Ahmed Kasem

Experience

1. Process Engineer

   Formulated Solutions

   Dec 2024 — Present · Largo, FL, US

   Support design transfer and scale-up for blending, filling, packaging, labeling, and serialization from lab-scale batches to commercial production, identifying and optimizing Critical Process Parameters (CPPs) to ensure efficiency and repeatability. Draft and maintain GMP batch records, Bills of Materials, product specifications, and validation protocols (IQ/OQ/PQ), ensuring FDA and quality system compliance. Lead process validation activities, including pilot batches and commercial-scale runs, to ensure robust, compliant production processes. Communicate directly with customers to understand their product requirements and provide tailored engineering and process solutions, ensuring alignment with technical, quality, and production goals. Create and execute engineering studies, protocols, and reports to support process development, equipment implementation, and qualification activities. Design and implement process improvements and equipment upgrades for complex formulations, from pilot through to commercial scale. Conduct root cause analyses and lead FMEA efforts to identify and mitigate risks, driving continuous improvement initiatives. Provide engineering support and training to manufacturing teams, optimizing process efficiency.

Education

• Broward College

  Associate's degree, Biomedical/Medical Engineering

  2018 — 2020

• Florida International University

  Bachelor of Science in Biomedical Engineering, Biomedical/Medical Engineering