Cleaning Validation Specialist-1805645534W
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.
The FPO Drug Product Pilot Plant (PP), located in Beerse and part of the PDMS-CSC organization, has a vacancy for a cleaning validation Specialist.
* Maintain the validated state of the FPO cleaning methods (+-45 equipments)
* Evaluation of cleaning aspects of new compounds at introduction
* Development/optimization of cleaning methods and practices
* Manage events/deviations/CAPA's related to cleaning issues
* Working with a team of cleaning consultants to accomplish the overall cleaning (validation) goals
* Master in Engineering, Pharmacy or in the bio/food processing area, or equivalent by experience
* Experience in a pharmaceutical environment, and knowledge of GMP systems is a plus
* Have a high quality mindset and being able to develop excellent working relationship with QA partners.
* Proficient in English and Dutch, or willing to acquire this knowledge in short term to be able to communicate on the shop floor.
* Capable of dealing with the challenges of a clinical supply chain, i.e. the flexibility that comes with the clinical demand variations and the dynamics of dealing with about 10 new compounds every year.
* Strong communication skills and capable of building good working relationships in a global development organization.
* Hands-on type manager with focus on quality, safety and productivity
Janssen Pharmaceutica N.V. (7555)