Process Engineer I, Data and Knowledge Management

Vaxcyte•San Carlos, CA

5d•$121,000 - $142,000•Remote

About The Position

Vaxcyte is 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. The role performs component-level analysis and uses data and knowledge resources that support process development, regulatory, and operational activities. It contributes to scientific data integrity, regulatory readiness, and the preservation of institutional knowledge in a clinical-stage, fast-paced environment. The position assesses process trends and discrepancies, applies chemical and biochemical engineering principles to evaluate process parameters, unit-operation performance, and product quality attributes, and partners with data science to develop visualizations, reporting, and insights. It supports AI/ML and automation for data analysis and knowledge extraction. The role acquires, integrates, and evaluates manufacturing process data from internal teams and contract manufacturing sites; develops workflows that preserve data accuracy, integrity, and traceability; and leads data verification for commercial regulatory submissions. It also develops systems and tools for capturing, retaining, accessing, and sharing organizational process knowledge, and champions knowledge sharing across technical, scientific, and operational functions. The Process Engineer collaborates with regulatory, quality, R&D, IT, and contract manufacturing teams, while ensuring compliance with data protection and clinical trial regulations, including GDPR, HIPAA, and 21 CFR Part 11. The position is remote in the United States and reports to the Senior Director, Process Validation, Global MSAT. The salary range is $121,000–$142,000. The role is not eligible for relocation assistance.

Requirements

Bachelor’s degree in Chemical Engineering, Bioprocess Engineering, or a related engineering discipline is required; other combinations of education and/or experience may be considered.
8+ years of relevant experience in biopharmaceutical process engineering, Manufacturing Science and Technology (MSAT), process development, manufacturing technical support, or related engineering work, including at least 3 years in the life sciences or biotechnology industry.
Experience interpreting manufacturing process data and applying engineering and statistical methods to evaluate process performance.
Proven experience leading enterprise data governance and knowledge-sharing initiatives in a highly regulated environment.
Strong technical communication, project management, and cross-functional collaboration skills, with the ability to work effectively with engineering, scientific, and manufacturing teams.

Nice To Haves

Experience with tools such as SharePoint, Veeva Vault, Confluence, Tableau, and SQL.
Experience supporting clinical trials and regulatory submissions, such as IND or BLA.
Background in immunology, vaccines, or infectious disease R&D.
Experience scaling systems and processes in a high-growth, early- to mid-stage environment.

Responsibilities

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 the 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.
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.
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.
Partner with regulatory, quality, R&D, IT, and contract manufacturing teams to understand technical needs and develop appropriate solutions.
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.