USP Process Transfer Engineer

First, did you know that AKKA Belgium is going to be AKKODIS soon? Because of the merger with MODIS.

AKKODIS is a global leader in the engineering and R&D market that is leveraging the power of connected data to accelerate innovation and digital transformation.

As part of the development of the activities at one of our clients, we are looking for a USP Process Transfer Engineer.

 
What are your responsibilities?

As an Upstream Process Transfer Engineer, you will contribute to upstream process tech transfer activities of late-stage and/or commercial biologics to enable launch of these molecules into both internal and external commercial scale facilities. Your key responsibilities are:

• Supporting Tech Transfer of USP Processes from Development to Internal Manufacturing and CMOs, and between commercial-scale facilities
• Supporting the commercial-scale Process Validations for the Upstream Process in Drug Substance manufacturing
• Providing routine (on-the-floor) support during manufacturing campaigns
• Providing deviation and investigation support
• Supporting Continuous Process Verification (CPV) activities
• Supporting Regulatory inspections and filings
• Acting as a Subject Matter Expert of late-stage and commercial biologics Upstream manufacturing processes

In other words, the USP Process Transfer Engineer will:

• Support USP tech transfer and PPQ activities
• Author technical protocols/reports and ensure a high scientific and quality standard
• Perform routine (on-the-floor) support during manufacturing campaigns
• Provide deviation and investigation support to Manufacturing
• Support CPV activities, as required

7EBECB5E8C1243CAB36B6C8607B5BF77@ts.com