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 a (senior) Process Engineer that is a quick learner, team player and up for an adventure. You will be responsible for an assigned process and/or process step in the downstream processing area. For an existing process this means that you investigate deviations for potential product impact, evaluate changes prior to implementation and continuously improve the process. For new processes it means that you play a role in new product introductions and tech transfers. The process engineer works closely with the Technical Transfer team and with the manufacturing specialists (system owners), operators, GMP specialists and Quality department.
The Process technologies and Projects team you will take place in is an essential support group within the VLF. The team consists of ± 10 professionals. These process engineers and business excellence engineers ensure that the implemented production process in the VLF are safe, robust, agile and compliant. We lead or support large and complex projects which ensure that the tactical and strategic goals of the VLF can be fulfilled. Moreover, we blend our hearts, mind and ingenuity in continually improving our business for the upcoming years. We do this by making use of the knowledge and experience of all the VLF team members and of the knowledge in Janssen Biologics. We provide and deliver skills, experience and exposure for those who want to develop their capabilities.
Responsibilities that YOU have:
As a process engineer downstream processing (DSP) you will work on safe, robust and compliant processes, enabling operations to excel in production reliability and flexibility. The responsibilities include:
- Process ownership of downstream processing process steps such as column chromatography, ultrafiltration/diafiltration and filling.
- Supporting production of cGMP batches in the VLF.
- Initiating and handling of compliance records (change control, events, CAPA, deviations), including taking the lead in root cause investigations of complex deviations where there is (potentially) significant product impact.
- Working on new product introductions, including tech transfer activities
- Ensuring that the implemented process is well defined and aligned with the operational procedures.
- Conceptualizing (process) improvements, define scope and deliverables, lead a team to implement agreed change and realize the agreed goal.
- Leading process excellence activities to continuously improve work-flows and processes.
- Bachelor’s degree in biotechnology, biochemistry, biomedicine, process technology (or equivalent education).
- 2-4 years’ experience in a biotechnology or biopharmaceutical industry environment
- Experience with cGMP environment and project management is required
- Experience with EHSS standards and lean is a pre
- Flexible, stable 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
Are YOU interested?
If you are interested in this position and you are the enthusiastic Process Engineer Downstream Processing (DSP) who is ready for an adventure, respond to this position