Deviation Management Specialist - I

Job Title: Deviation Management Specialist - I
Job Location: West Point, PA
Job Duration: 12 Months (possibility of extension)

Primary Responsibilities:

• Day-to-day technical support to manufacturing operations, including resolution and reduction of process deviations.
• Development and implementation of corrective/preventative actions.
• Leading manufacturing and laboratory investigations.
• Providing scientific support for manufacturing areas within client.
• Developing working relationships with counterparts in other areas supporting aseptic manufacturing, testing, planning, and release.
• Utilizing 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.
• Analysis of complex problems through critical analytical thinking and the design/execution of laboratory/pilot scale experiments.
• Off-shift work may be required.

Education:

• B.S./M.S. degree in appropriate engineering/scientific field.

Experience Required:

• Minimum of 4-8 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.

Skills and Abilities:

• Demonstrated ability to work both independently and as a part of a cross-functional team.
• Excellent written and verbal communication skills.