MST experienced engineer
Johnson & Johnson
- Beerse, Antwerpen
- Tijdelijk
- Voltijds
- Engage as pilot plant representative in the Drug Product Development and Clinical Supply Chain project teams, 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
- 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
- Technology Owner, covering multiple equipment platforms
- 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, nano milling, continuous manufacturing, PAT…
- 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
- Proficient knowledge of Dutch and English both spoken and written
- Willing to travel (up to 10%)
- Temporary position 1yr