Kishorkumar Kotini

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August Bioservices
Validation Engineer
Kishorkumar Kotini is Senior Validation Engineer, MSAT, at August Bioservices, a US-based CRO/CDMO, offering a full range of drug discovery, drug development, and drug manufacturing capabilities from preclinical to commercialization. He has more than 12 years of experience in the pharmaceutical sterile and non-sterile industry. Kishor has expertise in designing validation strategies/commissioning and qualification of process equipment and utilities/streamlining process and procedure. He has sound knowledge of modern quality tools such as statistical process control, process capability, FMEA, and CAPA tools. Kishor has a MSc in microbiology and is a Certified Lean Six Sigma Green Belt.

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Heightened awareness, due to the pandemic, of the need for domestic manufacturing capacity has rejuvenated the biopharmaceutical manufacturing industry and resulted in new commissioning projects. However, cross-country/continental travel restrictions and social distancing–based work protocols during the first two years of the pandemic necessitated adopting unique commissioning approaches....