Gene Therapy Bioprocess Engineer

작업 내용

Gene Therapy Bioprocess Engineer

Walloon Brabant

Your Responsibilities?

• Process transfer from development to DP-DS clinical/commercial manufacturing.
• Act as Gene Therapy Bioprocess Engineering SME for facility and equipment design and qualification.
• Integrate gene therapy bio-process engineering team to the site.
• Design and qualify single-use systems such as liquid transfer assemblies, manifolds and bags.
• Design and qualify DP/DS process equipment. Generation of risk assessments and user specifications for manufacturing systems and single-use materials.
• Lead transfer of new processes and technologies to-and from clinical manufacturing while ensuring operational excellence and cGMP compliance.
• Closely collaborate with process development and (clinical) manufacturing to ensure seamless technology transfers.
• Roll out of raw materials and single-use equipment: risk assessments, specification setting and design of single use assemblies.
• Generation of relevant documentation such as Process Descriptions, SOPs and risk assessments to implement new processes to clinical manufacturing.
• Design/generation of DP/DS manufacturing recipes in distributed control system.
• Floor support.
• Trending and analysis of manufacturing data and generation of campaign reports.
• Support establishment of appropriate data management systems for knowledge management.
• Support of regulatory filings and application of Quality-by Design (QbD) principles.
• Lead continuous digitalization of the clinical manufacturing plant.
• Drive continuous process optimization, implementation of new technologies and operational improvements in close collaboration with process development.
• Support root-cause investigations, change controls, CAPA plan implementations in close collaboration with the QA department.

Your profile?

• Master’s Degree preferably in Bioengineering or related fields.
• At least 3 years of industrial experience, preferably in a GMP environment (chemical, pharmaceutical or biotech).
• Expert knowledge of Biologics Manufacturing, specifically of Drug Product/Drug Substance Manufacturing. rAAV Manufacturing and/or Process Development experience would be highly beneficial.
• Excellent Process Engineering skills including scale-up and knowledge of tech transfer principles.
• Experience in sterility concepts using Single Use System (SUS), bioburden reduction approaches, including systematic troubleshooting.
• Hands-on experience with mammalian cell culture- and/or purification systems.
• Experience with distributed control system (e.g. PCS7, Delta V,…)
• Very good command in English, a good command in French is a strong asset.

Our offer?

Jefferson Wells offers you a permanent contract as consultant with an attractive salary package and will give you access to trainings in technical matters and soft skills. We will be your career partner for each step along the way.

Do you want to apply or want to know more ? Please send your CV or contact me : marie.defruit@jeffersonwells.be