Sravan Voni
Foster City
Summary
Accomplished Lead CSV Engineer at Gilead Sciences with expertise in GxP compliance and risk assessment. Proven track record in developing validation documentation and ensuring data integrity. Adept at translating complex requirements into actionable plans while fostering collaboration across teams. Committed to maintaining high standards in regulatory environments.
Overview
9
9
years of professional experience
Work History
Lead CSV Engineer
Gilead Sciences
Foster City
07.2023 - Current
- Led end-to-end CSV activities for the implementation of LabWare LIMS ELN supporting regulated R&D and QC laboratories in a GxP environment.
- Defined and documented a risk-based validation strategy aligned with GAMP 5 (2nd Edition) and CSA principles, ensuring validation effort was commensurate with patient safety, product quality, and data integrity risk.
- Authored and executed the Validation Plan (VP) detailing system scope, validation approach, roles and responsibilities, deliverables, acceptance criteria, and release strategy.
- Translated laboratory workflows into functional and compliance-driven user requirements for ELN and LIMS.
- Assessed data lifecycle risks across ELN and LIMS, ensuring data integrity safeguards were effective.
- Analyzed system security and electronic signature functionality for Part 11 and Annex 11 compliance.
- Evaluated ELN–LIMS interfaces to confirm accuracy, completeness, and consistency of data transfer.
- Performed comprehensive GxP Impact Assessment to determine regulated functionality, data flows, and compliance scope.
- Conducted Data Integrity Risk Assessment ensuring adherence to ALCOA+ principles, including audit trail functionality, record retention, metadata capture, and system security.
- Executed Electronic Records and Electronic Signatures (ERES) assessment, confirming compliance with 21 CFR Part 11 and EU Annex 11 to uphold data integrity standards.
- Established and maintained a Requirements Traceability Matrix (RTM) linking URS to risk assessments, IQ/OQ/PQ test cases, and deviation management.
- Authored and executed Installation Qualification (IQ) verifying validated infrastructure, system installation, environment configuration, access control, and backup/restore mechanisms.
- Authored and executed Operational Qualification (OQ) focusing on critical ELN functionality including data entry, version control, audit trails, security roles, and electronic signatures.
- Facilitated Performance Qualification (PQ) and User Acceptance Testing (UAT) with laboratory end users to verify system performance.
- Managed validation discrepancies and deviations, performing root cause analysis and documenting resolution and impact assessments.
- Coordinated defect resolution with vendors and IT teams while maintaining validation state.
- Authored Validation Summary Report (VSR) summarizing validation execution, deviations, risk acceptance, and compliance justification to support regulatory review processes.
- Supported system release and go-live approval from CSV and Quality perspectives.
- Provided CSV support during QA review cycles and inspection readiness activities.
- Responded to FDA and internal audit inquiries, providing clear traceability and validation evidence.
- Ensured smooth transition to system lifecycle management and change control post go-live.
Sr. CSV Engineer
Cullinan Oncology
MA
10.2022 - 06.2023
- Created and developed the formal validation and test documentations – Validation Plan, Test plan, test activity road map, traceability matrix (posttest execution), Risk Assessment (Overall and Functional), ERES/21 CFR Part 11 assessment, Operational and Performance qualification test scripts, Test and Validation Summary Report.
- Developed combined CSV validation strategy, ensuring thorough assessment and validation of integration points between ELN and LIMS.
- Authored Validation Plans for both ELN and LIMS systems aligned with corporate CSV procedures.
- Conducted GxP Impact, Data Integrity, and ERES assessments for both systems and their interfaces.
- Performed interface risk assessment ensuring data transfer integrity between ELN and LIMS.
- Built and maintained separate and integrated RTMs to ensure full traceability across systems.
- Authored and executed IQ protocols verifying system installation, infrastructure, and validated environments.
- Authored and executed OQ protocols testing critical workflows, audit trails, role-based access, and exception handling.
- Analyzed the test data for dry run and formal test execution for functional and user acceptance testing for different phases.
- Reviewed URS, FRS, DS documents from validation/quality standpoint and provided feedback to the project teams.
