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.

Job Description

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

Employment Conditions

• Region: South Holland

• Salary indication: €3,400 - €7,000 based on a 40-hour week

• Contract duration: 6 months, freelance or temporary contract

• Working hours: full-time, hybrid work model possible

• International work environment with opportunities for growth and meaningful impact

• Vacaturenummer: 26017