David Raab

Genesis AEC
Senior Process Engineer
David Raab has more than 20 years of professional experience leading all aspects of manufacturing process design from early stages of concept development through commissioning. David’s broad perspective on engineering design has been developed over his career through experiences ranging from production engineering at manufacturing facilities, capital project development supporting multiple businesses, and most recently as an engineering process design consultant at Genesis. He also brings insight from supporting multiple industries. Although his current focus is primarily in supporting life sciences clients, he has also worked with manufacturers of personal care products and specialty chemicals. David has had a lead process engineering role on diverse teams to support projects in the US, Europe, Asia, and South America. David’s specialties include risk assessments and hazard evaluations. He is a trained and experienced facilitator in process hazard analysis, including layer of protection analysis. In his current role at Genesis, David serves as the process team leader for an advisory group on facility design for hazardous materials. He is also a leader in facilitation of contamination control strategy assessments and has presented on this topic at the 2023 ISPE annual meeting.

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Data Analysis of Contamination Control Strategies for Production

On 25 August 2023, the long-awaited revision to Annex 1 became effective, introducing significant regulatory changes, including the requirement of a documented contamination control strategy (CCS). During a workshop at the 2023 ISPE Annual Meeting & Expo, 11 teams of attendees were presented with a risk-based methodology to develop and evaluate CCS elements focused on extrinsic...