Lucky Kumar
CSV / PLC Validation professional with 4+ years of experience
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About
Experienced Computer System Validation (CSV) and PLC Validation professional with 4+ years of experience in pharmaceutical, engineering, and automation industries. Skilled in validation documentation, gap assessment, PLC validation, and compliance with ISPE GAMP 5 and 21 CFR Part 11 requirements. Hands-on experience with production, engineering, laboratory, and utility systems across multiple pharmaceutical manufacturing sites.
Strong knowledge of validation lifecycle activities, SOP preparation, protocol execution, review, and regulatory compliance. A dedicated professional with excellent analytical, documentation, and teamwork skills, committed to delivering quality-driven validation solutions.
Experience
WORK EXPERIENCE
Executive – CSV
Swasti Solutions | October 2024 – Present
Perform Computer System Validation (CSV) and PLC validation activities for pharmaceutical and industrial automation systems.
Prepare, review, and execute validation documents including URS, FS, DS, IQ, OQ, PQ, RTM, and Validation Reports.
Ensure compliance with ISPE GAMP 5, 21 CFR Part 11, and GxP requirements.
Conduct risk assessments, gap assessments, and change control activities.
Support qualification and validation of production, utility, and laboratory systems.
Validation Engineer – PLC/CSV Validation
Air Care Zone, Indore | January 2022 – September 2024
Executed PLC and CSV validation projects for pharmaceutical manufacturing facilities.
Prepared and reviewed validation protocols, reports, and SOPs.
Performed system assessments, testing, and documentation review.
Worked on production equipment, utility systems, and laboratory software validation.
Coordinated with clients and cross-functional teams for project execution and compliance.
Junior Executive – PLC/CSV Validation
Oorja Technical Service Pvt. Ltd., Indore | April 2021 – December 2021
Assisted in PLC and CSV validation activities for pharmaceutical projects.
Supported IQ, OQ, and PQ execution and documentation.
Participated in system testing, data verification, and report preparation.
Maintained validation records and ensured compliance with company procedures and regulatory standards.
Education
Bachelor of Engineering (B.E.) – Electronics & Communication Engineering
Sagar Institute of Research & Technology, Indore (Affiliated to RGPV University)
Year of Passing: 2020
Percentage: 74%
Higher Secondary (12th Standard)
Bihar School Examination Board (BSEB), Patna
Year of Passing: 2016
Percentage: 63.2%
Secondary School (10th Standard)
Bihar School Examination Board (BSEB), Patna
Year of Passing: 2014
Percentage: 73.2%
