Jose A. Lopez Rivera

Manufacturing professional with 3 years of experience supporting sterile pharmaceutical manufacturing in a GMP-regulated environment at Amgen. Experienced in aseptic processing, component preparation, sterilization operations, filter integrity testing, cleanroom practices, and electronic manufacturing documentation (EBR/LIMS). Master of Science in Molecular Biotechnology with a strong foundation in biotechnology, quality systems, and regulatory compliance.

Manufacturer – Component Preparation (AML14) - Amgen - Puerto Rico

• Supported sterile pharmaceutical manufacturing by executing component preparation activities in compliance with GMP, SOP, and cleanroom requirements.
• Performed pre- and post-use filter integrity testing to verify equipment readiness and manufacturing compliance.
• Assembled, disassembled, cleaned, sterilized, and prepared manufacturing equipment for production operations.
• Operated autoclaves, ultrasonic cleaning systems, and part washers supporting sterile manufacturing processes.
• Applied aseptic techniques while maintaining contamination control and product quality standards.
• Completed accurate manufacturing documentation using Electronic Batch Records (EBR) and LIMS.
• Collaborated with cross-functional teams to support manufacturing readiness and production schedules.

Master of Science - Molecular Biotechnology - Interamerican University of Puerto Rico (2026-06)

Bachelor of Science - General Biology - University of Puerto Rico at Humacao