For one of the biggest biopharma companies in the world, we are looking for an (Associate) Engineer Process Equipment.
The Engineer process equipment is 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.
As (Associate) Engineer process equipment, you will:
- be the first departmental contact for questions about equipment
- lead to assure the availability of compliant equipment and processes in the department
- be expert about equipment data integrity topics in a cGMP environment
- 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
- HBO with 4-6 years’ experience in the pharmaceutical industry/biotechnology (cell culture equipment, downstream process equipment, etc.)
- Experience with cGMP and EHSS standards is required. Proven experience with handling change controls, deviations, etc.
- Lean green belt certification is preferred
- Project leadership skills
- 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)
Start Date: ASAP
If you are interested in the above description, apply with your CV
For more information, please contact Beata Wydurska on +31 (0)20 20 44 502 or at email@example.com