The Senior Validation Specialist is responsible for performing initial and routine validation activities for GxP computerized systems, including qualification of laboratory instruments, system setup, troubleshooting, and technical documentation.
Required competencies include knowledge of validation concepts, cGMP, industry regulations, strong communication, critical reasoning, and ability to work independently or in teams.
Key duties involve developing validation protocols, executing validation and qualification activities, analyzing data, preparing reports, supporting lifecycle documents, and collaborating with various departments and external vendors.
Qualifications include a Bachelor's degree in Science or Engineering (preferred) and 8+ years of relevant experience.
Working conditions may require gowning in classified environments. The role emphasizes project management, documentation, audit defense, and adherence to regulatory and quality standards.