04 May, 2021

Process Engineer

  • Thermo Fisher Scientific
  • Cambridge, MA, USA
Process Engineer Biochemicals / Pharmaceuticals Chemicals

Job Description

At Viral Vector Services (VVS), a division of Thermo Fisher Scientific, we deliver from process development through commercial supply, we offer the expertise and resources necessary to help clients deliver innovative gene therapies. Placed in the forefront of our leading and cutting edge Cell and Gene Therapy business enabling clients to cure genetic, rare, and otherwise untreatable diseases

How will you make an impact?

 

The Process Engineer I is at the front lines of technical support and execution for late stage clinical and commercial gene therapy manufacturing. From new product introduction through process performance qualification, process engineers are responsible for keeping technical deliverables on track and driving process improvements. Success in this role means that patients will receive an entire new generation of lifesaving gene therapy medications.

 

What will you do?
• Provide on-the-floor technical and scientific support for manufacturing operations
• Draft documents with assistance of technical documents, impact assessments, process validation documents, and technology transfer documents, and facility fit assessments
• Provide expertise for process/product impacting investigations
• Oversee data management and analysis
• Support tech transfers and validation readiness
• Own control strategies and other technical documentation including protocols and reports
• Identify and drive continuous improvement projects
• Single-use equipment design and qualification with assistance

 

How will you get here?
• Technical understanding of seed trains, bioreactors, adherent cell culture, transient transfection, harvest, and clarification. In addition single-use system design and qualification.

Education and experience
• B.S. in chemical/biomedical/manufacturing engineering, molecular biology/virology or a related field + 0-1 years experience
• M.S. in chemical/biomedical/manufacturing engineering, molecular biology/virology or a related field
• Experience in manufacturing operations, engineering, MST roles is highly valued.

Knowledge, Skills, Abilities
• Skilled at clear technical communication to diverse internal and external stakeholders.
• Strong project management skills with proven ability to deliver technical projects
• Background in biologics manufacturing including technical topics and working understanding of FDA, EMA and other regulatory bodies.
• Ability to troubleshoot and perform data analysis including statistics and data management
• Team player with proven ability to work collaboratively with multiple stakeholders


Apply Now