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# CSV Engineer

- **Company:** Hays
- **Location:** Amsterdam, Netherlands
- **Experience:** Expert
- **Salary:** €7,083.0
- **Contract:** Temporary contract
- **Skills:** Failure Mode Effects Analysis, System Testing, Computerised Systems, GXP
- **Published:** August 7, 2026
- **Apply:** https://www.adzuna.nl/details/5831664094

## About the Role

* 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.

## Description

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.


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