Willis is a leader in Computer Systems Validation CSV) and Computer Software Assurance (CSA) with extensive experience in project management and a proven record of delivering compliant, efficient, and scalable computerized system implementations across multiple facility start-ups. He has served in key cross-functional roles - including System Owner, Business Process Owner, Validation Lead, and Quality Assurance Lead- for computerized systems, providing comprehensive end-to-end oversight across all phases of the system lifecycle. From initial assessments and vendor selection through validation, operation, and retirement, Willis employs risk-based methodologies to ensure adherence to global regulatory requirements, including 21 CFR Part 11 and EU GMP Annex 11, throughout the software development lifecycle (SDLC). He holds a Bachelor of Science in Biochemistry and Molecular Biology from the University of California, Davis.
Jennifer is a Validation Engineer with hands-on experience in equipment, cleaning, and process validation within regulated biopharmaceutical manufacturing environments. She has supported full lifecycle validation activities—spanning periodic reviews, revalidation, performance qualification, and gap assessments—for critical systems including autoclaves, washers, bioreactors, temperature control units, and cleaning processes. Jennifer brings a strong foundation in technical problem-solving and cross-functional collaboration, having worked closely with Quality, Manufacturing, and Subject Matter Experts to manage deviations, perform troubleshooting, and drive continuous improvement initiatives. Her background also includes applied engineering design experience—leveraging simulation, testing, and validation methodologies to translate complex requirements into reliable, manufacturable systems. She holds a Bachelor of Science in Biomedical Engineering from the University of California, Davis.
Saad is an Operations Manager taking ownership of oversight and technical lead aspects for Equipment, Computer System, Facilities and Utilities CQV projects. He specializes in serving as technical lead in areas of Validation, Engineering, Manufacturing and Quality Assurance. He is known for his strategic project management and hands-on approach in overcoming obstacles. He has a knack for blending technical excellence with practical implementation to accomplish both compliance and efficiency. He has successfully led numerous high impact / visibility projects across several client sites in the life sciences industry. He pairs this with a passion for talent acquisition and development with a committment in fostering a culture of continuous improvement and growth. Saad received his Bachelor of Science in Chemical Engineering from UC Davis.
Ahmad Rabi is a Quality Assurance and Validation leader with over 20 years of experience supporting GMP-regulated biopharmaceutical and gene therapy operations. He specializes in validation lifecycle management, cleaning validation, complex deviation investigations, CAPA effectiveness, and data integrity compliance in alignment with 21 CFR Part 11 and global regulatory standards. Ahmad is known for his practical, risk-based approach to quality and his ability to bridge technical, operational, and compliance perspectives to achieve sustainable solutions. He has successfully supported numerous facility startups and system qualifications through close collaboration with engineering, manufacturing, and QA teams. He is rooted in building efficient, compliant processes that help clients maintain inspection readiness and product integrity. He holds a Bachelor of Science in Microbiology from the University of California, Davis.
Danny is a Validation Scientist with extensive experience in cGMP manufacturing of biologics, small molecules, and personalized medicine diagnostics. He serves as a lead investigator for complex and potentially product-impacting deviations, with investigations spanning biochemical, mechanical, and QC method-related issues. Danny has specialized expertise in identifying and preventing recurring deviations that affect product quality and regulatory compliance. He holds a Master of Science in Chemistry from the University of California, Santa Cruz.
Jeffrey is a Process Validation and Technology Transfer Technical Leader with over 15 years experience in various Manufacturing Science & Technology (MSAT), Chemistry, Manufacturing, and Controls (CMC), Quality Assurance (QA), and Clinical Manufacturing / Manufacturing Support roles. He specializes in manufacturing technology transfer and process validation of multi-modal biological drug substances and drug products in both early-stage and late-stage chemistry, manufacturing, and controls (CMC) development, but also uses his broad Technical Operations knowledge base to support a variety of functions such as Quality Oversight for CQV. He has successfully managed multiple high-profile New Product Introduction projects, including implementation of several early-stage and late-stage clinical manufacturing processes that have successfully progressed through CMC stage gates into commercially approved products. Jeffrey received his Bachelor of Science in Biomedical Engineering from UC Davis.
Kurt is a Technical Leader with over 20 years experience in Manufacturing Science & Technology and Process Technology & Engineering roles. He has held positions of increasing leadership at BioMarin Pharmaceutical including Director of Novato Site MSAT and TT Lead for clinical production in a new AAV gene therapy product facility. He has a proven track record of enabling new technologies and addressing growth areas, such as facility expansions and accompanying technology transfer activities. He is adept at managing and driving efforts involving process monitoring, process/capacity modeling, data management solutions, conceptual facility design, process optimization and scale-up, and new technology implementation. Kurt received his Bachelor of Science in Chemical Engineering from University of Washington and Ph.D. in Chemical Engineering from Massachusetts Institute of Technology.
