David Kazemwami

Experience

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  Alcon

  May 2018 - Apr 2020

  • Installed and qualified Lantech Stretch Wrappers. Coordinated installation around production to limit impact. Ensured streamlined and compliant validation strategy based on critical quality attributes to quickly ensure functionality and release to production.• Led Total Preventative Maintenance (TPM) integration on one business unit. Collected, analyzed, and compiled data to identify and select highest ROI lines for implementation. Explored OEE using lean tools to ensure data accuracy and operator engagement.• Led technical support and operator training for Technology Visual system software (Versacall) to ensure full penetration across all shifts and operators with several target lines Show less • Performed Root Cause Analysis to identify opportunities for improvement, problem-solving. Leveraged Six Sigma tools and systems such as Value Stream Mapping and 6S to eliminate waste. • Installed and released Technology Visual System (Versacall) to production lines to enable OEE trends and improvement. Leveraged system to identify and monitor trends to prevent equipment failures from occurring after release.• Implemented the KANBAN system on Production Line to improve material flow and availability.• Analyzed work study data and equipment specifications to establish time and production standards. Show less

  • Validation Engineer

    Jan 2020 - Apr 2020

  • Operation Excellence Associate

    Aug 2018 - Dec 2019

  • Validation Engineer Intern

    May 2018 - Aug 2018
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  Ellab - Validation & Monitoring Solutions

  Oct 2020 - now

  Validation Engineer

  - Collaborated with customers to develop validation documentation, and coordinate project schedules.- Authored, reviewed, approved, and executed validation documents, including Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).- Analyzed and interpreted data from qualification studies to ensure compliance with acceptance criteria, and effectively communicated results to clients.- Provided expert guidance to clients on regulatory expectations, utilizing FDA regulations and industry standards such as ISO, USP, WHO, PDA, ISPE, ASTM, AAMI, and ICH to ensure compliance with regulatory requirements and promote the adoption of best practices.- Qualified and validated equipment, including freezers, refrigerators, incubators, stability chambers, liquid nitrogen tanks, cryo carts, control rate freezers, centrifuges, autoclaves, depyrogenation ovens, and mixers, by measuring critical parameters such as temperature, relative humidity, carbon dioxide, rotation, time, and mass to ensure compliance with regulatory standards and operational reliability.- Conducted seasonal warehouse qualification by performing temperature and humidity mapping during summer and fall, ensuring compliance with regulatory requirements and verifying consistent environmental conditions for product storage.- Executed software qualifications for Valsuite – Validation and Calibration Software, ensuring compliance and functionality.- Installed and calibrated Hanwell Environmental Monitoring Systems to ensure accurate and reliable performance.- Generated expense reports and coordinated travel arrangements, ensuring compliance with company policies and efficient scheduling.- Attended ISPE seminars to expand industry knowledge and stay informed about best practices and emerging trends in the pharmaceutical industry. Show less