Michael Choi

Background

About Michael Choi

With 13 years of experience in the Bio-Pharma industry, I am a dedicated Quality Engineer deeply committed to ensuring the production of safe and effective drugs. My expertise encompasses critical aspects of pharmaceutical manufacturing, with a specialization in processes crucial to the quality and integrity of drug production. Key Areas of Expertise: 1. Sterilization: SME in moist-heat sterilization using Sterilize in Place (SIP) systems and Moist-Heat Autoclaves, ensuring the highest safety standards in drug manufacturing. Cleaning Validation: Experienced in cleaning verification and validation of essential equipment, such as Bioreactors, Fermenters, chromatography systems, utilizing CIP. Extensive experience in cleaning verification and validation of COP items using Glassware washers. Temperature Control Units: Expert in temperature mapping of critical areas, including storage rooms, incubators, refrigerators, and freezers, ensuring optimal conditions for drug storage. Risk Analysis Expert: Well-versed in conducting FMEA (Failure Mode and Effects Analysis) analysis for facilities and processes and SRA (System Risk Assessments) for equipment and systems, ensuring proactive identification and mitigation of potential risks. Investigation and Resolution of Deviations and Non-conformances: Experienced in leading deviation investigations and implementing Corrective and Preventive Actions (CAPA) to address challenges and ensure continuous improvement in manufacturing processes. Professional Journey: Currently serving as a Validation Specialist at AbbVie, I play a pivotal role in supporting the manufacture of drug substances at the Bioscience Laboratories Irvine facility. In my previous role as the Senior Manager/Project Manager at Samsung Biologics, I successfully led a team to procure, install, and qualify 10 autoclaves and 16 Glassware Washer & Dryers for the new P4 manufacturing facility, honing my leadership and project management skills. Continuous Learning and Development: I have completed validation training through organizations such as the Parental Drug Association (PDA) and the International Society of Pharmaceutical Engineers (ISPE). I pursued an Executive MBA from the Quantic School of Business and Technology to enhance my skills in making informed CAPEX decisions and overseeing projects efficiently. In summary: My journey as a Quality Engineer is characterized by the pursuit of excellence and a commitment to safety. I look forward to contributing to the advancement of drug manufacturing and drug safety.