Computer System Validation Engineer, Hoofddorp, Noord-Holland

Company
Our client is an innovative organization operating in a highly regulated manufacturing environment. The company focuses on maintaining the highest standards of quality, compliance, and operational excellence, while supporting complex technical projects that are critical to product delivery and patient safety.

Job Description
Our client is looking for a Computer System Validation Engineer to support key manufacturing system projects on site. This role is focused on quality oversight within Computer System Validation activities, with a strong emphasis on MES-related projects. The successful candidate will help ensure validation work is compliant, well documented, and aligned with GMP requirements, while supporting wider quality and risk management activities across the site.

Responsibilities
- Provide quality oversight for MES-related qualification and validation activities
- Review and approve initial validation, change-based validation, and periodic revalidation deliverables
- Support compliance with GMP and other applicable regulatory requirements
- Contribute to quality processes that help ensure high standards across manufacturing operations
- Support CQV quality oversight activities across the site
- Contribute to Quality Risk Management activities and support risk-based decision making
- Work closely with cross-functional teams to maintain alignment between quality, engineering, and operational requirements
- Help identify process improvements and support the development of quality-related KPIs
- Assess deviations from accepted practice and evaluate their potential impact
- Support inspection readiness, audits, and ongoing compliance activities as needed

Requirements
- Strong experience in Computer System Validation within a regulated environment
- Experience working with MES-related projects or systems
- Good understanding of GMP and quality compliance requirements
- Experience reviewing and approving validation documentation
- Ability to work independently while collaborating effectively with cross-functional teams
- Exposure to CQV and Quality Risk Management is preferred
- Strong communication skills and a structured, quality-focused mindset

Other Information
This is an excellent opportunity for a quality professional who enjoys working at the intersection of compliance, systems, and operational improvement in a technically advanced environment.
If you are interested and want to apply, please submit your application via the apply button below and contact me.

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