Janssen Vaccine Launch Facility (VLF), one of the Janssen Pharmaceutical Companies of Johnson & Johnson, is dedicated to bringing meaningful innovation to global health. Their teams focus on the discovery, development, manufacture and marketing of vaccines and antibodies to protect people worldwide from infectious diseases. In their organization entrepreneurial people work in a dynamic culture in which innovation and a 'can do' state of mind are the central points. In order to strengthen their team we are continuously looking for enthusiastic, talented people who have the ambition to develop themselves and can be of value to Janssen.
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 investigation 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:
• 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 the work as well as personal skills. Note: In general, the Sr role will have ownership on more complex issues or priority projects.
• Bachelor / Masters degree in biotechnology, biochemistry, biomedicine, process technology (or equivalent education).
• Process Engineer: 2-4 years’ experience in a biotechnology or bio-pharmaceutical industry environment. 1-2 years for WO graduate
• Senior 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. Competences:
Terms of employment:
We offer a challenging position which allows you to work in a dynamic and international environment, ensuring diversity in your work and creating plenty of opportunities for personal development.
We will offer a competitive benefit package in line with the seniority of the position. You will become a member of a strong professional network who shares your education, ambitions and competencies. This will enable you to interact with your colleagues and to become a member of the YACHT network, which stretches the Life Science industry. You will be challenged by your peers, you will be able to follow courses and training via our Yacht Academy in order to keep your knowledge and skills up-to-date, i.e. boosting your career through personal and scientific growth.