As a 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 Vaccine Launch Facility (VLF) for the robust and compliant implementation of the process are defined precisely.
You will be working 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.
Specific Tasks include:
- 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.
Our client is part of an international company, and develops and manufactures biologicals aiming to treat diseases in the field of cardiology, immunology and oncology.
Functie-eisenWe are looking for candidates with the following skill set:
- Bachelor / Masters degree in biotechnology, biochemistry, biomedicine, process technology (or equivalent education).
- Process Engineer 2-4 years’ experience in a biotechnology or biopharmaceutical 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:
- 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
h3 style="box-sizing: inherit; font-family: VAGRoundedStd-Light, Helvetica, Arial, sans-serif; line-height: 3rem; color: rgb(106, 116, 124); margin: 2.24rem 0px; font-size: 2.7rem;">Offer
You will be part of a dynamic and accomplished team. We offer an employment of 32 to 40 hours a week with excellent primary and secondary benefits. Moreover, Modis offers interesting benefits, like participation of our company-fitness-plan. Modis stands for innovation and stimulates new ways of working. Next to a lot of freedom, you will get the necessary amount of responsibilities, combined with the possibility to develop your ambitions and expertise. Together, we can grow.
I want to apply now
Please tell us who you are and what motivates you! We expect you to elaborate on your experience in late stage development and industrial experience. Send us your application using the application button on this website. Send us your CV + motivationletter before 26 May 2020
If you wish to receive more information first, please contact us on email@example.com or contact one of our Recruitment Consultants:
Barbara Flaton 06-2266 4285
Lars Wijnands 06-1333 9633
Cindy van Gorp 06-1278 1269