Deviation Management Specialist - I (Assistant)
 Spectraforce Technologies | |
 United States, Pennsylvania, West Point | |
 Apr 30, 2025 | |
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Title: Deviation Management Specialist - I (Assistant) Duration: 12 Months Location: West Point, PA 19486 Qualifications: * B.S./M.S. degree in appropriate engineering/scientific field but would consider AA or no Degree with good experience *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 *Excellent written and verbal communication skills 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 *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 | |