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

What skills do you bring to the table?

• Master’s degree in Life Sciences, or has equivalent experience, in a relevant scientific discipline.
• Experience in the biopharmaceutical industry is a must
• Understanding of Upstream bioprocessing principles (cell culture processes, media preparation, centrifugation/filtration methods, …)
• Good understanding of biopharma operations (e.g. process development, pilot scale) and cGMP
• Ability to communicate effectively and connect with peers from different functions (matrix organization) to ensure projects are delivered
• Good analytical thinking and problem-solving mindset
• Familiar with various statistical and data trending techniques
• Good technical writing skills
• Ability to manage multiple tasks and meet deadlines with a high tolerance for ambiguity
• Self-motivated, innovation mindset, can-do attitude, team player
• Good knowledge of English, both oral and written; knowledge of French is a must.

What’s the offer you can’t refuse?

As an Akkodis Team Member, you will be:

• Onboarded in your position via a buddy process
• Supported in your career by your Business Manager
• Actor of your training plan and your personal and professional development
• Benefiting from a permanent contract
• Benefiting from a competitive salary package including several extra-legal benefits

Do you any questions? You can contact me at marie.defruit@akkodis.com