Cleaning Validation Engineer

3B Staffing LLC

Required Skills:

Hands-on experience performing cleanroom smoke studies (airflow visualization studies).
Experience with cleanroom qualification and requalification.
Knowledge of HEPA-filtered airflow, unidirectional/laminar airflow, and contamination control.
Experience with pharmaceutical, biotech, or medical device manufacturing environments.
Knowledge of GMP compliance and ISO 14644 standards.
Experience with HVAC validation and aseptic processing environments.
Familiarity with IQ/OQ/PQ and validation documentation.

Responsibilities:

Perform smoke studies in cleanrooms, isolators, biosafety cabinets, and manufacturing areas.
Evaluate airflow patterns, turbulence, stagnant zones, and first-air protection of critical product-contact areas.
Conduct and video-record airflow visualization studies for validation and regulatory documentation.
Verify airflow protection during routine operations and operator interventions.
Support cleanroom qualification, HVAC validation, and contamination control activities.
Prepare validation reports and documentation to support regulatory compliance.

Note: Candidates with direct hands-on smoke study experience in pharmaceutical, biotech, or medical device environments are preferred.

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Vacancy posted 1 day ago

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