Must have experience in media fill validation, working in clean rooms and aseptic areas.
Will be overseeing/ monitoring aseptic manufacturing & filling activities.
Should have experience in operating vial washers, tunnels, fillers, isolators, and cappers.
Must have experience in analyzing Media Fill studies to validate the aseptic filling process.
Should be experienced in developing and maintaining Media Fill protocols and procedures in compliance with regulatory guidelines.
Experience in working with environmental monitoring personnel Smoke Studies to Assess Airflow patterns in Cleanrooms and isolators.
Support the validation and qualification of equipment used in filling operations.
Experience in documenting all aspects of the Media Fill study, including procedures, results, and any deviations.
Process development by conducting scale-up and scale-down studies to assess the impact of changes in production scale on filling operations.
Experience in process validation of filling lines.
QA oversight documentation, monitoring shopfloor in production areas, cleanroom areas.

About the Company:
Fusion Life Sciences Technologies LLC

Industry:
Biotechnology/Pharmaceuticals