Pharmaceutical Investigator

3 weeks ago

Lansdale, Pennsylvania, United States NavitsPartners Full time
Job Title: Assistant Deviation Management Specialist

Job Summary:

We are seeking a highly skilled Assistant Deviation Management Specialist to join our team at NavitsPartners. As a key member of our manufacturing operations team, you will be responsible for providing technical support, resolving process deviations, and implementing corrective/preventative actions.

Key Responsibilities:

  • Provide daily technical support to manufacturing operations, focusing on resolving and reducing process deviations.
  • Develop and implement corrective/preventative actions to minimize the impact of process deviations.
  • Lead manufacturing and laboratory investigations to identify root causes of process deviations.
  • Offer scientific support for manufacturing areas, including troubleshooting and root cause analysis.
  • Develop working relationships with counterparts in other areas supporting aseptic manufacturing, testing, planning, and release.
  • Conduct troubleshooting and root cause analysis of laboratory test failures and manufacturing atypical events.
  • Develop corrective/preventative actions based on investigations.
  • Analyze complex problems through critical analytical thinking and design/execute laboratory/pilot scale experiments.

Requirements:

  • B.S./M.S. degree in an appropriate engineering/scientific field.
  • 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.
  • Previous experience in 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 both independently and as part of a cross-functional team.
  • Excellent written and verbal communication skills.

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