To support a critical assessment initiative, the full-time Texas Licensed Consultant will evaluate aseptic processing, manage product mix-up risks, and assist in creating a CAPA plan onsite in Austin, TX for a duration of 3-4 weeks with the possibility of extension. Key responsibilities Conduct a comprehensive For Cause Gap Assessment across all aseptic processing lines Identify and evaluate potential product mix-up risks and high throughput issues Collaborate to develop a Corrective and Preventive Action (CAPA) plan Required qualifications 7+ years of experience in aseptic processing, specifically with IV bag systems Proven expertise in risk management related to product mix-ups Strong background in high throughput aseptic manufacturing processes Experience in conducting gap assessments and developing CAPA plans Texas Licensed Consultant status required