Day-to-Day Responsibilities
Design and review aseptic process steps such as compounding, filling, sterile filtration and stoppering.
Set up and qualify cleanroom equipment, including isolators, filling lines and laminar airflow units.
Prepare and review process validation protocols and reports, including media fill runs.
Monitor environmental and personnel monitoring data and investigate any contamination alert.
Work with the quality team on deviations, change controls and root cause analysis.
Train operators on gowning, aseptic technique and line procedures.
Support scale-up and technology transfer from development to commercial sterile batches.


