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.
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.
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.
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.
Peter is a Senior Validation Engineer with more than ten years of experience supporting GMP-regulated pharmaceutical and biotechnology manufacturing operations. He has led and supported commissioning, qualification, and validation (CQV) activities for new facilities, technology transfers, remediation programs, and computerized systems implementations for leading life sciences companies Peter’s expertise spans process equipment, utilities, sterilization systems, and large-scale manufacturing assets, and computerized systems. He is recognized for his collaborative, detail-oriented approach and his ability to develop practical validation strategies that align regulatory requirements with project timelines. Peter holds a B.S. in Biomedical Engineering from California Polytechnic State University, San Luis Obispo.
Matthew is an experienced Commissioning, Qualification, and Validation (CQV) and Computer Software Validation (CSV) professional with over ten years of combined experience supporting GMP manufacturing, laboratory systems, utilities, and quality software platforms. He has led complex validation initiatives including Environmental Monitoring Performance Qualification (EMPQ), equipment remediation to support PPQ readiness, and lifecycle qualification of cleanrooms, utilities, manufacturing equipment, and analytical instruments in compliance with FDA and EMA requirements. Matthew also brings strong CSV expertise, having supported the implementation and validation of Veeva Vault Quality Management Systems through authoring and executing UAT scripts, traceability matrices, and validation summary reports in alignment with 21 CFR Part 11. Earlier in his career, he gained a strong engineering foundation through process engineering roles focused on CAPEX project execution, change management, and startup support. He holds a Bachelor of Science in Chemical Engineering from the University of California, Santa Barbara.
Danny is a seasoned Validation Scientist with deep, hands-on experience across cGMP manufacturing of biologics, small-molecule therapeutics, and personalized medicine diagnostics. He is recognized for his ability to lead and resolve complex, high-risk deviations, often serving as the primary investigator for recurring issues with unknown root causes and cases with potential product-quality or regulatory impact. Danny’s investigations span biochemical process excursions, mechanical and automation-related failures, equipment performance issues, and QC method anomalies, and he delivers root-cause determinations supported by data, interviews, and risk-based analysis. He authors clear, inspection-ready reports and drives cross-functional accountability during issue resolution. In addition to his investigative work, Danny maintains a strong working knowledge of process validation/FMEA/PPQ, cleaning validation, equipment qualification (IOPQ), and lifecycle validation. He holds a Master of Science in Chemistry from the University of California, Santa Cruz.
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.
