Lead Validation Engineer

Job Summary

To support GxP compliance activities across Data Analytics, AI, and Machine Learning, the full-time remote Lead Validation Engineer will provide subject matter expertise, oversee validation processes, and collaborate with various stakeholders to ensure regulatory adherence.

Key responsibilities:

• Provide CSA/CSV expertise for Data Analytics, AI, and Machine Learning platforms
• Develop and review validation deliverables, ensuring compliance with internal procedures and regulations
• Partner with Quality and business stakeholders to maintain ongoing compliance and support system enhancements

Required qualifications:

• 5-8 years of experience with GxP systems and Data Analytics platforms
• Hands-on experience with cloud-based and enterprise data platforms in regulated environments
• Strong understanding of CSA principles, CSV, and SDLC processes
• Experience in authoring and reviewing validation documentation
• Familiarity with GxP regulations and data integrity requirements