Mina Farag
Validation Engineer @Nivagen Pharmaceuticals, Inc.
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WORK HISTORY
Validation Engineer @Nivagen Pharmaceuticals, Inc.
Qualification of Equipment and Systems:• Perform or oversee the Installation Qualification (IQ), Operational Qualification (OQ), andPerformance Qualification (PQ) of new and existing equipment and systems.• Qualification of equipment in sterile manufacturing facility (e.g, aseptic processing, sterile filling, isolators, autoclave sterilization).• Ensure compliance with regulatory requirements for equipment qualification and validation.• Knowledge of validation equipment like Kaye validator, temperature and RH data loggers etc.Validation Documentation and Protocols:Prepare and review validation reports to ensure they meet regulatory and company requirements.• Maintain traceability of validation activities and ensure all validation records are accurately documented, maintained, and stored.Process Validation and Cleaning Validation:Conduct and manage process validation studies to confirm the sterility and quality of pharmaceutical products.• Work with cross-functional teams (e.g. production, quality control, engineering) to optimize manufacturing processes and ensure consistency and repeatability.• Support the development and implementation of new processes, ensuring that they are validated per regulatory requirements.
EDUCATION
Egyptian aviation academy
69 %, Mechanical Engineering
ABOUT MINA FARAG
Experienced Validation Engineer with a demonstrated history of working in the pharmaceuticals and Biotechnology industry. Skilled in:1-Auto CAD, Microsoft Word 2-Completing Validation Documentation Package includes- 2.1 Write validation documents (URS, IOQ, PQ, RQ) in compliant with cGMP regulations. 2.2 Project scope includes HVAC, Compressed Air, PW, WFI, Clean Steam, Process Gases, BSC, Incubators, Storage Freezers, Refrigerators and Cold Rooms. 2.3 Experience/Familiarity with Engineering drawings (P & ID, Electrical, Mechanical) 2.4 Conduct risk assessment for equipments. 2.5 perform and document work following Good Engineering Practices (GEPs) and Good Documentation Practices (GDPs). 2.6 perform Commissioning and Qualification (C&Q) activities for utilities and process equipment and systems. 2.7 Develop validation plans for Operations and QC ensuring system qualifications align with company policies and regulatory requirements. 2.8 Execute the performance qualification projects for clean utilities (PW, WFI, Clean Steam, Process Gases and Compressed Air).3-Communication, Interpersonal Skills, and Organizational Structure. Strong operations professional.
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