Qiality Engineer

At Johnson & Johnson Innovative Medicine, they are working to create a world without disease. They bring together the best minds and pursue the most promising science.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. Why YACHT Life Sciences?
Because of challenging positions at leading (biotech) companies, a large network and development opportunities These are the advantages of working via YACHT in general and YACHT Life Sciences in particular.
Together we will look for assignments that suit your ambitions and help you to realize your goals. Through coaching, for example, but also by inviting you to interesting courses, knowledge sessions and inspiring meetings.
Yacht Life Sciences has a vacancy for a Quality Engineer to work at Johnson & Johnson Innovative Medicine in Leiden.

Your main tasks as a Senior Associate Engineer
Lead medium and high impact quality investigations (QIs) and root cause investigation, including CAPA records Act as change control (CC) lead for operations by being responsible for the change control from initiation through completion
Support process changes arising from updates to materials, equipment, facility and biotherapeutic products including new product introduction
Drive quality improvement projects within Operations Biotherapeutics in close collaboration with the stakeholders Act as a Subject Matter Expert on deviations/change controls during inspections and audits
Ensure compliant documentation and accurate completion of quality records Monitor progress and KPIs for QI/CC process
Bachelor or master’s degree in biotechnology, biochemistry, biomedicine, process technology (or equivalent education)
~2 years relevant work experience in a biotechnology or biopharmaceutical industry environment
~ Previous experience with change controls or quality investigations (pre)
~ Strong affinity / knowledge of operating systems and instrument software

This concerns a secondment contract for 1 year via Yacht. Full-time (40h) is strongly preferred, working 32 or 36 hours per week can be discussed.