Deviation Management Specialist

3 days ago


West Point, United States Collabera Full time
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Deviation Management Specialist

Contract: West Point, Pennsylvania, US

Salary: $41.00 Per Hour

Job Code: 354265

End Date: 2024-10-25
Days Left: 29 days, 3 hours left

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About the Role:
  • We are seeking a highly motivated individual to join our team as a
  • Technical Support Engineer in the pharmaceutical/biotech industry.
  • The ideal candidate will have a degree in an engineering or scientific field and some experience in a cGMP environment.
  • This role will involve providing technical support to manufacturing operations, investigating process deviations, and developing corrective/preventative actions.

Responsibilities:
  • Provide day-to-day technical support to manufacturing operations -
  • Resolve and reduce process deviations
  • Develop and implement corrective/preventative actions
  • Lead manufacturing and laboratory investigations
  • Develop working relationships with counterparts in other areas supporting aseptic manufacturing, testing, planning, and release
  • Utilize scientific and engineering principles to investigate process deviations
  • Troubleshoot and conduct root cause analysis of laboratory test failures and manufacturing atypical events
  • Develop corrective/preventative actions
  • Analyze complex problems through critical analytical thinking
  • Design and execute laboratory/pilot scale experiments
  • May require off-shift work
  • Clean room gowning to support deviation investigation and shopfloor support

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

Required Skills:
  • 0-3 years post-Bachelors degree experience in a cGMP environment
  • Previous experience in writing investigations for atypical events in a manufacturing environment
  • Familiar with Lean Six Sigma Methodologies
  • Proven analytical and problem-solving capabilities
  • Ability to work independently and as part of a cross-functional team Excellent written and verbal communication skills

Job Requirement
  • Deviation Management
  • CAPA
  • root cause analysis
  • scientific
  • cGMP
  • deviation
  • investigation
  • lab
  • biotech
  • pharmaceutical
Reach Out to a Recruiter
  • Recruiter
  • Email
  • Phone
  • Rohan Lazarus
  • rohan.lazarus@collabera.com

Apply Now

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