Fred Ohsiek
Ecolab
Senior Global Technical Manager
Fred Ohsiek is the Sr Global Technical Manager, Life Science (Cleaning Validation) for Ecolab in North America. He earned his bachelor’s in chemistry from University of South Florida.
His professional work experience includes over 23 years of cleaning validation while working for Catalent Pharma Solutions, Amylin Pharmaceuticals, Boehringer Ingelheim, Teva Pharmaceutical Industries, Astellas Pharma Technologies Bayer (biotech division), Novo Nordisk, and Ecolab.
His cleaning validation experience includes risk assessments, cleaning development, validation, and monitoring of cleaning processes for equipment used in small molecule and large molecule product manufacturing; involving drug substance and drug product manufacturing start-up, remediation and legacy justification, creating/improving routine monitoring programs, reducing the CV footprint, and increasing manufacturing capability.
He was one of the authors on the new ISPE Guide: Cleaning Validation Lifecycle – Applications, Methods, and Controls and the cleaning validation acceptance criteria chapter lead.
His professional work experience includes over 23 years of cleaning validation while working for Catalent Pharma Solutions, Amylin Pharmaceuticals, Boehringer Ingelheim, Teva Pharmaceutical Industries, Astellas Pharma Technologies Bayer (biotech division), Novo Nordisk, and Ecolab.
His cleaning validation experience includes risk assessments, cleaning development, validation, and monitoring of cleaning processes for equipment used in small molecule and large molecule product manufacturing; involving drug substance and drug product manufacturing start-up, remediation and legacy justification, creating/improving routine monitoring programs, reducing the CV footprint, and increasing manufacturing capability.
He was one of the authors on the new ISPE Guide: Cleaning Validation Lifecycle – Applications, Methods, and Controls and the cleaning validation acceptance criteria chapter lead.