Validation Engineer

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.