Specialist
Current- Worked on the start-up of a new $150MM Sterile Processing facility starting post-qualification which included two significant sterility investigations
- Lead portion of sterility investigation that led to finding root cause of sterility failure that stopped processing for ~1 year
- Became Subject Matter Expert (SME) for the Charging and Sterile Filtration portions of the process
- Served as a shift lead for Engineering batch production and Bulk Sterile challenge activities
- Initiated
- Acted as an SME for a wholesale sterility assurance review of process following second Sterile Challenge failure