Sri Rajne

Computer System Validation (CSV) Engineer with over 7 years of experience in validating GxP-regulated computerized systems across pharmaceutical and life sciences environments. Experienced in planning, executing, and documenting validation activities throughout the system lifecycle in compliance with FDA regulations, GAMP 5, 21 CFR Part 11, GMP, GLP, and Computer Software Assurance (CSA) principles. Skilled in authoring and executing validation documentation including Validation Plans, User Requirements Specifications (URS), Functional Specifications (FS), Risk Assessments, IQ/OQ/PQ Protocols, Requirements Traceability Matrices (RTM), Validation Summary Reports (VSR), and Change Control documentation.

Hands-on experience validating laboratory, manufacturing, quality, and enterprise applications including LIMS, QMS, ERP, EDMS, and cloud-based SaaS platforms. Strong experience collaborating with Quality Assurance, IT, Manufacturing, Engineering, Business System Owners, and external vendors to deliver compliant computerized systems. Adept at supporting software implementations, infrastructure upgrades, periodic reviews, audit readiness, and validation lifecycle management while ensuring data integrity and regulatory compliance.

Senior Computer System Validation Engineer at Heptroniks (2024-10 – Present)

Lead validation activities for GxP computerized systems supporting pharmaceutical manufacturing, laboratory, and quality operations.

• Develop Validation Plans, Risk Assessments, URS, IQ/OQ/PQ protocols, Traceability Matrices, and Validation Summary Reports for new implementations and system enhancements.
• Apply Computer Software Assurance (CSA) principles and risk-based validation methodologies to improve validation efficiency while maintaining regulatory compliance.
• Coordinate validation activities with Quality Assurance, Infrastructure, Business System Owners, Engineering, and third-party vendors.
• Validate cloud-hosted SaaS applications and support infrastructure qualification for regulated environments.
• Review validation deliverables prepared by junior validation engineers and provide technical guidance.
• Support software releases, application upgrades, periodic reviews, and change control activities.
• Participate in internal compliance audits and prepare validation documentation for regulatory inspections.
• Ensure validated systems comply with ALCOA+, 21 CFR Part 11, and company quality procedures.
• Mentor junior team members on validation documentation, testing practices, and GxP compliance.
• Successfully supported validation of multiple cloud-based quality systems with no critical audit observations.
• Reduced validation document review turnaround by introducing standardized validation templates and review checklists.
• Improved traceability and document consistency across validation projects through enhanced documentation practices.

Computer System Validation Engineer at Sermonix Pharmaceuticals (2023-08 – 2024-09)

Executed end-to-end validation activities for laboratory and enterprise computerized systems supporting clinical and manufacturing operations.

• Authored Validation Plans, URS, Risk Assessments, IQ/OQ/PQ protocols, and Validation Summary Reports.
• Performed functional, integration, and regression testing while documenting validation evidence according to company SOPs.
• Participated in system implementations, upgrades, and application enhancements.
• Assisted in validating electronic records and electronic signature functionality in compliance with 21 CFR Part 11.
• Collaborated with QA, Manufacturing, IT, and vendors to resolve validation issues and support project timelines.
• Supported change control assessments and validation impact analysis for software releases.
• Maintained traceability between business requirements and executed test cases.
• Assisted with internal audit preparation and validation documentation reviews.
• Completed validation deliverables for multiple application upgrades within scheduled project timelines.
• Contributed to successful implementation of standardized risk assessment templates adopted across the validation team.

Validation Analyst at Dr. Reddy's Laboratories Ltd. (2020-06 – 2022-12)

Performed validation activities for laboratory, manufacturing, and quality systems operating in GxP environments.

• Prepared IQ, OQ, and PQ protocols based on approved User Requirements and Functional Specifications.
• Executed validation testing and documented results according to validation procedures.
• Assisted in preparation of Validation Plans, SOPs, Risk Assessments, and Requirements Traceability Matrices.
• Supported software upgrades, periodic reviews, and system revalidation activities.
• Worked closely with IT and QA teams to resolve validation findings and documentation issues.
• Assisted in backup verification, disaster recovery testing, and infrastructure qualification.
• Participated in internal quality audits and addressed validation-related observations.
• Supported successful qualification of multiple laboratory systems with complete validation documentation.
• Improved protocol execution consistency through standardized testing templates and documentation reviews.

Validation Associate at Vital Synthetic Labs Pvt. Ltd. (2018-10 – 2020-05)

Assisted senior validation engineers in execution of IQ, OQ, and PQ protocols for computerized systems.

• Prepared validation documentation including test scripts, SOP updates, protocol execution records, and validation evidence.
• Supported User Requirement reviews and assisted in developing validation documentation.
• Executed test cases and documented defects during software validation activities.
• Assisted in maintaining controlled validation documents and ensuring compliance with document management procedures.
• Supported periodic reviews, change control documentation, and validation record management.
• Worked with Quality Assurance to resolve documentation discrepancies and validation observations.
• Participated in qualification of laboratory equipment software and computerized laboratory systems.
• Successfully supported validation documentation for multiple laboratory applications with zero major documentation deficiencies during internal quality reviews.
• Consistently delivered protocol execution and documentation within planned project schedules.

Master's in Health Informatics – University of Findlay