Our client is hiring a Senior Aseptic Processing & Contamination Control Consultant to provide technical leadership for a 16 week full-time project. In this role you will perform a thorough review and risk assessment of the aseptic fill-finish process, and detailed documentation of the entire process from setup to final product. You will identify all high-risk aseptic interventions, identification of contamination mechanisms, and develop appropriate risk reduction strategies in support of CAPA-102537, CAPA-102539, and ICP-100445.

Experience:

• 15+ years sterile manufacturing experience
• Deep aseptic processing expertise
• First air specialist
• Contamination control expert
• Strong documentation skills
• Training and Workshop facilitation

The company provides sterile injectables and offers clinical and commercial non-viral aseptic fill/finish services for vials and pre-filled syringes on four fill lines, in addition to lyophilization, terminal sterilization, analytical, stability, packaging and serialization, and additional support services.