Staff Engineer, Process Systems

🔥 2 hours ago

🏄 California – Remote

🏄 California – Remote

💵 $157k - $183k / year

⏰ Full Time

🔴 Lead

⚙️ Systems Engineer

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Vaxcyte

WebsiteLinkedInAll Job Openings

201 - 500 employees

Founded 2013

🏥 Healthcare

🏭 Manufacturing

🧬 Biotechnology

Healthcare • Manufacturing • Biotechnology

Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to prevent and treat serious bacterial infections. The company develops broad-spectrum conjugate and novel protein vaccines—using modern synthetic chemistry and a proprietary cell-free protein synthesis platform licensed from Sutro Biopharma—to create difficult-to-make protein antigens more efficiently. Its lead programs are pneumococcal conjugate vaccine candidates VAX-31 (31-valent) and VAX-24 (24-valent) in Phase 2/3 studies, with earlier-stage candidates targeting Group A Strep and Shigella; Vaxcyte focuses on reducing invasive bacterial disease burden, antibiotic resistance consequences, and related morbidity in vulnerable populations.

📋 Description

• Lead and manage all engineering activities for advanced biotechnological systems, including utilities, process equipment, automation systems, and facilities. • Work on significant and unique issues where analysis of situations or data requires an evaluation of intangible variables and may impact future concepts, products or technologies. • Review and approve process equipment documentation, such as protocols, test plans, reports, and other deliverables, ensuring alignment with company standards and regulatory requirements. • Conduct comprehensive risk assessments and design strategies to validate and optimize critical process parameters in compliance with industry standards and regulatory guidelines. • Lead complex system and equipment inspections, including FATs (Factory Acceptance Tests), SATs (Site Acceptance Tests), and IQ/OQ/PQ (Installation Qualification/Operational Qualification/Performance Qualification), ensuring precision and compliance. • Lead engineering feasibility studies, conceptual & basic design activities for projects across a range of products and sites. • Direct and manage validation initiatives, ensuring compliance with cGMP, FDA, EMA, and other applicable regulatory agencies. • Oversee the review and approval of validation protocols, plans, and reports, ensuring their alignment with industry standards and ensuring robust and reliable processes. • Analyze complex validation data to identify critical trends, continuously improving the reliability, efficiency, and compliance of validated systems. • Create formal networks with key decision makers and serve as an external spokesperson for the organization with CDMO and supplier partners. • Oversees the activities of a project and teams involved in cross-functional engineering projects from conception through completion, balancing complex timelines, budget constraints, resource allocation, and quality standards. • Collaborate effectively with senior project managers, cross-functional teams, contractors, and external vendors to coordinate, prioritize, and execute engineering activities. • Provide strategic technical leadership and foster a culture of innovation, collaboration, and continuous improvement. • Ensure project deliverables are met within scope and timeline while maintaining focus on compliance, quality, and cost-effectiveness.

🎯 Requirements

• 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.

🏖️ Benefits

• The compensation package will be competitive and includes comprehensive benefits and an equity component.