Pharmaceutical Investigator - PI24-11597

Job Title: Assistant Deviation Management Specialist
Location: West Point, PA
Duration: 12 Months

Job Summary:

The Assistant Deviation Management Specialist will provide day-to-day technical support to manufacturing operations, focusing on resolving and reducing process deviations. This role involves developing and implementing corrective/preventative actions, leading manufacturing and laboratory investigations, and providing scientific support for manufacturing areas. The specialist will develop working relationships with counterparts in other areas supporting aseptic manufacturing, testing, planning, and release and will utilize scientific and engineering principles to investigate process deviations.

Responsibilities:

• Technical Support: Provide daily technical support to manufacturing operations.
  
• Process Deviations: Resolve and reduce process deviations through development and implementation of corrective/preventative actions.
  
• Investigations: Lead manufacturing and laboratory investigations.
  
• Scientific Support: Offer scientific support for manufacturing areas.
  
• Collaboration: Develop working relationships with counterparts in other areas supporting aseptic manufacturing, testing, planning, and release.
  
• Root Cause Analysis: Conduct troubleshooting and root cause analysis of laboratory test failures and manufacturing atypical events.
  
• Preventative Actions: Develop corrective/preventative actions based on investigations.
  
• Problem Analysis: Analyze complex problems through critical analytical thinking and design/execute laboratory/pilot scale experiments.
  
• Off-Shift Work: Be available for off-shift work as required.

Qualifications:

• Education: B.S./M.S. degree in an appropriate engineering/scientific field.
  
• Experience: 0-3 years post-Bachelor’s degree experience in a cGMP environment (e.g., Production, Development, Process Engineering, Technical Services, or related field) in the pharmaceutical/biotech industry.
  
• Investigation Writing: Previous experience in writing investigations for atypical events in a manufacturing environment.
  
• Methodologies: Familiarity with Lean Six Sigma Methodologies and proven analytical/problem-solving capabilities.
  
• Teamwork: Demonstrated ability to work both independently and as part of a cross-functional team.
  
• Communication: Excellent written and verbal communication skills.