Headline

Consultant - Computer System Validation @ EY

About

Consultant in Computer System Validation (CSV) at EY with 6+ years of experience supporting validation and compliance of ERP, manufacturing, laboratory, quality, and IT infrastructure systems in GxP‑regulated environments. I lead end‑to‑end validation activities aligned with GAMP 5, 21 CFR Part 11, and EU Annex 11, including authoring and executing validation deliverables, conducting compliance and data integrity assessments, and supporting audit readiness. My experience covers SDLC‑ and Agile‑based validation approaches, discrepancy and defect management, lifecycle documentation, IT SOP preparation, and infrastructure qualification (IQ/OQ). I actively contribute to proof‑of‑concept initiatives for digital and optimized validation approaches, collaborating with global pharmaceutical, biotech, CDMO, and CRO clients. Currently pursuing a Bachelor of Computer Applications, with certifications in AI Engineering and Cybersecurity, I am focused on integrating technology, compliance, and efficiency within regulated IT and computerized systems.

Location

Pune District

AI stack

claude

gemini

ChatGPT

ChatGPT Images

Work experience

Consultant II - Computer System Validation at EY, Dec 2022 - Present · 3 yrs 10 mos, Pune District, Maharashtra, India, Responsibilities & Contributions: Lead Computer System Validation (CSV) activities for ERP, manufacturing, laboratory, quality, and IT infrastructure systems in GxP‑regulated environments. Author, review, and execute validation deliverables including URS, FRS, Configuration Specifications, Validation Plans, Risk Assessments, IQ/OQ protocols, Traceability Matrices, and Validation Summary Reports (VSRs). Prepare, review, and maintain IT SOPs governing validated systems, access management, change control, incident handling, and system operations. Perform IT infrastructure qualification (IQ/OQ) in alignment with GAMP 5 and regulatory expectations. Apply SDLC‑based and Agile validation methodologies, ensuring lifecycle compliance and continuous documentation maintenance. Conduct 21 CFR Part 11 and EU Annex 11 compliance, data integrity, and electronic records/signature (ER/ES) assessments. Drive discrepancy and defect management including Root Cause Analysis (RCA) and CAPA implementation. Support audit readiness and regulatory inspections (EMA, ANVISA, FDA) through documentation excellence and compliance traceability. Develop proof‑of‑concept (POC) initiatives for digital and optimized validation approaches. Collaborate with global pharmaceutical, biotech, CDMO, and CRO clients across multiple geographies.

Executive - Engineering Services Validation at Instrumentation-and-control-solution, Nov 2021 - Dec 2022 · 1 yr 2 mos, Chatrapati Sambhaji Nagar, Responsibilities & Contributions: Played a key role in validation of Laboratory Information Management Systems (LabWare LIMS) and QC software within pharmaceutical manufacturing environments. Drafted and executed IQ/OQ protocols and Validation Summary Reports for LIMS implementations and upgrades. Led test planning, script development, and execution for LabWare LIMS V7 modules including Sample Management, Instrument Interfacing, Environmental Monitoring, Stability, and Lot Management. Validated master data, workflows, interfaces, calculations, and reports, ensuring compliance with GxP and ALCOA+ principles. Supported Part 11 risk assessments, discrepancy investigations, and resolution. Conducted end‑user training and SOP walkthroughs, improving system adoption and audit readiness. Maintained end‑to‑end traceability from URS to PQ, ensuring data integrity throughout the system lifecycle.

Validation & Projects Engineer at SV Controltech India, Dec 2020 - Nov 2021 · 1 yr, Pune Division, Maharashtra, India, Contributed as a CSV Engineer supporting regulated system validation and remediation projects. Prepared validation deliverables in accordance with GAMP 5 guidelines. Performed 21 CFR Part 11 gap assessments and supported remediation activities for electronic records and signatures. Supported validation of systems across Quality Control, Production, and Engineering functions. Executed validation and testing for GxP‑regulated web applications used for data monitoring and control. Supported infrastructure and system qualification activities including IQ/OQ execution and documentation. Maintained compliance documentation supporting FDA, MHRA, and EU audit readiness.

Engineer-Technical Services at Precision Instrumentation and Services Pvt Ltd., Nov 2019 - Nov 2020 · 1 yr 1 mo, Nashik, Responsibilities & Contributions: Supported validation and qualification of SCADA, BMS, and EMS systems in GxP‑regulated pharmaceutical environments. Assisted in development and execution of IQ and OQ protocols. Performed testing of alarms, access controls, interlocks, and system functionality. Supported system verification, documentation control, and audit‑ready documentation practices. Gained foundational experience in instrumentation, automation systems, and regulated validation processes.

Education

Bachelor of Computer Applications, Computer Science and Information Technology, Jain (Deemed-to-be University)

Diploma, Instrumentation Engineering, Dr. Babasaheb Ambedkar Technological University