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.