IVAN HERNANDEZ

• Monitored equipment performance and reported deviations to maintain process consistency and product quality.
• Performed line setup, changeovers, and sanitation procedures following SOP and safety requirements.
• Documented manufacturing activities in electronic systems to support traceability and audit readiness.
• Documented all manufacturing activities, maintaining accurate records for reporting purposes and quality assurance audits.
• Prepared materials, components, and supplies to sustain uninterrupted production workflows.
• Performed manufacturing operations in a regulated biopharmaceutical environment while following GMP, SOP, safety, and quality requirements.

Performed wash buffer, preconditioning, recirculation, harvest, and filtration-related operations.

• Operated and supported Filter Press 2, 3, 5, and 6, (Frac II, Frac III, Frac IV-1, and Frac IV-4, FrlI+ III Separation- FP005) extraction/separation

operations.

Executed 5-step manual cleaning and equipment cleaning, including gasket replacement following designated production lots.

• Performed Cleaning In Place (CIP) and Cleaning On Procedures (COP) according to established procedures.

• Worked with V-13 suspension vessel operations, Frac 1 buffer, Liquinox, 500 PPM cleaning processes, LPHS equipment/processes, WFI, and RO systems.

• Used Electronic Batch Management (EBM) to document manufacturing activities and maintain accurate batch records.

• Provided garden upkeep services with clients
• Removing damaged or unwanted plants and weeds to encourage healthy plant growth
• Operate powered equipment such as a lawn mower, leaf blower, and string trimmers.
• Summer of 2022, 2023, and 2024