Senior QA Validation Lead – GMP & IT Systems

FUJIFILM Cellular Dynamics, Inc. in Madison, WI seeks an expert in validation engineering to apply qualification and validation principles to manufacturing processes, quality systems, and regulatory expectations.

The role oversees validation for GMP equipment, facilities, utilities, IT systems, and drug product processes. The candidate will generate IQ/OQ/PQ protocols, SOPs, and validation master plans, lead risk assessments, train end users, and coordinate audits and inspections to ensure data