Lab Instrument Qualification Engineer

3 weeks ago


Wilmington, United States Katalyst Healthcares and Life Sciences Full time
Responsibilities:
  • Systems Upgrades
  • Contractor Tasks and Responsibilities:
  • Lab equipment is currently running on Windows 7 which is no longer supported. Consultant will be responsible for the qualification activities for the lab instruments for the new operating system and the new software upgrade.
  • Skill, Experience Level, & "other" Background Requirements:
  • Lab Instruments being qualified are.
  • FTIR's
  • Particle counters and DNA sequencers
  • Develop and manage GxP system lifecycle documentation, including Validation Plans, User Requirements Specifications, Configuration Specifications, Testing Protocols (IQ/OQ/PQ), User Acceptance testing, Traceability Matrix, System, Validation Reports, SOPs, Change Control Documentation, and Risk assessment reports.
  • Interface with internal stakeholders to lead project deliverables to completion.
  • Conduct system compliance risk assessment as needed.
  • Perform Data Integrity assessments, as needed.
  • Ensure the data flow for each instrument family meets regulatory requirements
Requirements:
  • Bachelor's degree in scientific or engineering discipline
  • 5+ years' experience in Good Manufacturing Practice (GMP) / QA within FDA regulated environments.
  • Experience in Instrument qualification/validation is a must.
  • Experience with major change controls like upgrading operating systems is a Plus.
  • Experience with some or all of the following instruments in the past - DNA Sequencers, Particle Counters, etc.
  • Experience in developing full validation documentation and testing protocols (IQ/OQ/PQ/UAT) within the various SDLC phases.
  • Excellent Technical Writing and Communication skills


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