As the (Associate) Engineer process equipment you are the first point of contact with Engineering, Validation, and Maintenance (EVM) to introduce new equipment and maintain the existing equipment. Together with the development teams and EVM, processes (in sync with cGMP regulations) are introduced in the pilot facility including documentation and training. The ultimate task is to assure equipment is available at all times to allow smooth operation activities.
- Be the first departmental contact for questions about equipment
- Lead to assure the availability of compliant equipment and processes in the department
- support troubleshooting and investigation in non-conformances (process and equipment related)
- Lead and support process excellence activities to continuously improve the work
- initiate and handle equipment related compliance records (change controls, non-conformances and CAPA records)
- Work precisely and detect opportunities for improvement with proper follow up, both on work processes as well as personal development
Our client in Leiden 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.
Drug Substance Operations (DSO) department has a GMP manufacturing facility at the Bioscience Park in Leiden where groundbreaking medicines are manufactured targeting diseases that have a global impact, such as vaccines against HIV, RSV and Ebola. This is also the place where we will be producing the COVID-19 vaccine material.
To strengthen the Operations Support Team within DSO we are looking for a GMP and Documentation specialist, to help realize the upcoming COVID-19 vaccine manufacturing campaign.
The department DSO is an international team of about 40 people working on the manufacturing of cell banks, virus seeds and clinical batches (phase I to III) to support the development of new vaccine candidates. Manufacturing activities are performed under strict cGMP regulations and the process is established together with development departments, engineering & maintenance, QC, QA and warehouse. Their passion is to deliver high-quality results to their customers and to seek for opportunities for improvement.
Within the department four teams operate, each with specific responsibilities: Preparations, Cell culture, Downstream processing and the Operations Support Team. The teams are responsible for their cGMP status by maintaining the documentation system, reporting quality issues and performing the resulting corrective actions, masterbatch documentation, training and inspection readiness.
Functie-eisenYou are suitable for the job when you have the following profile:
- Minimum HBO education in relevant field with at least 4 years’ experience in the pharmaceutical industry/biotechnology (cell culture equipment, downstream process equipment, etc.) and experience with cGMP and EHSS standards (required)
- Must have proven track record with handling change controls, deviations, etc.
- Project leadership skills (project management experience is a plus)
- Able to maintain oversight in hectic environment; able to pull relevant departments together
- Lean green belt certification is preferred
- Quality Assurance understanding of regulatory requirements and industry guidelines specific for the pharmaceutical industry and maintenance and engineering (e.g. GMP, NEN 3140, VCA, CE)
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 also expect you to elaborate on your industrial / GMP experience. Send us your application using the application button on this website. We expect you to elaborate on your industry/GMP experience. Closing date is 13 May 2020.
If you wish to receive more information first, please contact us on firstname.lastname@example.org or contact one of our Recruitment Consultants:
Cindy van Gorp on 06-1278 1269
Lars Wijnands on 06-1333 9633
Barbara Flaton on 06-2266 4285