CSV Engineer

About the RoleWe are currently seeking a Senior Quality Engineer I - CSV to support a leading cell therapy organisation in Hoofddorp. In this position, you will provide quality oversight across several Manufacturing Execution System (MES) projects, ensuring validation activities are executed in line with GMP and regulatory requirements.You will work closely with Quality, Validation, Manufacturing and Engineering teams, supporting the qualification, validation and ongoing compliance of critical computerised systems., * Provide quality oversight for MES qualification and validation activities.

• Review and approve CSV deliverables, including initial validation, change controls and periodic revalidation documentation.
• Support CQV and Quality Risk Management activities across the site.
• Ensure compliance with GMP requirements and internal quality standards.
• Contribute to quality improvement initiatives and KPI development.
• Support deviation assessments, audits and inspection readiness activities.
• Partner with cross-functional stakeholders to maintain validated and compliant systems.

• Bachelor’s degree in a scientific or engineering discipline.
• Experience within a GMP-regulated pharmaceutical, biotechnology or medical device environment.
• Strong background in Computer System Validation (CSV).
• Experience reviewing validation and qualification documentation.
• Excellent stakeholder management and communication skills.
• Hands-on experience with Werum PAS-X is essential.

Preferred:

• Experience supporting MES projects.
• Knowledge of Quality Risk Management methodologies (FMEA, HACCP).
• Familiarity with Six Sigma and continuous improvement principles.

What you’ll get in return Hays Detachering | This is a project that will start with a contract for 12 months through Hays. Extension to stay within the department is anticipated. At this position, you will get a competitive salary (starting from €85,000) and your travel expenses are covered. Your new company Our client is dedicated to achieving one of the most ambitious goals of 21st-century medicine: curing cancer. This mission is at the heart of everything they do, from early research to product development. They have been at the forefront of cancer immunotherapy and today are a leader in engineered T-cell therapy, changing the paradigm of cancer treatment with what is potentially the biggest breakthrough since the introduction of combination chemotherapy more than 60 years ago. With an unrelenting drive and a singular focus on cell therapy, their team is executing on a strategy to bring life-saving therapies to patients. What you need to do now If you are interested in this role as Quality Engineer CSV, click ‘Apply now’ to send an up-to-date CV, or give us a call! Is this job isn’t quite right for you, but are you still looking for a new position? Please contact us for a confidential discussion on your career.#1050429 Deze baan Landelijk gemiddeld Vacatures Ander of Algemeen gemiddeld Noord-Holland gemiddeld