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Fred DiPasquale, Director, Control Systems Engineering & Validation
Fred earned his Bachelors Degree (B.S.) in Chemical Engineering from Drexel University and a M.B.A from St. Joseph’s University in Philadelphia. He has been working in the pharmaceutical field for over 20 years. Fred has worked in all facets of engineering, mostly at primary manufacturing/active pharmaceutical ingredient facilities, including process engineering, project engineering, maintenance and facilities engineering, and process control/instrumentation engineering. Fred started working in automation and automation validation over 13 years ago at bulk vaccine manufacturing and monoclonal antibody (mammalian cell culture) sites. Fred started in traditional DCS configuration, and has been trained in PLC and scalable control system (Delta V) configuration. He has specialized in authorship of functional specifications as well as detailed design specifications, authorship of validation test plans for sequencing and continuous control, coordination of equipment and automation validation on critical equipment, and other design documentation. Fred has performed 21 CFR Part 11 audits, worked on validation of laboratory and IT systems in addition to his traditional manufacturing and control systems, and completed remediation plans for users/clients. He is a member of AIChE, ISPE, and ISA. He has been guest speaker for monthly meetings for the local chapters of ISA and ISPE. Fred has also previously attained Certified Plant Engineer accreditation from the Association of Facilities Engineers. Throughout his career, Fred has supervised large configuration projects that involved multiple contractors, has coordinated compliance audits between corporate and site staffs, and has managed multiple control and validation projects simultaneously. Fred has also been a licensed professional engineer in the Commonwealth of Pennsylvania since 1989 | 