Validation Specialist

Description

Role: Validation Specialist II

Swiftwater, Pennsylvania, USA

80-90% of shifts are first shift but if they are making a batch, they may need to harvest at midnight instead of 6am. Need to be flexible. 8-4ish are normal hours but they can make adjustments if/when needed.

Day in the life:

• must be self sufficient, they'll need to make their own decisions, will be responsible for process validation, PPQ runs, development runs, upstreem/downstreem processing, cell culture.
• They will not be doing equipment validation.
• This is for process validation - writing, strategy docs, executing protocols, deviations, report writing, proficent tech writing.
• The best fit would be someone with process validation experience, but they have also seen success with candidates who have a mix of process experience and equipment validation experience.

The Position

• This position of Validation Specialist II, in the MSAT function, is to support manufacturing toward industrial excellence to guarantee the accuracy, conformity and competitiveness of the processes and techniques utilized for the production of the vaccines and biologics manufactured at the Client industrial sites.
• The mission of MSAT is to deliver robust and efficient process & testing with associated know-how transfer to Manufacturing & Quality Control (QC).
• MSAT’s function also provides daily support, for manufacturing and QC, toward industrial performance excellence.
• Key contributor for strategy development and execution of develop