CSV Validation & Testing Lead – Life Sciences

Roles & Responsibilities:

• Validation & Testing
• Design, develop, and execute validation strategies, test plans, and test cases
• Perform functional, integration, and data validation testing for enterprise systems
• Validate Tableau reporting outputs and eArchive system integrations
• Verify metadata accuracy and completeness during QMS migration activities
• Ensure archival integrity, traceability, and compliance of migrated records
• Compliance & Data Integrity
• Support CSV (Computer System Validation) activities and documentation
• Ensure compliance with ALCOA+ data integrity principles and regulatory standards
• Assist in validation lifecycle activities including execution evidence and defect tracking
• Collaborate with QA and compliance teams to address validation findings and remediation activities
  Coordination & Reporting
• Work closely with business, QA, and technical teams during testing and validation cycles
• Prepare validation summaries, execution reports, and compliance documentation
• Support issue resolution, retesting, and final sign-off activities
• Validation strategy and test plans
• Test execution and defect reports
• Data and metadata validation reports
• Archival verification documentation
• Final validation summary reports

Education & Experience:

• 10+ years of experience in validation and testing within Life Sciences or regulated environments
• Strong experience in Clinical Data Validation and QMS validation processes
• Experience supporting CSV activities and regulatory compliance initiatives
• Knowledge of ALCOA+ principles, data integrity standards, and validation methodologies
• Hands-on experience validating Tableau reports and archival/eArchive systems
• Strong analytical, documentation, and stakeholder communication skills
• Experience with QMS migration and metadata validation
• Familiarity with Life Sciences compliance standards and GxP environments
• Exposure to enterprise archival systems and regulatory audit support