Process Engineer I, Data and Knowledge Management

Job not on LinkedIn

🔥 1 minute ago

🇺🇸 United States – Remote

💵 $121k - $142k / year

⏰ Full Time

🟠 Senior

🔴 Lead

👷🏻‍♀️ Engineer

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 Ghost score 1%

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Vaxcyte

WebsiteLinkedInAll Job Openings

201 - 500 employees

Founded 2013

🏥 Healthcare

🏭 Manufacturing

🧬 Biotechnology

Healthcare • Manufacturing • Biotechnology

Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to prevent and treat serious bacterial infections. The company develops broad-spectrum conjugate and novel protein vaccines—using modern synthetic chemistry and a proprietary cell-free protein synthesis platform licensed from Sutro Biopharma—to create difficult-to-make protein antigens more efficiently. Its lead programs are pneumococcal conjugate vaccine candidates VAX-31 (31-valent) and VAX-24 (24-valent) in Phase 2/3 studies, with earlier-stage candidates targeting Group A Strep and Shigella; Vaxcyte focuses on reducing invasive bacterial disease burden, antibiotic resistance consequences, and related morbidity in vulnerable populations.

📋 Description

• 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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