AI Software Validation Consultant

We are seeking an experienced AI Software Validation Engineer to support the qualification and validation of AI/ML-enabled laboratory software within a regulated pharmaceutical/GxP environment. The role will focus on the validation of AI-based automated microbiological plate counters, including IQ/OQ/PQ, AI model training and qualification, comparative performance testing, edge-case testing, data integrity assessment, and ongoing model retraining/requalification.

This is an opportunity to establish and implement an AI software validation framework from first principles, leveraging existing computer system validation (CSV) methodologies while addressing the unique risks associated with AI/ML systems. The successful candidate will work closely with Engineering, Quality, Microbiology, CSV, and CQV teams and will contribute to a broader FDA Warning Letter remediation program.