Client is looking for 2 Investigators with a strong background working on fill finish lines with Isolator fill line technology. Filling inspection and packaging but the majority will be with filling. Responsible for the deviations working on the line. The line itself is automated but has manual paper procedures. Know how fill finish lines work, pre and post test, and sterility assurance. Isolator, empty vial inspections prior to fill, washing vials that go through the tunnel into the isolator, sealing the vials with a rotary capper. Experience with a capping machine, ideally with OPTIMA equipment experience. Gowing will be roughly 20% of the time, as needed, when you will have to observe the procedures. Will be grade C but will change to grade A if in the Isolator.
Must have a strong background with aseptic fill finish and isolator lines, writing deviation investigations involving aseptic techniques. Strong technical writing (ability to provide example if requested) and problem solving skills. Background with root cause analysis (prefer 5-Whys, Fishbone Ishikawa and/or Human Error Root Cause Analysis) is required. Background with Veeva QMS and/or OPTIMA is preferred. BS in life sciences required.
- Fill Finish, Isolator, Investigations, Deviations, Root Cause
IL: Investigation Owner 2 Spots (234119)