Senior validation Engineer
Pharma International Company
Total years of experience :10 years, 6 Months
Develop and generates URS/IQ/OQ/PQ qualification
documents for manufacturing equipment & instruments.
Perform qualification studies (IQ, OQ &PQ) for production equipment & lab. Instruments and prepare the required protocols, SOP’s, Forms & reports.
Perform HVAC qualification and environmental monitoring like HEPA filters testing, area Classification, air volume, differential pressure, temperature &RH%.
Perform utilities qualification which include water system, compressed air, and pure steam.
Perform Sterile Area Qualifications and environmental monitoring inside area.
Perform process validation (concurrent and prospective). Perform cleaning validation for all production equipment.
Participate in training of new employees.
Participate in Factory acceptance tests "FAT", for multi - types of pharmaceuticals Equipment & lines
in (Italy & Germany….etc.)
GMP Skills.
Perform computer system validation (Baan system, MS, PLC and any computer system related to Pharmaceutical industry.
Develop and generates URS/IQ/OQ/PQ qualification documents facility and building support systems (HVAC, water systems).
Supervise FAT & SAT for machines and/or line.
Assist in the creation of change controls and evaluate needed validation tasks.
Perform different environmental monitoring testing (particle count, differential pressure, air changes) and related statistical analysis and generate final reports.
Collect & analyze validation data.
Bachelor's Degree in Chemical Engineering