11 Apr, 2022
Thermo Fisher Scientific
Cambridge, MA, USA
At Viral Vector Services (VVS), a division of Thermo Fisher Scientific, we deliver from process development through commercial supply, and we offer the expertise and resources necessary to help clients deliver innovative gene therapies.
The Process Validation Engineer III is a leader of technical support and execution of process validation and continuous process verification (CPV) projects. The PV Engineer develops process performance qualification (PPQ) and supporting validation protocols and studies. In addition, the PV Engineer owns development of CPV protocols and administration of the process monitoring plan.
- Provide on-the-floor technical and scientific support for critical manufacturing operations.
- Designs and executes validation plans and studies.
- Expertise and ownership of complex process/product impacting investigations.
- Oversee strategy for data management and analysis.
- Technical lead for validation readiness.
- Own control strategies and other technical documentation including protocols and reports.
- Identify and drive large and complex continuous improvement projects.
- Develop and administer CPV protocols and process monitoring strategies.
B.S. in chemical/biomedical/manufacturing engineering, molecular biology/virology or a related field + 5 years experience preferred.
M.S. in chemical/biomedical/manufacturing engineering, molecular biology/virology or a related field + 2 years experience
PhD in chemical/biomedical/manufacturing engineering, molecular biology/virology or a related field + 1 year experience
- Expert in clear technical communication to diverse internal and external stakeholders.
- Experience in PPQ and/or CPV.
- Highly developed project management skills including proven ability to deliver large technical projects on aggressive timelines.
- Expert in biologics manufacturing or virology including technical topics in upstream and downstream.
- Direct experience in FDA, EMA oversight including quality records and audits.
- Proven ability to troubleshoot complex technical issues and perform advanced data analysis in a cross-functional team.
- Team player with proven ability to build consensus and drive performance with diverse stakeholders.