Project Description

Generation of protocols, summary reports, and protocol exceptions

Scheduling and execution of qualification activities

Qualification data collection and analysis against acceptance criteria

Documentation updates (SOPs, Forms, etc.)

Meeting attendance and project coordination

Preferred Experience

7+ years of experience in aseptic fill manufacturing, specifically the commissioning and qualification including performance qualifications of:

Vial Washers

Depyrogenation Tunnels

Isolators

Sterile Fillers

Cappers

Education

Bachelor•s degree in engineering or physical science or related field