Process engineer equipment COVID-19
Our client is one of the biggest companies in health care, specialized in the development, production, and marketing of vaccines to prevent and combat infectious diseases. The Drug Substance Operations (DSO) department has a GMP manufacturing facility. Here medicines against diseases that have a global impact, such as vaccines against HIV, RSV, and Ebola, are produced. This is also the place where we will be producing the COVID-19 vaccine material.
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.
Wat ga je doen - What will your job be
As a Process Engineer equipment you will be the first point of contact
with Engineering, Validation, and Maintenance (EVM) to introduce new
equipment and maintain the existing equipment.
As a Process Engineer equipment you will be 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
Wat vragen wij - What are we looking for
For the position of Process Engineer equipment we are looking for a bachelor candidate with at least 4 years of relevan experience in pharma (cell culture equipment, downstream process equipment, etc.)
- Must have experience with cGMP and EHSS standards is 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
- 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)
- Dutch language skills are required
Wat hebben we te bieden - What do we offer
- Secondment for 1 year via CheckMark Labrecruitment
- Full-time position, where 32 hours a week is negotiable
- Day shift
Wil je meer weten - More information
Neem voor meer informatie contact op met Jurjen Wilschut, 0182-590 212 of 06-302 47 453