(Senior) Engineer/Scientist Manufacturing Sciences & Technology (CSC)
Locations: Beerse, Belgium
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Requisition ID: 1905762165W
The Manufacturing Scientist/Engineer is responsible for successful introduction and follow-up of clinical manufacturing activities in the Drug Product (DP)-Pilot Plant (PP), being the PP-representative in the drug product development teams. The scientist/engineer supports process development, plant introduction, scale-up & tech-transfer of DP processes from DPDS to JSC from a (clinical) manufacturing perspective.
* Representative from the Clinical supply chain (CSC) organisation in the Drug Product Development project team, ensuring E2E risk management in support of robust process development and successful clinical manufacturing.
* Accountable for successful introduction of clinical manufacturing activities in the Pilot Plant, acting as a receiving partner for the DP development team
* Follow up on the progress of the project together with the Drug Product Development organisation to assure timely readiness of installation at receiving site.
* Start from the detailed knowledge of the equipment and the processes during development to deliver DPDS design inputs for the receiving commercial site (URS and process requirements)
* Establish manufacturing Sciences expertise for different equipment platforms, in a cross-functional collaboration with DPD and PAT-experts. This includes the development and implementation of new technologies/processes/PAT applications (within the global network of Drug Product Pilot Plants)
* Act as System Matter Expert from a PP/Manufacturing perspective, covering multiple equipment platforms
* Support External Supply Integration of clinical manufacturing from an MST perspective when needed.
* Provide manufacturing sciences expertise to the Drug Product Development teams.
* Tech Transfer support: commercial plant readiness for registration, launch and commercial production, incl. DoE & Scale-up support.
* Concept, Design, Installation and Implementation of new equipment and PAT applications
* Support optimizations and / or changes to existing equipment to improve Pilot Plants' capability and/or capacity.
* Preferably (bio)chemical or mechanical engineering degree or equivalent with at least 2 years of experience in pharmaceutical development/engineering area.
* Knowledge of oral solid dosage, liquid and/or parenteral products, processes and technologies: conventional technologies as well as innovative technologies like spray drying, extrusion, nanomilling, continuous manufacturing, PAT…
* Knowledge of process modeling to support scale- up and transfer of processes.
* Knowledge on risk management
* Broad technical background (electrical, pneumatic, mechanics, HVAC,…)
* Basic knowledge of qualification, validation and change management systems in the pharmaceutical industry is a plus.
* Able to work in highly regulated environment (FDA/J&J standards and guidelines, general GMP guidelines)
* Builds or possesses an excellent internal and external network of manufacturing sciences, engineering and development specialists
* Project management skills
* Excellent communication skills in a global environment
* Excellent knowledge of English.
* Willing to learn Dutch
* Willing to travel (up to 30%)
Janssen Pharmaceutica N.V. (7555)