Position: Assistant Deviation Management Specialist Location: West Point, PA (Onsite) Duration: 12 Months
Responsibilities:
Primary responsibilities include day-to-day technical support to manufacturing operations, including 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 scientific support for manufacturing areas within Client's Manufacturing Division
This Individual will also develop working relationships with counterparts in other areas supporting aseptic manufacturing, testing, planning, and release and 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 and the design/execution of laboratory/pilot scale experiments is required
Off-shift work may be required
Required:
BA/BS required
Qualification:
S./M.S. degree in appropriate engineering/scientific field
Minimum of 0-3 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
