Vaxcyte - Staff Engineer, Process Systems

• Bachelor’s or Master’s degree in Engineering (Chemical, Mechanical, Biomedical, or related field) or Biotechnology with a minimum of 10+ years of experience in Bioprocessing/Process Engineering within the biotechnology, pharmaceutical, or biopharmaceutical industry. Other combinations of education and/or experience may be considered. • Proven leadership experience in managing teams and large-scale Capex projects, including utilities, process equipment, and automation systems. • Extensive knowledge of biopharmaceutical manufacturing processes and equipment, particularly DCS, ISA-88 batch process control, and PLC-based control systems. • Demonstrated success in managing engineering activities for large-scale or complex facilities under tight timelines and budget constraints. • Expertise in drug product manufacturing and associated unit operations including compounding, automated visual inspection, assembly, labelling & packaging. • Expert-level knowledge of cGMP, FDA, EMA, ICH guidelines, and other global regulatory requirements. • Strong understanding of bioprocessing, including upstream and downstream processing, aseptic processing, and sterilization techniques. • Advanced proficiency in statistical analysis, risk assessment methodologies, and process validation best practices. • In-depth experience with quality management systems (QMS) and electronic documentation systems to maintain compliant documentation and support audit activities. • Capability to support and, when required, perform a range of broader engineering functions and activities, including project management, process optimization, automation, and utilities engineering. • Exceptional leadership, communication, and interpersonal skills, with the ability to influence at all levels of the organization and external partners. • Strong problem-solving, analytical thinking, and decision-making capabilities, especially in high-pressure environments. • Ability to prioritize and manage multiple complex projects, balancing conflicting demands while ensuring regulatory compliance and business goals. • Excellent mentoring and coaching abilities, fostering a culture of innovation and continuous improvement. • Reports to: Sr. Director, Engineering & Facilities • Reports to: • Location: North Carolina • Location: • Work Arrangement (may be adjusted based on business needs, job responsibilities, or changes to company policy): Remote