Hiring: Staff Engineer, Process Development and Manufacturing Company: Vaxcyte Location: San Carlos, CA Job Posted Time: 2026-09-11 10:36:35 Employment Type: Contract About the job Required Skills: •Lead downstream purification technology transfer and scale-up activities from Process Development to GMP manufacturing facilities for clinical and commercial programs. •Provide technical support for GMP manufacturing campaigns, process validation (PPQ), continued process verification (CPV), and lifecycle process management. •Serve as a subject matter expert and technical leader in downstream purification operations, including chromatography, filtration, UF/DF, scale-up, and process characterization. •Design, execute, and analyze small-scale and pilot-scale studies supporting process characterization, comparability assessments, validation strategies, troubleshooting investigations, and process lifecycle management. •Support process monitoring, statistical data analysis, predictive modeling, trend analysis, troubleshooting, and root cause investigations to improve process robustness and performance. •Partner with CMOs and cross-functional teams to support successful process transfer, manufacturing readiness, compliance, and operational execution. •Drive continuous improvement and risk mitigation initiatives and apply scientific and engineering principles to solve complex process and manufacturing challenges and develop innovative technical solutions. •Author and review technical documentation, regulatory support documents, deviations / investigations, and technical assessments. Qualifications: •Extensive experience in downstream purification process development, process characterization, technology transfer, scale-up, and GMP manufacturing support. •Strong expertise in chromatography, filtration, UF/DF, and downstream processes. •Demonstrated experience applying statistical analysis, multivariate data analysis, and predictive modeling techniques to support data-driven decision-making tools for process characterization, technology transfer, process validation, continued process verification (CPV), and manufacturing process monitoring. •Applied hands-on capability in laboratory-scale and pilot-scale purification operations. •Strong knowledge of cGMP regulations and manufacturing quality/compliance systems. •Excellent communication, technical writing, cross-functional leadership, project management, and presentation skills. •Demonstrated ability to influence matrix teams without direct authority. •Prior experience with vaccine or conjugate manufacturing processes preferred. Compensation: •$186,000 - $218,000 / year •Competitive benefits and rewards package •The compensation package will be competitive and includes comprehensive benefits and an equity component Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!