Process Engineer I, Data and Knowledge Management
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Job Description
Process Engineer managing manufacturing data, governance, and knowledge systems for Vaxcyte’s clinical-stage vaccine development. Supporting regulatory readiness, process insights, and data integrity across biotechnology operations.
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 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
- Develop data management and verification workflows preserving 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
- Develop tools and processes enabling technical teams to access, share, and apply process knowledge
- Champion knowledge sharing across technical, scientific, and operational functions
- Partner with regulatory, quality, R&D, IT, and contract manufacturing teams to develop appropriate solutions
- Ensure compliance with GDPR, HIPAA, and 21 CFR Part 11
- Identify and mitigate risks related to data security, access, and retention
- Report to the Senior Director, Process Validation, Global MSAT
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 Technology (MSAT), process development, manufacturing technical support, or related engineering work, including at least 3 years in the life sciences or biotechnology industry
- Other combinations of education and/or experience may be considered
- 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
- Ability to work effectively with engineering, scientific, and manufacturing teams
- Experience with SharePoint, Veeva Vault, Confluence, Tableau, and SQL is highly desirable
- Experience supporting clinical trials and regulatory submissions (e.g., IND, BLA) is preferred
- Background in immunology, vaccines, or infectious disease R&D is preferred
- Experience scaling systems and processes in a high-growth, early- to mid-stage organization is preferred
Benefits:
- Comprehensive benefits
- Equity component
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