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
Profile
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