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Deviation Management Specialist (West Point) - I (Assistant)
Ref No.: 18-25505
Location: West Point, Pennsylvania
•Primary responsibilities include resolution and reduction of process deviations, development and implementation of corrective/preventative actions, and leading manufacturing and laboratory investigations •This individual will be responsible for providing Deviation Management support for bulk vaccine manufacturing areas within Client's Manufacturing Division •This Individual is required to utilize sound scientific and engineering principles to investigate process deviations •Troubleshooting and root cause analysis of laboratory test failures and manufacturing atypical events, development of corrective/preventative actions is required •Analysis of complex problems through critical analytical thinking is required •Off-shift work may be required based on specific assignment.

• B.S./M.S. degree in appropriate engineering/scientific field •Minimum of 2-4 years post-Bachelors degree experience in a cGMP environment (e.g. Production, Development, Process Engineering, Technical Services or related field) in pharmaceutical/ biotech industry •Previous experience in writing investigations for atypical events in a manufacturing environment •Familiar with Lean Six Sigma Methodologies and proven analytical/ problem solving capabilities •Demonstrated ability to work both independently and as a part of a cross-functional team •Excellent written and verbal communication skills