Validation Engineer Job at Intellectt INC, Summit, NJ

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  • Intellectt INC
  • Summit, NJ

Job Description

Job Title: CQV Engineer Flow Cytometer

Location: Summit, NJ

Key Responsibilities:

  • Execute Vendor IOQ activities for FACSLyric Flow Cytometers.
  • Support implementation and IOQ of Lighthouse Particle Counters / Non-Viable Particle Counters.
  • Execute qualification protocols and related field activities.
  • Support qualification of approximately 5 Flow Cytometers and 85 Particle Counters.
  • Provide CSV / computerized equipment validation support as required.
  • Prepare and execute qualification documentation in accordance with GMP requirements.

Required Experience:

  • Strong CQV / Equipment Qualification background.
  • Hands-on IQ/OQ or Vendor IOQ execution experience.
  • Experience with Flow Cytometers, preferably BD FACSLyric.
  • Experience with Lighthouse, HIAC, Met One, Climet, Lasair, or similar Particle Counters.
  • Experience qualifying laboratory equipment in pharmaceutical or biotechnology environments.
  • Working knowledge of CSV, GAMP 5, 21 CFR Part 11, and GMP documentation.

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