Parenteral and Liquid SME-engineer FPO-1805645530W
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 Parenteral and Liquid SME-engineer
Your major accountabilities will be:
* Provide specialist knowledge and leadership in Parenteral- and Liquid engineering activities.
* Oversee processes and standards to maintain and improve existing and to implement new innovative manufacturing technologies.
* Plan, design, coordinate, qualify and implement high technology equipment and/or processes for clinical production in bottles, vials and syringes
* Research and instigate new projects which lead to process/ product improvements - including moving processes from design to production and automating of existing processes.
* Act as system owner of all Parenteral and Liquid process-equipment
* Responsible for qualification and validation activities related to the equipment
* Maintain life cycle of all documents related to the clinical and operational use of the parenteral and liquid equipment
* Working closely together with Engineering consultants performing routine qualification, sterile (re)validation and support process simulation activities.
* Act as spokesperson during audits and inspections
* Be leading example for safety in daily based activities, organize and maintain HAZOP's, FMEA's…
* You have a Master degree in Mechanical or Chemical Engineering or related discipline.
* You have at least 3 years of experience in a pharmaceutical environment with experience of process engineering, automation implementation and project management.
* Having experience in parenteral and oral liquid processes/engineering is an advantage
* You can impress us with project management and team leadership experience, using different tools to plan and budget all minor and major projects
* You demonstrate analytical skills in problem solving.
* You have a quality mindset in accordance with the cGMP guidelines
* You are fluent in Dutch and English and have excellent communication skills.
Janssen Pharmaceutica N.V. (7555)