Process Engineer I, Data and Knowledge Management

This is a fully remote position, open to applicants in United States.

📋 Description

• Evaluate process trends and discrepancies utilizing engineering expertise, while assessing the technical rationale and potential effects of suggested process enhancements.

• Utilize chemical and biochemical engineering principles to analyze the relationships between process parameters, operational performance, and product quality characteristics.

• Collaborate with the data science team to enhance data visualization, reporting, and insights.

• Support AI/ML initiatives and automation to improve data analysis and knowledge extraction.

• Acquire, integrate, and conduct technical evaluations of manufacturing process data from internal teams and contract manufacturing sites.

• Create data management and verification workflows to ensure the accuracy, integrity, and traceability of manufacturing process data.

• Take the lead on data verification for all commercial regulatory submissions.

• Develop structured systems and workflows to capture and maintain organizational knowledge.

• Create tools and processes that enable technical teams to access, share, and utilize process knowledge.

• Advocate for knowledge sharing across technical, scientific, and operational teams.

• Collaborate with regulatory, quality, R&D, IT, and contract manufacturing teams to devise suitable solutions.

• Ensure adherence to GDPR, HIPAA, and 21 CFR Part 11.

• Identify and mitigate risks associated with data security, access, and retention.

• Report directly to the Senior Director, Process Validation, Global MSAT.

⛳️ Requirements

• A Bachelor’s degree in Chemical Engineering, Bioprocess Engineering, or a related engineering field is mandatory.

• At least 8 years of relevant experience in biopharmaceutical process engineering, Manufacturing Science and Technology (MSAT), process development, manufacturing technical support, or related engineering roles, with a minimum of 3 years in the life sciences or biotechnology sector.

• Alternative combinations of education and/or experience may be evaluated.

• Proficiency in interpreting manufacturing process data and utilizing engineering and statistical methodologies to assess process performance.

• Demonstrated experience in leading enterprise data governance and knowledge sharing projects in a highly regulated setting.

• Excellent technical communication, project management, and cross-functional collaboration abilities.

• Capability to work efficiently with engineering, scientific, and manufacturing teams.

• Familiarity with SharePoint, Veeva Vault, Confluence, Tableau, and SQL is highly preferred.

• Experience in supporting clinical trials and regulatory submissions (e.g., IND, BLA) is advantageous.

• A background in immunology, vaccines, or infectious disease R&D is desirable.

• Experience in scaling systems and processes within a rapidly growing, early- to mid-stage organization is preferred.

🏝️ Benefits

• Comprehensive benefits package.

• Equity component.