Janssen Biologics B.V. is one of the Janssen Pharmaceutical Companies of Johnson & Johnson, and is focused on the development, production and marketing of vaccines and antibodies to prevent and combat infectious diseases. At the Leiden Site, talented and multi-scaled people are working in a dynamic culture in which innovation and a 'can do' state of mind are the central points. To build up and strengthen our Operations Team in the Vaccines Launch Facility we are looking for several enthusiastic and talented
Process Engineer (Temp)
(VLF – Process, Technology and Projects)
Would you like to be directly involved in the fight against the global
"Corona virus" (COVID-19) pandemic? Then keep reading!
The Vaccines Launch Facility:
The Vaccine Launch Facility (VLF) is a state-of-the-art vaccines GMP manufacturing facility located at the Bioscience park in Leiden, where we produce vaccines against infectious diseases, such as HIV and RSV. The VLF is designed to manufacture drug substance on a 1000 L scale for Phase III and commercial purposes. As a response to the global COVID-19 pandemic the VLF has been appointed as one of the production sites for Janssen’s lead vaccine candidate against COVID-19.
The Process, Technology and Projects (PTP) team is an essential support group within the VLF. The team has two major roles
- Ensure that new vaccine processes and enabling technologies are introduced into the VLF using solid project management tools and extensive (bio)technical knowledge.
- Support existing vaccine processes and technologies by gathering and analyzing critical process data, investigating process deviations, and identifying process improvements.
The PTP team is a critical team member in any Technical transfer from the Vaccine Development And Production (VPAD) group to the large scale production Operations team within the VLF.
The PTP team works closely with internal and external parties to ensure that the implemented production process in the VLF are safe, robust, and compliant. We lead (or support) large and complex projects which ensure that the tactical and strategic goals of the VLF can be fulfilled.
The PTP team is one of 3 departments within the VLF. The other two are:
- Operations Department which are responsible for the actual on time production and delivery of the batches (incl. USP, DSP, Operations Support and the Center of Expertise)
- Process Excellence department which is focused on promoting and using process excellence tools to ensure a safe and efficient production culture.
Close collaboration with the other departments is vital to ensure that the overall VLF goals can be achieved.
As Process Engineer, you will be responsible for an assigned process (or sub process). For an existing process this means that on-going process data should be gathered and analyzed, deviations need to be investigated for potential product impact, changes should be evaluated prior to implementation and data gathered post implementation to prove that the change had the desired effect.
For new processes it means that the (small scale) developed process needs to be evaluated and the changes required within the VLF for the robust and compliant implementation of the process are defined precisely. The process engineer needs to work closely within the Technical Transfer team to ensure that the development knowledge is accurately transferred into the operational documentation.
In both situations you will work closely with the manufacturing specialists (system owners), operators, GMP specialists, Quality department and the process development group (VPAD).
The process engineer must be a Subject Matter Expert (SME) and needs to be up to speed with all developments internally as externally on the process.
As Process Engineer, you will be responsible for:
- Participates in comprehensive engineering activities to develop and implement effective, high quality processes using industry standard design methods to reduce production risk and increase manufacturability.
- Executes moderately complex design reviews and supplies feedback for improvements in manufacturability.
- Assesses equipment, material, and process performance to achieve the overall process yield goals. Performs vendor searches and equipment evaluation to ensure adequate capability to produce quality products in required quantities at an effective cost.
- Facilitates experiments and capability studies, develops process specifications, and supports design of process equipment.
- Evaluates and advises on the selection of suitable equipment for optimized process performance.
- Analysis of (new) systems and equipment with the intent of improving yield, process times and/or change over times.
- Edits and publishes process documentation and training materials for processes, materials, and equipment.
- Ensuring that the implemented process is well defined and aligned with the operational procedures.
- Supporting production of cGMP batches in the VLF. This includes processes such as cell and virus culture, purification processes, formulation & fill and in-process testing.
- Taking the lead in root cause investigations of complex deviations where there is (potentially) significant product impact and for the implementation of preventive actions.
- Initiating and handling of compliance records (change control, events, CAPA, deviations).
- Conceptualizing (process) improvements, define scope and deliverables, lead a team to implement agreed change and realize the agreed goal.
- Having the overview and knowledge of the status of the process (e.g. stability of critical parameters, ongoing investigations, registered process)
- Identifying and participating in improvement projects to increase the speed, reliability, yield or capacity of the process.
- Leading process excellence activities to continuously improve work-flows.
Note: Experience will determine the complexity of assigned issues and/or projects.
- Bachelor / Masters degree in biotechnology, biochemistry, biomedicine, process technology (or equivalent education).
- Jnr Process Engineer 0-2 years’ experience in a biotechnology or biopharmaceutical industry environment.
- Process Engineer 2-4 years’ experience in a biotechnology or biopharmaceutical industry environment. 1-2 years for WO graduate
- Snr Process Engineer 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.
- Certified (Lean) Green Belt.
- High degree of accuracy, initiative, and independence.
- Innovative and exploring person which detect abnormalities.
- Flexible, can deal with changing priorities and stress-resistant.
- Enthusiastic team player.
- “Can do” attitude, critical and proactive.
- Practical technical understanding and conceptual thinking.
- Good communication in Dutch and English, both verbally and in writing.
- Good communication and alignment on issue or change management
- Critical analysis of production issues
- Clear and Concrete Communication
- Influencing and Negotiating
- Applied Judgment
Specific Knowledge / Skill set:
- Project management.
- Pharmaceutical and/or bio processing principles typically used in Upstream and Downstream processing for vaccines manufacturing using disposable technologies (e.g. bioreactors & filtration systems)
- Design experience and working knowledge of automatic bulk filling systems for pharmaceutical material in Grade A environments and/or closed filling systems.
- Understanding of liquid freezing processes and its potential impact on vaccine storage and stability.
- Understanding of regulatory requirements and industry guidelines specific for the pharmaceutical industry and maintenance & engineering (e.g. GMP, NEN3140, VCA, CE, etc.)