• Develop, execute, and maintain validation deliverables, including validation plans, specifications, protocols, summary reports, and SOPs. • Conduct Computer System Validation (CSV) activities in compliance with FDA 21 CFR Part 11, and ISO guidelines. • Perform / Support risk assessments, gap analyses, and remediation for validation projects. • Collaborate with cross-functional teams to support change management processes and assess the impact on validated systems. • Participate in internal and external audits and regulatory inspections, addressing validation-related queries. • Support lifecycle management of validated systems, including implementation, maintenance, and decommissioning. • Contribute to the development and improvement of validation policies and procedures. • Ensure the validation team is well-trained and equipped to support GxP Operations. • Design and implement test cases for functional and automated testing, ensuring comprehensive coverage of requirements. • Stay current with evolving regulatory expectations (CSA, GxP, SaMD) and technological advancements in validation and testing.