Process Engineer I, Data and Knowledge Management at Vaxcyte in San Carlos, CA

Job description

Join our Mission to Protect Humankind! Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, which have serious and costly health consequences when left unchecked. Working to eradicate or treat bacterial infections such as invasive pneumococcal disease, Group A Strep, and Shigella is just the beginning. Our path to success is clear and well-defined, and Vaxcyte is set up to go the distance. WHAT we do is every bit as important as HOW we do it! Our work together is guided by four enduring core values: *RETHINK CONVENTION: We bring creative and intellectual diversity to every facet of the work we do in order to innovate and re-innovate the way vaccines are delivered. *AIM HIGH: We embody our collectively audacious goal to courageously make the most complex biologics ever attempted to protect humankind. *LEAD WITH HEART: Everyone leads at Vaxcyte with a kindness-first, inclusive approach to collaboration and vigorous debate that advances our business objectives. *MODEL EXCELLENCE: The magnitude of our challenge requires our shared commitment to demonstrating integrity, accountability, equality and clarity across communications and decision making. Summary: As we grow, we are seeking a strategic and collaborative Process Engineer I, Data and Knowledge Management to ensure the integrity, accessibility, and effective use of data and knowledge assets across the organization. This role will execute component-level analysis, utilizing data and knowledge resources critical to our process development, regulatory, and operational activities. The Process Engineer I, Data and Knowledge Management is instrumental in ensuring scientific data integrity, regulatory readiness, and the preservation of institutional knowledge in a dynamic, fast-paced clinical environment. Essential Functions: Engineering Analytics & Process Insights: Assess process trends and discrepancies using engineering knowledge, and evaluate the technical rationale and potential impact of proposed process improvements Apply chemical and biochemical engineering principles to evaluate relationships between process parameters, unit operation performance, and product quality attributes Partner with data science team to drive data visualization, reporting, and insights. Support the use of AI/ML and automation for improved data analysis and knowledge extraction. Manufacturing Process Data Management & Governance: Acquire, integrate, and technically evaluate manufacturing process data from internal teams and contract manufacturing sites to support process monitoring, continuous improvement, and CMC regulatory submissions. Develop data management and verification workflows that preserve the accuracy, integrity, and traceability of manufacturing process data. Lead and own data verification for all commercial regulatory submissions. Process Knowledge Management: Develop structured systems and workflows to capture and retain organizational knowledge, including protocols, study results, lessons learned, and decision rationales. Develop tools and processes that enable technical teams to access, share, and apply process knowledge to support manufacturing and process improvement. Champion a knowledge-sharing culture across technical, scientific and operational functions. Collaboration & Technical Leadership: Partner with regulatory, quality, R&D, IT and contract manufacturing teams to understand technical needs and develop appropriate solutions. Compliance & Risk Management: Ensure compliance with data protection and clinical trial regulations, including GDPR, HIPAA, and 21 CFR Part 11. Identify and mitigate risks related to data security, access, and retention. Requirements: Bachelor’s degree in Chemical Engineering, Bioprocess Engineering, or a related engineering discipline is required. 8+ years of relevant experience in biopharmaceutical process engineering, Manufacturing Science and T