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 vital to help clients deliver innovative gene therapies. Placed in the forefront of our leading and innovative Cell and Gene Therapy business enabling clients to cure genetic, rare, and otherwise untreatable diseases.

How will you make an impact!

The Process Engineer II will provide technical support for late stage clinical and commercial operations at the CDMO facility in Cambridge, MA. From new product introduction through process performance qualification, process engineers complete technical transfers, process validations and implement process improvements. Additional responsibility includes supporting the lifecycle of existing manufacturing equipment such as chromatography/TFF skids, Isolators and Fillers. The Downstream engineer will be a member of an organization of process, automation, and facilities engineers collaborating with internal groups such as Manufacturing and Quality as well as external vendors and customers.

What will you do!

• Generate and complete process/equipment studies
• Support and/or lead process-related investigations
• Maintain manufacturing process data and perform analysis/trending
• Drive expertise in tech transfer, validation, and equipment maintenance
• Identify and drive continuous improvement projects
• Support Downstream and Fill/Finish operations
• Ensure operational capabilities meet regulatory requirements for commercial operations
• Learn critical skills to be successful in the life science industry

How will you get here

Provide process and equipment expertise in a fast-paced and highly technical environment at a groundbreaking gene therapy CDMO site. Work with a diverse and inclusive team to deliver projects that meet customer expectations while defining standards and driving improvements.

Education

Bachelors Degree (required) in Chemical/Biomedical/Manufacturing Engineering or a related field.

Experience

• Minimum 2-3 years of experience in engineering/manufacturing environment
• Experience in Downstream and/or Fill/Finish biologics manufacturing
• Experience with cGMP equipment including chromatography, filtration, isolator and/or filling machinery

Knowledge, Skills, Abilities

• Strong interpersonal and communication; written and oral
• Project management skills with ability to deliver project timelines
• Basic understanding of regulatory requirements and guidelines
• Ability to solve technical and equipment issues
• Knowledge of equipment testing protocols and requirements
• Perform data analysis and trending
• Ability to work independently