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

BS in Computer Science, Software Engineering, or a related field, or equivalent professional experience
6+ years’ experience in software industry
Medical device or other regulated industry experience required
3+ years’ experience with automated and technical verification

Staff Validation Engineer

Key skills