Carl Wolff
About Carl Wolff
Carl Wolff is a Senior Process Engineer at Barry-Wehmiller Design Group in Boxborough, Massachusetts, with over 20 years of experience in pharmaceutical process design and validation. He specializes in single-use purification processes and has expertise in automation systems and critical systems evaluation for biotechnology operations.
Work at Barry-Wehmiller Design Group
Carl Wolff has been serving as a Senior Process Engineer at Barry-Wehmiller Design Group since 2021. He operates from Boxborough, Massachusetts, where he applies his extensive knowledge in pharmaceutical process design and validation. His role involves working on single-use purification processes, which include depth and viral filtration, tangential flow filtration (TFF), chromatography, and viral inactivation. Wolff's contributions are critical in supporting biotechnology operations through the development of building automation systems and black and clean utilities.
Education and Expertise
Carl Wolff earned his Bachelor of Science degree from the State University of New York at Buffalo, where he studied from 1981 to 1986. His educational background laid the foundation for his expertise in various engineering disciplines. Wolff specializes in critical systems evaluation, which assists pharmaceutical and biotechnology companies in achieving their quality and engineering objectives. His knowledge encompasses all phases of the design process, including P&ID and PFD development, as well as user requirements specification.
Background
With over 20 years of experience in pharmaceutical process design and validation, Carl Wolff has developed a comprehensive skill set in the industry. His background includes significant involvement in the development and execution of qualification protocols, such as Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and Process Validation (PV). Wolff has also worked on automation systems scripting, covering I/O, PID loop testing, and ISA/S88 operations simulation.
Achievements
Throughout his career, Carl Wolff has designed and commissioned various systems essential for pharmaceutical operations, including pharma gas systems, cryogenic systems, and Water for Injection (WFI) generation and distribution. He has also contributed to bulk fill and packaging automation projects, implementing vision systems for barcode and character recognition. His extensive experience in buffer and media transfer, fermentation, and purification processes further underscores his capabilities in the field.