VIKRAM SWARNA
Justin,TX
Summary
- Validation Engineer with 7+years of experience across Computer System Validation (CSV), Equipment & Process Validation, Cleaning Validation, and Regulatory Compliance (FDA, MHRA, EMA), delivering audit-ready documentation and ensuring end-to-end compliance with global cGMP standards.
- Led Computer System Validation (CSV) activities in compliance with FDA 21 CFR Part 11, Annex 11, and GAMP 5, including authoring and executing URS, FRS, SDS, IQ, OQ, PQ, and validation reports.
- Validated GMP critical equipment such as autoclaves, SIP systems, freezers, and sterile filling line machinery, ensuring compliance with cGMP and data integrity standards.
- Conducted Commissioning, Qualification, and Validation (CQV) projects from DQ through PQ, delivering audit-ready documentation and meeting aggressive project timelines.
- Executed process validation protocols (PPQ) for sterile manufacturing processes, ensuring reproducibility, product quality, and adherence to global regulatory expectations.
- Performed cleaning validation studies, including LOD, LOQ, MACO calculations, and swab/rinse recovery testing, ensuring carryover risks met acceptance criteria.
- Authored and reviewed Validation Master Plans (VMPs), SOPs, Risk Assessments, and Validation Summary Reports to align site validation activities with regulatory standards.
- Hands-on experience with Kaye AVS Validators, Val-Probes, Data Tracers, and Kneat Gx for protocol execution, thermal mapping for validation documentation.
- Supported regulatory audits and inspections (FDA, MHRA, client audits) by providing inspection-ready documentation and timely responses to queries.
- Managed Change Controls, Deviations, and CAPAs, ensuring root cause analysis, corrective actions, and preventive measures were effectively implemented.
- Collaborated cross-functionally with QA, Manufacturing, Engineering, Regulatory, and IT to drive validation deliverables and ensure business continuity.
- Applied risk-based validation approaches to prioritize validation scope, reduce compliance risks, and improve operational efficiency.
- Delivered end-to-end validation lifecycle support across CSV, Equipment, Process, CQV, and Cleaning Validation, consistently ensuring compliance, data integrity, and timely project completion.
Overview
8
8
years of professional experience
Work History
Validation Engineer
Merck & Co. Pharmaceutical
Rahway, New Jersey
01.2024 - Current
- Authored and executed IQ, OQ, PQ protocols for GMP-critical systems, ensuring FDA and MHRA compliance.
- Executed computer system validation activities, authoring URS, FRS, and SDS to ensure compliance with Part 11 regulations.
- Developed and reviewed validation master plans, SOPs, and risk assessments to ensure compliance with FDA 21 CFR Part 11 and GAMP 5 standards.
- Led cleaning validation programs, calculating LOD, LOQ, and MACO to establish safe carryover limits in multiproduct facilities.
- Designed and validated sterilization wrapping/loading configurations to ensure effective steam penetration and MHRA compliance.
- Conducted thermal mapping studies using Kaye AVS validators and calibrated thermocouples to validate temperature uniformity.
- Managed CQV deliverables across utilities and process equipment from DQ through PQ phases with comprehensive traceability.
- Partnered with QA, manufacturing, regulatory affairs, and IT to align validation deliverables with compliance and business needs.
CSV Engineer
Johnson & Johnson
Raritan, New Jersey
10.2022 - 06.2023
- Executed computer system validation deliverables ensuring compliance with FDA 21 CFR Part 11 and GAMP 5 standards.
- Led IQ, OQ, PQ testing for sterilizers, SIP systems, freezers, and automated filling lines to verify functionality.
- Utilized Kneat GX for electronic protocol execution and real-time documentation to enhance audit readiness.
- Authored and reviewed validation protocols and summary reports, ensuring full traceability throughout validation lifecycle.
- Conducted FAT and SAT testing during commissioning to confirm system design functionality before production release.
- Performed electronic record and e-signature assessments to ensure compliance with data integrity requirements.
- Collaborated with QA, IT, engineering, and manufacturing teams to ensure CSV deliverables met regulatory expectations.
- Supported cleaning validation activities through swab/rinse recovery studies for multiproduct facilities.
Equipment Validation Engineer
Hetero Labs
Hyderabad, India
06.2018 - 05.2022
- Executed IQ, OQ, and PQ protocols for GMP-critical equipment to ensure compliance with cGMP standards.
- Conducted sterilization process qualifications for ETO and VHP sterilizers to align with ISO 11135 and ISO 14937.
- Performed gas sterilization validation studies confirming effectiveness through bioburden reduction and parametric release.
- Validated thermal equipment using Kaye AVS validators and calibrated thermocouples for accuracy and uniformity.
- Developed equipment lifecycle documentation, including URS, risk assessments, validation summary reports, enhancing regulatory compliance and validation processes.
- Supported cleaning validation activities by establishing scientifically justified MACO, LOD, LOQ acceptance limits, ensuring effective monitoring of cleaning processes.
- Collaborated during commissioning and qualification phases to ensure smooth transitions from FAT/SAT to PQ.
- Coordinated with QA, engineering, manufacturing, regulatory teams to align project timelines with compliance requirements, facilitating seamless project execution.
Education
Master's - Computer And Information Sciences
Southern Arkansas University
Magnolia, AR08-2023
Skills
Computer system validation
Software testing and validation
GxP compliance analysis
Risk assessment and management
Project validation planning
Installation qualification
Operational qualification
Performance qualification
IT infrastructure qualification
RPA bot testing
Change management strategies
Deviation management processes
CAPA implementation
Timeline
Validation Engineer
Merck & Co. Pharmaceutical
01.2024 - Current
CSV Engineer
Johnson & Johnson
10.2022 - 06.2023
Equipment Validation Engineer
Hetero Labs
06.2018 - 05.2022
Master's - Computer And Information Sciences
Southern Arkansas University