BackPosted on 26/04/2016
(junior) Engineer Manufacturing Sciences & Technology
Full time |
Salary type not mentioned
Salary not mentioned |
be 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.
be accountable for successful introduction of clinical manufacturing activities in the Pilot Plants, 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 PDMS 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
Excellent communication skills in a global environment
Excellent knowledge of English.
Willing to travel (up to 30%)
The Manufacturing Engineer is responsible for successful introduction and follow-up of clinical manufacturing activities in the DP-Pilot Plants, 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 PDMS to JSC from a (clinical) manufacturing perspective.
The PDMS Clinical Supply Chain (CSC), part of the global Janssen R&D Development organization within Johnson & Johnson holds the global responsibility for all clinical supplies of Janssen R&D. Our activities include all in-house and outsourced planning, manufacturing and distribution of clinical supplies (API, Drug Product, Packaged Clinical Supplies), through a global network. We supply more than 60.000 patients in more than 300 clinical trials every year.
Preferably bio chemical or mechanical engineering degree or equivalent with at least 2 years of experience in pharmaceutical development/engineering area.
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