goals while maintaining high-quality standards.

Project Engineer - Tangent Technologies - Ahmedabad, Gujarat, India

(2021-10 - 2024-08)

• Led project planning and execution, ensuring alignment with client specifications and timelines.
• Collaborated with cross-functional teams to identify project risks and implement mitigation strategies.
• Managed multiple sites simultaneously, performed CSV qualification activities, and provided audit support to ensure regulatory compliance.
• Authored and reviewed comprehensive validation documentation including Gap Assessments, Validation Plans (VP), User Requirement Specifications (URS), Functional Requirement Specifications (FRS), Functional Risk Assessment (FRA) using FMEA, Design specification (DS), IQ, OQ, PQ Protocols, Traceability Matrices (TM) and Validation Summary Reports (VSR).
• Prepared and maintained validation documents and test scripts in compliance with CSV standards, and performed UAT activities throughout the system lifecycle.
• Worked with Change Control, Deviation Management, CAPA, and Periodic Review processes to support compliance in regulated GxP environments.
• Performed validation of enterprise and lab systems, PLC/SCADA systems, and automated manufacturing equipment within regulated GxP environments.

Testing Engineer - Mehta Cad Cam Pvt. Ltd. - Ahmedabad, Gujarat, India

(2020-09 - 2021-09)

• Inspected and tested electrical and electronic components — including CO₂ laser tubes, chillers, and power supplies — against functional and safety specifications.
• Identified defects and prepared detailed test and inspection reports, supporting continuous quality improvement.
• Reviewed electrical panels, wiring diagrams, and machine specifications prior to dispatch, ensuring compliance with design requirements.

Bachelor of Engineering - Instrumentation & Control - Gujarat Technological University (2016 - 2019)

Diploma Engineering - Instrumentation & Control - Gujarat Technological University (2013 - 2016)