Mr. Carriker has over 6 years of experience working in GMP industries as a Process Validation Engineer with an additional 2 years of experience as a Chief of Technical Operations & Head Scientist. Providing engineering and validation services for new and existing GMP facilities, equipment, materials and systems, Shawn has worked in the biotech and pharmaceutical space for 5 years, attaining a strong understanding of single use processing and qualification. Shawn has developed and deployed extractables and leachables risk management systems with a focus on data-based justification for patient safety and product quality and has worked with clients to defend the approach to regulatory officials. Shawn has a strong proficiency qualifying single use systems for cell expansion, cell culture, filtration, chromatography and UF/DF unit operations as well as media and buffer formulation systems and connections between the equipment regarding functionality and SISPQ+ of contacting API. Shawn has designed and executed studies providing data for qualification of single use materials and has experience sizing and performing design review of process utility systems. Shawn has on-site equipment start-up and commissioning experience for GMP commercial operations. Shawn also has a proficiency in interpreting and analyzing qualification data and has generated PFDs and DCFDs for various GMP processes. Mr. Carriker also brings exceptional organizational skills and an ability to scope projects from broad vision to action item level, prioritizing dynamically based on changing organizational needs.