Shamshi

Detail-oriented Computer System Validation (CSV) Engineer with 1.5+ years of hands-on experience executing end-to-end validation lifecycle activities (URS, IQ, OQ, PQ, VSR) for computerized systems in regulated pharmaceutical manufacturing environments. 1+ year of dedicated, specialized experience on ValGenesis VLMS (Validation Lifecycle Management System), an industry-leading platform used by top pharma companies.

Experience includes PLC Validation, SCADA Validation, Alarm Verification, Interlock Testing, I/O Verification, and Functional Testing across Production, Packaging, QC, and Engineering departments at 9+ pharmaceutical manufacturing sites for well-known organizations including Indoco Remedies, Unichem Laboratories, Zydus Lifesciences, USV, Mankind Pharma, and Emcure Pharmaceuticals. Strong working knowledge of 21 CFR Part 11, EU Annex 11, GAMP 5, GxP, GMP, and Data Integrity (ALCOA++) compliance frameworks. Committed to delivering accurate, audit-ready validation documentation that meets global regulatory standards.

Project Engineer – Computer System Validation - Arizona Automation & Technologies

(2024-12)

• Execute Computerized System Validation (CSV) activities for pharmaceutical manufacturing clients, ensuring full compliance with 21 CFR Part 11 and GAMP 5 regulatory standards.
• Author and execute validation protocols (URS, IQ, OQ, PQ, UAT) for computerized systems across Production, Packaging, QC, and Engineering departments.
• Perform automation system validation including PLC Validation, SCADA Validation, Alarm Verification, Interlock Testing, I/O Verification, and Functional Testing to confirm system performance against design specifications.
• Perform hands-on validation lifecycle management using ValGenesis VLMS, maintaining accurate and audit-ready electronic validation records.
• Prepare Traceability Matrices and Validation Summary Reports (VSR) to support regulatory audits and inspections.
• Apply Data Integrity and ALCOA++ principles throughout the validation lifecycle to ensure compliant, defensible documentation.
• Collaborate with cross-functional client teams (QA, Engineering, Production) at multiple pharmaceutical manufacturing sites to deliver validation projects on schedule.

Bachelor of Computer Application - Computer Application - ISBM University (2021 - 2024)

12th Science - Science - Project Central School, Kiriburu (2019 - 2019)

10th - Project Central School, Kiriburu (2017 - 2017)