Deep working knowledge of aseptic processing, sterility assurance, contamination-control strategy, cleanroom operations, first-air principles, RABS/isolators, airflow visualization, environmental monitoring, media fills, cleaning/disinfection, and microbiological risk. This consultant will focus on the broader non-intervention remediation portfolio, including technical assessments, scientific justification, validation and qualification strategy, cleaning and contamination-control remediation, implementation support, CAPA documentation, and evidence required for effective closure.