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Vaxcyte is a clinical-stage vaccine innovation company developing high-fidelity vaccines to protect against bacterial diseases including invasive pneumococcal disease, Group A Strep, and Shigella. As the company progresses toward late-stage development and commercialization, it is implementing dedicated biologics manufacturing facilities.
The Staff Engineer, Process Systems will serve as a technical leader and process system owner, responsible for all engineering activities related to commercial launch and routine GMP manufacturing. This role ensures efficient and compliant production of Vaxcyte's products across advanced biotechnological systems, including utilities, process equipment, automation systems, and facilities.
Key responsibilities include:
**Process System Ownership:** Lead and manage engineering activities for biotechnological systems; review and approve process equipment documentation (protocols, test plans, reports); conduct comprehensive risk assessments and design validation strategies for critical process parameters; lead complex system inspections including FATs, SATs, and IQ/OQ/PQ activities; direct engineering feasibility studies and conceptual design activities across products and sites.
**Validation:** Direct and manage validation initiatives ensuring compliance with cGMP, FDA, EMA, and other regulatory requirements; oversee review and approval of validation protocols, plans, and reports; analyze complex validation data to identify trends and drive continuous improvement.
**Project Management & Cross-functional Leadership:** Create networks with key decision makers and serve as external spokesperson with CDMO and supplier partners; oversee cross-functional engineering projects from conception through completion, balancing timelines, budgets, resources, and quality standards; collaborate with senior project managers, teams, contractors, and external vendors; provide strategic technical leadership fostering innovation and collaboration.
The role reports to the Director of Engineering & Facilities and requires close collaboration with Process Development, MSAT, Supply Chain, Quality, Project Management, Business Development, Regulatory functions, and CDMOs. This is a senior technical position for someone with deep expertise in biologics manufacturing process systems and regulatory compliance.
