Support multiple client expansion projects and execute Commisioning, Qualification, and Decomissioning protocols for utility modification, new and existing equipment for cell culture and purification operations.• Draft, and execute documentation for commissioning and validation deliverables, including URS, DQ, RTM, IQ, OQ, and PQ.• Reviewed P&IDs, process descriptions, execution plans, and vendor documents. • Collaborated with operations teams, including manufacturing and engineering, to execute all CQV protocols.• Conducted temperature mapping studies, mixing studies, temperature adjustments, washroom cleaning cycles, and autoclave cycles. • Supported expansion projects involving utility and equipment modifications of pumps, heat exchangers, mixing tanks, and storage vessels.

Monitor and record critical process parameters.Executed chromatography, viral inactivation, viral filtration, and UFDF operations in a multiprocuts facility.Performed aseptic operations in a cleanroom environment.Perform sampling using aseptic techniques.Train manufacturing personnel in manufacturing operations.Strong operational knowledge of automated washroom equipment, including CIP, COP, glassware washers, and autoclaves.Strictly adhere to SOPs, GMPs, wear appropriate PEE and execute tasks safely and in a timely manner

Supported commissioning, validation, and performance improvement of equipment.Review and Approve MBR in paper and electronic format using MES software.Executed chromatography, viral inactivation, viral filtration, and UFDF operations for commercial and clinical procucts.Monitor and record critical process parameters using DeltaV and OSI Pi trending software.Took on a shift lead role for washroom activities on a rotational basis to meet production demands.Performed aseptic operations in a cleanroom environment.Perform sampling using aseptic techniques.Prepare buffers.Train manufacturing personnel in manufacturing operations.Execute Process Performance Qualification (PPQ) for multiple commercialized products.Strong operational knowledge of automated washroom equipment, including CIP, COP, glassware washers, and autoclaves.Strictly adhere to SOPs, GMPs, wear appropriate PEE and execute tasks safely and in a timely manner.