- Worked on reviewing and updating the user acceptance testing scenarios and test scripts for formal test execution and promoted those for approvals using HP ALM.
- Developed the high level and detailed level process maps in defining the use cases for documenting the test scenarios and test scripts.
- Drafted and provided input on the mapping and configuration document, functional specifications, change management in user requirements prior to test execution.
- Reviewed Veeva and other vendors provided documentation to be included in the validation and testing strategy.
- Tracked and managed testing activities, including test preparation, execution, defect management, and status reporting using HPALM.
- Facilitated vendor meetings and communicated with project team members to ensure adherence to testing timelines.
Senior Validation Analyst
Johnson and Johnson
NJ
01.2019 - 07.2022
- Directed CSV activities for the initial rollout of an enterprise ELN (OpsTrakker) used to capture regulated laboratory data in GxP environments.
- Designed a right-sized validation model based on GAMP 5 and CSA guidance, ensuring risk and criticality drove validation effort.
- Developed and maintained the overall validation roadmap, documenting system boundaries, assumptions, deliverables, and release criteria.
- Partnered with laboratory leadership and Quality to translate business processes into clear, testable user requirements.
- Evaluated ELN usage scenarios for GxP relevance and compliance impact, ensuring alignment with regulated data types.
- Assessed system controls against ALCOA+ data integrity principles, focusing on traceability, auditability, and record lifecycle management.
- Reviewed electronic record and signature capabilities to confirm alignment with 21 CFR Part 11 and EU Annex 11 expectations.
- Created and controlled traceability artifacts linking requirements, risk classifications, verification activities, and outcomes.
- Assessed vendor-supplied documentation and testing evidence for regulatory reliance, confirming compliance and suitability.
- Verified system installation and configuration through installation qualification activities, including infrastructure and security controls.
- Challenged system functionality through operational testing, validating critical workflows, permissions, and audit trail behavior.
- Conducted user-driven qualification testing to validate laboratory processes.
- Investigated validation anomalies, documenting root cause and resolution to ensure adherence to CSV procedures and validate compliance.
- Worked with IT and the vendor to remediate defects without compromising validation integrity.
- Enabled Quality approval for system release and production use.
- Supported inspection readiness by ensuring validation artifacts were current, traceable, and defensible.
- Addressed auditor questions related to ELN validation strategy, data integrity, and compliance controls.
- Transitioned the ELN into validated operational status, including change control and ongoing compliance oversight.
Validation Analyst
Sun Pharma
India
04.2017 - 11.2018
- Reviewed and enhanced validation plan for PQ approach and strategy, ensuring compliance with GxP standards.
- Developed the user acceptance testing scripts and scenarios using HP ALM for dry run and formal execution of the various functionalities of the application.
- Facilitated communication to secure reviews and approvals for test scenarios and scripts before formal execution, streamlining the validation process.
- Developed and reviewed the test approach plan for the electronic trial master file used in clinical trials across various Study, Country, and Site level documents.
- Conducted requirement breakdown analysis of various SOP levels related to the clinical line through direct communication with subject matter experts across Europe and the US.
- Performed the user requirement analysis and process maps analysis based on the various clinical line SOPs and processes – via constant interaction with the business users.
- Developed test metrics and requirement traceability reports, mapping scripts and test conditions, and prepared test closure memos post-system test execution.
- Utilized HP ALM for planning the defect management, test execution and requirements management.
Education
Master of Science - Health Informatics
Sacred Heart University
Fairfield, Connecticut, CT12.2023
Skills
- GxP compliance
- Regulatory requirements
- Validation documentation
- Audit trails
- Data integrity
- Risk assessment
- Electronic signatures
Timeline
Lead CSV Engineer
Gilead Sciences
07.2023 - Current
Sr. CSV Engineer
Cullinan Oncology
10.2022 - 06.2023
Senior Validation Analyst
Johnson and Johnson
01.2019 - 07.2022
Validation Analyst
Sun Pharma
04.2017 - 11.2018
Master of Science - Health Informatics
Sacred Heart University