Generating and executing commissioning and qualification protocols for various equipment including the following: Controlled Temperature Units (CTUs): LN2 Freezers, Controlled Rate Freezers, -80°C Freezers, -20°C Freezers, 2-8°C Refrigerators, Incubators, Incubator/Shakers, Walk-In Cold Room/Freezer, and Depyrogenation Oven.Bioreactors: Wave ReadyToProcess WAVE 25 with CBCU, and Sartorius Bioreactor, 15L up to 2000L. Analytical equipment: Cell Viability Analyzer (ViCell) and Cedex Bio Analyzer. Wrote Protocol Summary Reports and Protocol Deviations.Cleaning Validation of purification equipment.Participated in Environmental monitoring studies to conform to the new ISO 14001:2015 standardEnsuring compliance with Quality Management System: ISO 9001, 21 CFR, and ICH Q10Validation SME for several CAPA investigations.

Generating and executing commissioning and qualification protocols for various lab equipment including the following: Controlled Temperature Units (CTUs): LN2 Freezers, -80°C Freezers, -20°C Freezers, 2-8°C Refrigerators, Incubators, and Incubator/Shakers.Bioreactors/Fermentors: Wave Bioreactor and POD 20-50 EH, WAVE ReadyToProcess WAVE 25 with CBCU, and New Brunswick Scientific 300L Fermentor. Revised/Updated Environmental Monitoring documentation to replace older FS-209 Standard Class 100 to Class 100K to newer ISO 14001 StandardSteam Sterilization SME for Bioreactor biocontamination CAPA investigation.Wrote Protocol Summary Reports and Protocol Deviations.

Generated IOQ Protocols for various lab equipment including the following: Wave Bioreactor and POD System, New Brunswick Scientific I-26 Incubator Shakers, and Bellco Model BG-927 Roller Bottle Incubator.

Executed Sanitization Commissioning and IOQ on Purification Vessels from 4,000L on up to 7,000L

Developed Verification, Initial and Continuing Cleaning Validation protocols for various types of equipment (both upstream and downstream) for Merck – including the following: Various Fermentors, P-18 CARR Centrifuge (PowerFuge), 16 inch CUNO filter cartridges and housing, 40 inch Polysep II filter cartridges and housing, and Millipore Pellicon Filtration Skid.Executed Verification, Initial and Continuing Cleaning Validation protocols on various types of equipment by taking Rinse, Swab, and Bioburden samples. Scheduled Validation activities with the Merck Operations and QC labs.

Downstream: Have extensive experience in Cleaning Validation: Including CEHT (Clean Equipment Hold Time), CIP, COP, DEHT (Dirty Equipment Hold Time), Depy ovens, and GMP washers.Have performed cycle development and optimization on: GMP UF & Tank Cleaning Skid and GMP washer (Hamo). Have extensive experience in Equipment Validation: Including QA air samplers (airIDEALS), CIP skid, COP skid, decontaminating and sterilizing autoclaves. Worked on Stability Validation for Buffers: Using pH, conductivity, UV spec. and endotoxin testing.Air handler system, door interlock system, and WFI system validation.Wrote Cleaning Validation Master Plan, IQ/OQ/PQ Protocols, Protocol Summary Reports, and Protocol Deviations. Validation SME for particles in final product CAPA investigation.Upstream:Have varied experience in Cleaning Validation: Including CEHT, CIP skid, DEHT, and SIP on the 150L and 1500L BioreactorsHave extensive experience in Equipment Validation: Including 150L and 1500L Bioreactors sterility broth validation. Steam Sterilization SME for Bioreactor transfer line biocontamination CAPA investigation.

Purification (Downstream): Have varied experience in protein and polysaccharides purification using columns and TFFs.Have performed cycle development: GMP TFF Cleaning Skid.Have extensive experience in leading protein and polysaccharide purification activities in GMP facilities. Instrumental in scale-up of several proteins from research through to clinical manufacturing then to Phase III manufacturing.Wrote GMP batch records and SOPs and instrumental in the Validation of major pieces of equipment.Lead CAPA investigation involving excessive product loss in purification step.Wrote Batch Record Deviations as needed.Fermentation (Upstream):Have extensive GMP bacterial fermentation experience working with 20L, 150L and 1500L Bioreactors. Worked on developing optimization processes to increase yield, decrease bio-burden and maximize harvest recovery strategies. Instrumental in developing scale-up parameters of several bacterial strains from process development to clinical manufacturing then to Phase III manufacturing. Fermentation duties include: generating bacterial cell bank under strict aseptic conditions, and growing bacterial cultures. Operating instruments such as, Cell bomb, Gaulin homogenizer, Carr continuous centrifuge for cell lysis and Inclusion Body processing. Lead CAPA investigation involving media formulation and lack of growth in bioreactor.Wrote Batch Record Deviations as needed.