LL01-251114 - CQV Specialist Smoke Testing / Airflow Visualization

Validation & Engineering Group-posted about 1 month ago
Full-time • Mid Level
Juncos, PR
101-250 employees
Personal and Laundry Services
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The CQV Specialist for Smoke Testing is responsible for developing, executing, and documenting airflow visualization studies in support of cleanroom and equipment qualification. This role verifies unidirectional airflow, identifies turbulence zones, and ensures compliance with Annex 1 airflow requirements for sterile manufacturing.

  • Plan and execute smoke studies (airflow visualization) for cleanrooms, RABS, isolators, filling lines, and critical Grade A/B environments.
  • Set up and qualify smoke/fog generation equipment, lighting, and video recording systems.
  • Document airflow patterns to identify turbulence, dead spots, reverse flows, and compliance gaps.
  • Support qualification activities including FAT/SAT, IQ/OQ, and room qualification for HVAC systems.
  • Write protocols (airflow visualization plans, IQ/OQ protocols) and prepare final reports with photographic/video evidence.
  • Interface with Engineering, Facilities, QA, and Aseptic Operations to resolve airflow issues.
  • Lead deviations, risk assessments, and CAPAs related to airflow or equipment performance.
  • Ensure compliance with ISO 14644-1/2, EU Annex 1 airflow requirements, and ASTM E2500.
  • Support regulatory inspection readiness and provide airflow-related technical responses.
  • Bachelors in Mechanical Engineering, Industrial Engineering, Life Sciences, or related field.
  • 5+ years of experience in CQV, HVAC qualification, or aseptic facility commissioning.
  • Strong understanding of airflow dynamics, HEPA performance, differential pressure control, and cleanroom classification.
  • Experience with IQ/OQ execution for cleanroom equipment, isolators, and RABS.
  • Ability to interpret airflow patterns and provide engineering recommendations.
  • Experience with particle counters, differential pressure monitoring, BMS/EMS systems.
  • Experience qualifying sterile filling lines or aseptic equipment.
  • Knowledge of HVAC balancing, cleanroom design, and environmental controls.
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