Peter Walters is a lead process engineer at CRB, specializing in biological process and facility design. He oversees conceptual and detailed design, multi-discipline coordination, and generation of design deliverables including conceptual floorplans and facility arrangement drawings, design narratives, P&IDs, material and energy balances, process simulations, cost analysis and specialized reports.
Over the last 15 years working in pharmaceutical process and equipment design, he has gained a unique purview into aseptic equipment design, process scale up, pilot and manufacturing operations. His expertise includes experimental design, process characterization, equipment and process troubleshooting, and manufacturing for clinical Phase 1 through commercial production. He is well versed in cGMP manufacturing, including generation of procedures and batch records, validation of systems and processes, production performance and process and product analysis. He has designed process facilities for monoclonal antibodies, gene therapies, cell therapies, aseptic novel processes, both in stainless steel and single-use. He helped author an NDA, has participated in FDA facility inspections, and is a patent awarded co-inventor of a novel process formulation method. Peter was recognized by Consulting – Specifying Engineer with the 40 Under 40 award in 2018. He is an industry contributor, and has previously spoken at ISPE, INTERPHEX, BPI West conferences as well as various online webinars.
Peter graduated from University of California, Davis with a degree in chemical / biochemical engineering. He is a Southern California native and enjoys playing soccer and spending time with his family.