Process Engineer I, Data and Knowledge Management

Vaxcyte

. Assess process trends and discrepancies using engineering knowledge and evaluate the technical rationale and potential impact of proposed process improvements .

Posted 10/30/2026full-timeRemote • United StatesSeniorLead💰 $121,000 - $142,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Chemical Engineering and Bioprocess Engineering, with a strong focus on data management, regulatory compliance, and process improvement in biopharmaceutical manufacturing. Proven ability to lead cross-functional teams and drive knowledge sharing initiatives in a highly regulated environment.

Highest-signal resume keywords

Chemical EngineeringBioprocess EngineeringData GovernanceRegulatory ComplianceProcess Improvement

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Process Data AnalysisStatistical MethodsData VisualizationProcess DevelopmentManufacturing Technical Support

Soft Skills

Technical CommunicationProject ManagementCross-Functional Collaboration

Tools & Technologies

SharePointVeeva VaultConfluenceTableauSQL

Industry Keywords

BiopharmaceuticalManufacturing Science and TechnologyClinical TrialsRegulatory SubmissionsGDPRHIPAA21 CFR Part 11ImmunologyVaccinesInfectious Disease R&D

Tech Stack

Tools & technologies

SQLTableauVault

About the role

Key responsibilities & impact

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

What you’ll need

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

Comp & perks

Comprehensive benefits
Equity component