Validation Engineering Manager

Position SummaryWe are seeking a Validation Engineering Manager to lead a team of validation engineers supporting manufacturing processes, equipment, and systems in a regulated CBR environment — including blood bank, gene therapy, biologics, and vaccine operations. This individual will set validation strategy, ensure compliance with FDA and cGMP standards, and partner cross-functionally with Quality, Manufacturing, and R&D. Key ResponsibilitiesManage, mentor, and develop a team of validation engineersSet team priorities, allocate resources, and ensure projects are completed on scheduleDefine and drive validation strategy for processes, equipment, utilities, and systemsOversee authoring and execution of validation documentation (URS, IQ, OQ, PQ, Validation Summary Reports)Maintain the Master Validation Plan and lead change control activitiesReview and approve validation protocols and reports; present findings to leadershipEnsure compliance with FDA regulations and cGMP; lead regulatory inspections and auditsQualificationsBachelor's degree in Engineering or related technical field10+ years of validation experience in a regulated industry; 3+ years in a management or team lead roleDirect experience in one or more CBR disciplines: blood bank, gene therapy, biologics, or vaccineStrong experience with process validation and equipment qualificationKnowledge of FDA regulations and cGMPPreferredExperience across multiple CBR disciplinesSterilization validationMicrobiological / microvalidation experience