CSV engineer
Our client is an innovative organisation in the biotechnology sector, focused on the development of advanced cell therapies. They specialise in treatments administered directly at the hospital, eliminating traditional logistical barriers in cancer care. Their approach aims to shorten treatment time and significantly improve patient accessibility.
Vacature
As a temporary Quality Equipment Specialist, you will be responsible for overseeing equipment quality within a high-tech production environment. You'll ensure proper implementation, monitoring, and documentation throughout the entire equipment life cycle. This position requires close collaboration with various technical teams and a critical approach to process and documentation compliance with internal policies and regulatory standards.
Responsibilities
Review and approve technical documentation related to equipment
Evaluate qualification protocols and reports
Ensure compliance with applicable industry standards (cGMP, FDA, ISO)
Support calibration, maintenance, and decommissioning of systems
Participate in risk assessments and follow up on deviations and corrective actions
Provide support during audits and inspections
Profile
Bachelor's or Master's degree in a technical or life sciences discipline
At least three years of experience in pharmaceutical or medical manufacturing environments
Familiarity with regulations such as cGMP and ISO 13485
Experience with equipment qualification and quality processes
Knowledge of maintenance systems and quality tools (e.g., Veeva, TrackWise)
Preferred: experience with CSV, automation systems, or Lean methodologies
Affinity with laboratory equipment is a plus
