• Oversee day-to-day validation activities of the Enterprise Systems • 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