(Junior) Process & Technology Transfer Engineer Clinical Supply Chain-00000LRW
Description
The Process & Tech Transfer engineer is responsible for engineering aspects of process development, introduction and technology transfers of DP processes from PDMS to JSC sites or to external partners :
- Support the development and implementation of new technologies/processes/PAT applications in the global network of Drug Product Pilot Plants.
- Start from the detailed knowledge of the processes during development to deliver PDMS design inputs for the receiving commercial site (URS and process requirements).
- Follow up on the progress of the project together with the Drug product Development organisation to assure timely readiness of installation at receiving site.
- Representative from the Clinical supply chain (CSC) organisation in the Drug Product Development project team.
Activities include:
- Process engineering expertise input to the Drug Product Development teams.
- Tech Transfer support: commercial plant readiness for registration, launch and commercial production, incl. DoE & Scale-up.
- Concept, Design, Installation and Implementation of new equipment and PAT applications.
- Support optimizations and / or changes to existing equipment.
- Follow up of clinical batches planning, start and follow up at external partners (Supply execution role).
Qualifications
- Preferably chemical or mechanical engineering degree or equivalent, with at least 2 years of experience in pharmaceutical development/engineering area.
- Knowledge of liquid, parenteral and/or solid oral dosage products, processes and technologies: conventional technologies as well as innovative technologies like spray drying, extrusion, nanomilling, nasal delivery platforms, continuous manufacturing, PAT…
- Knowledge of process modeling to support scale- up and transfer of processes.
- 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).
- Able to build or possesses an excellent internal and external network of engineering and development specialists.
- Excellent English communication skills in a global environment.
- Willing to travel (up to 30%).
CBLD-BE
Primary Location:Europe/Middle East/Africa-Belgium-Antwerp-Beerse
Organization: Janssen Pharmaceutica N.V. (7555)
Travel:Yes, 25 % of the Time
Job Function: Process Engineering
Description
The Process & Tech Transfer engineer is responsible for engineering aspects of process development, introduction and technology transfers of DP processes from PDMS to JSC sites or to external partners :
- Support the development and implementation of new technologies/processes/PAT applications in the global network of Drug Product Pilot Plants.
- Start from the detailed knowledge of the processes during development to deliver PDMS design inputs for the receiving commercial site (URS and process requirements).
- Follow up on the progress of the project together with the Drug product Development organisation to assure timely readiness of installation at receiving site.
- Representative from the Clinical supply chain (CSC) organisation in the Drug Product Development project team.
Activities include:
- Process engineering expertise input to the Drug Product Development teams.
- Tech Transfer support: commercial plant readiness for registration, launch and commercial production, incl. DoE & Scale-up.
- Concept, Design, Installation and Implementation of new equipment and PAT applications.
- Support optimizations and / or changes to existing equipment.
- Follow up of clinical batches planning, start and follow up at external partners (Supply execution role).
Qualifications
- Preferably chemical or mechanical engineering degree or equivalent, with at least 2 years of experience in pharmaceutical development/engineering area.
- Knowledge of liquid, parenteral and/or solid oral dosage products, processes and technologies: conventional technologies as well as innovative technologies like spray drying, extrusion, nanomilling, nasal delivery platforms, continuous manufacturing, PAT…
- Knowledge of process modeling to support scale- up and transfer of processes.
- 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).
- Able to build or possesses an excellent internal and external network of engineering and development specialists.
- Excellent English communication skills in a global environment.
- Willing to travel (up to 30%).
CBLD-BE
Primary Location:Europe/Middle East/Africa-Belgium-Antwerp-Beerse
Organization: Janssen Pharmaceutica N.V. (7555)
Travel:Yes, 25 % of the Time
Job Function: Process Engineering