Deviation Management Specialist - I

Job Title: Deviation Management Specialist - I
Job Location: West Point, PA 19486
Job Duration: 12+ Months Contract (Possibilities of Extension)
 
Pay Rate: $41.75/hr. on W2
 
Responsibilities:

• Provide day-to-day technical support to manufacturing operations.
• Resolve and reduce process deviations through corrective and preventative actions.
• Lead manufacturing and laboratory investigations.
• Provide scientific support for manufacturing areas within Client’s Manufacturing Division (MMD).
• Develop working relationships with counterparts in aseptic manufacturing, testing, planning, and release.
• Utilize sound scientific and engineering principles to investigate process deviations.
• Perform troubleshooting and root cause analysis of laboratory test failures and manufacturing atypical events.
• Develop and implement corrective and preventative actions.
• Analyze complex problems through critical analytical thinking and laboratory/pilot-scale experiments.
• Work off-shift as required.

• B.S./M.S. degree in an appropriate engineering or scientific field.
• Minimum of 4–8 years of post-Bachelor’s degree experience in a cGMP environment (e.g., Production, Development, Process Engineering, Technical Services, or related field) within the pharmaceutical/biotech industry.
• Previous experience writing investigations for atypical events in a manufacturing environment.
• Familiarity with Lean Six Sigma methodologies and proven analytical/problem-solving capabilities.
• Demonstrated ability to work independently and as part of a cross-functional team.
• Excellent written and verbal communication skills.