Shubham Samrutwar

Computer System Validation (CSV) Engineer with 5+ years of experience in pharmaceutical and life sciences industries. Experienced in end-to-end CSV lifecycle activities including GxP Assessment, URS, FRS, Risk Assessment, IQ/OQ/PQ, Traceability Matrix, Validation Summary Reports, and Periodic Reviews. Strong knowledge of GAMP 5, FDA 21 CFR Part 11, EU Annex 11, and computerized systems such as PLC, HMI, SCADA, BMS, and IPC.

Experienced in regulatory audit support and client-facing validation projects.

Junior Manager – Validation at Cleanstep Pharma and Engineering Solution (2025-09 – Present)

• Successfully executed CSV projects for multiple pharmaceutical manufacturing facilities while ensuring compliance with GAMP 5, FDA 21 CFR Part 11, and EU Annex 11 requirements.
• Execution and verification of validation activities as per approved VMPs and protocols.
• Validation of PLC, HMI, IPC, BMS, and other computerized systems in compliance with GAMP 5.
• Client interaction and audit readiness support for regulatory inspections.

Validation Engineer at Consip Consultancy Pvt. Ltd. (2023-11 – 2025-09)

• Executed end-to-end CSV lifecycle deliverables for production, packing, and QC laboratory systems.
• Authored and executed IQ, OQ, PQ protocols and prepared validation reports.
• Performed risk assessments, traceability matrix preparation, and user acceptance support.
• Utilized EVAL tool for protocol execution and documentation.
• Ensured compliance with GAMP 5, 21 CFR Part 11, and EU Annex 11.

Validation Engineer at Maktech Services LLP (2023-03 – 2023-11)

• Developed and executed validation protocols for computerized and equipment systems.
• Prepared URS, RA, IQ/OQ/PQ, TM, and VSR documents.
• Supported validation execution and documentation review activities.

Water System and Documentation Engineer at Lupin Ltd., MIHAN (2021-07 – 2023-02)

• Operation, monitoring, and sanitization of pharmaceutical water systems.
• SCADA monitoring, trend analysis, and audit trail review.
• Deviation investigation, CAPA implementation, and regulatory audit support.
• Preventive maintenance, calibration compliance, and GMP adherence.

Bachelor of Engineering in Electrical Engineering – RTMNU, Nagpur (2019)

Diploma in Electrical Engineering – MSBTE (2016)

SSC – State Board (2013)