Summary:As we grow, we are 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. This role will execute component-level analysis, utilizing data and knowledge resources critical to our process development, regulatory, and operational activities. The Process Engineer I, Data and Knowledge Management is instrumental in ensuring scientific data integrity, regulatory readiness, and the preservation of institutional knowledge in a dynamic, fast-paced clinical environment.
Essential Functions:Engineering Analytics & Process Insights:- 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 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.
Manufacturing Process Data Management & Governance:- 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.
Process Knowledge Management:- 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.
Collaboration & Technical Leadership:- Partner with regulatory, quality, R&D, IT and contract manufacturing teams to understand technical needs and develop appropriate solutions.
Compliance & Risk Management:- 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.
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, with the ability to work effectively with engineering, scientific, and manufacturing teams.
- Experience with tools like SharePoint, Veeva Vault, Confluence, Tableau, and SQL is highly desirable.
Preferred:- Experience supporting clinical trials and regulatory submissions (e.g., IND, BLA).
- Background in immunology, vaccines, or infectious disease R&D.
- Experience in scaling systems and processes in a high-growth, early- to mid-stage.
Reports to: Senior Director, Process Validation, Global MSAT
Location: United States
Work Arrangement (may be adjusted based on business needs, job responsibilities, or changes to company policy): Remote
Compensation:The compensation package will be competitive and includes comprehensive benefits and an equity component.
Salary Range: $121,000 - $142,000
Relocation: This role is not eligible for relocation assistance.
