TestRole127AT_GREECE
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, is recruiting Engineering team lead qualification/validation
Focus areas for the FPO PP include:
- Late stage Oral Solid Dosage forms using Continuous Manufacturing technology, which is currently being installed in our facility and which will fundamentally change the development and manufacturing of oral solid dosage forms in the near future.
- Early development in the liquids/parenteral area for both Small Molecules and Large Molecules (monoclonal Antibodies)
- Reliability, flexibility and innovation
Activities: Coordinating external engineering services and Janssen technical services department activities supporting FPO and P&L including:
- Facility and utility follow up
- Engineering and qualification activities for new equipment and changes to existing equipment
- Sterile (re)validation activities
- Automation activities
- Cleaning validation
- Spokesperson during audits for these area’s
- Responsibility for Capex
Profile:
- Master in Engineering, Pharmacy or in the bio/food processing area, or equivalent by experience
- Strong leadership profile.
- At least 3 years of experience in a pharmaceutical environment, with detailed knowledge of GMP systems.
- Proficient in English and Dutch.
- 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, including Quality assurance.
- Hands-on type manager with focus on quality, safety and productivity.