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MST experienced engineer - 2406166370W
Description
Janssen Pharmaceutica NV, a Johnson and Johnson company, is recruiting for an MST Experienced Engineer , located in Beerse, Belgium ( Temporary position 1yr).
The MST Engineer is responsible for successful introduction and follow-up of clinical manufacturing activities in the Drug Product (DP)-Pilot Plant (PP) within PSES (Pharmaceutical Supply and Engineering Sciences), being the PP-representative in the drug product development teams. The engineer supports process development, plant introduction, scale-up & tech-transfer of DP processes from DPDS to JSC from a (clinical) manufacturing perspective. The MST Engineer is also technology owner of technologies within the DP PP. The technologies of the pilot plant include equipment for oral solids, liquids and parenteral production, both GMP and non-GMP, ranging from small scale to large scale processes e.g. from a single punch tablet press to a continuous manufacturing line and e.g. syringe and vial filling lines for parenteral production.
Key Responsibilities:
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
Activities include:
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.
Qualifications
Education:
Experience and Skills:
Preferred:
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
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com .
Primary Location Europe/Middle East/Africa-Belgium-Antwerp-Beerse
Organization Janssen Pharmaceutica N.V. (7555)
Job Function R&D Process Engineering
Req ID: 2406166370W