(ASSOCIATE) MANUFACTURING SPECIALIST DSP
Location: Leiden, Nederland
Department: Vaccine Launch Facility. (CV19)
The Vaccine Launch Facility (VLF) is Janssen’s state-of-the-art GMP launch and manufacturing facility at the Bioscience park in Leiden. The VLF is designed to manufacture innovative biotherapeutic products for Phase III and commercial purposes and has an impressive track record of successfully launching new products in record time to patients around the globe. We are proud to work together in a Credo inspired environment where diversity and inclusion is part of our normal and daily working environment.
We are looking for an (associate) Manufacturing Specialist who will strengthen our team of 8 specialists and will take care of our Down Stream Processing (DSP) equipment. In your role as system owner, you are the first responsible person to perform acute troubleshooting and support of cGMP batches in the VLF regarding the downstream processes in the VLF (e.g. Ultrafiltration Diafiltration, clarification, chromatography and fill of Drug Substance). For this role you will play a key role in the interaction between our Production Department on one site and the Maintenance and Engineering teams on the other site. You will have to interact with people from different departments, participate in root cause investigations of complex deviations and for the implementation of preventive actions. Another essential part is to work on preventive actions, instead of responding to deviations, next to introducing new equipment to the facility.
You will become part of the Centre of Expertise (CoE) team. The CoE team consists of 8 highly skilled professionals. These manufacturing specialists and Single Use specialists, ensure that our production equipment and single use flow paths in the VLF is operational, safe, compliant, robust and ready for the future. You will have the overview and knowledge of the status of the equipment (e.g. uptime, downtime, breakdowns, lifecycle management, occupancy rate and capacity). As system owners we enable that operations can process first time right with our equipment with guidance varying from initial training, writing procedures and instructions. You will lead improvement projects to increase production capacity and will be involved by acquiring new equipment for the production facility.
Responsibilities that YOU have:
As an (associate) Manufacturing Specialist Downstream processing (DSP) you will work on safe, robust and compliant equipment, enabling operations to excel in production reliability. The duties of the Manufacturing Specialist include:
• Introduce new equipment for the manufacturing of new types of products.
• Acute troubleshoot & support production of cGMP batches in the VLF. This includes processes such as cell and virus culture, purification processes, formulation & fill and in-process testing.
• Participating in root cause investigations of complex deviations and for the implementation of preventive actions.
• Participating in handling of compliance records (change control, events, CAPA, deviations).
• Initiate, and execution of test protocols that help to improve the system or process.
• Working precisely, detecting and solving acute problems and communicate possible abnormalities.
• As equipment owner, that the production equipment is in validated state, documentation is up to date, well maintained, and capacity meets planning.
• As equipment owner, the process equipment related reports and KPI’s. You will have the overview and knowledge of the status of the equipment (e.g. uptime, downtime, breakdowns, lifecycle management, occupancy rate and capacity.)
• Leading process excellence activities to continuously improve the work as well as personal skills.
If you meet the following Job requirements, we would like to hear from YOU:
• Bachelor’s degree in biotechnology, biochemistry, biomedicine, process technology (or equivalent education).
• Associate manufacturing specialist 2-4 years’ experience in a biotechnology or biopharmaceutical industry environment. 1 -2 years for WO graduate
• Manufacturing specialist 4-8 years’ experience in a biotechnology or biopharmaceutical industry environment. 2 -4 years for WO graduate
• Experience with cGMP environment and EHSS standards is required.
• Proactively sees and finds work him/her/x self, knowing and visibly taking ownership of responsibilities
• Excellent communication skills, written and verbal in English (required) and Dutch (pre)
• Recognizes, acknowledges, and involves employees with different backgrounds, talents, knowledge and ideas