Jobid=625117135086553047 (0.0989)
Senior IT CSV Engineer
Location: Leiden (NL) | Hours: 36-40 per week
This role is based in the Netherlands. Applicants must be eligible to work in the Netherlands.
As Senior IT CSV Engineer at HAL Allergy, you play a critical role in ensuring that computerized systems supporting GxP processes remain compliant, secure, and fit for intended use throughout their lifecycle. You act as the bridge between IT, Validation, Quality, and business stakeholders, ensuring that system implementations and changes are delivered efficiently without compromising compliance.
You combine strong technical expertise with extensive validation experience and are responsible for the IT side of qualification, verification, validation, and change management activities. Through a pragmatic, risk-based approach, you help drive efficient system delivery while maintaining regulatory compliance and data integrity standards.
Your tasks
Lead IT validation activities for new systems and system changes from initiation through validated go-live.
Perform risk assessments (e.g., FMEA) and define validation strategies using CSA and GAMP 5 principles.
Author and maintain validation documentation, including Validation Plans, IQ/OQ protocols, UAT documentation, SOPs, and Validation Summary Reports.
Execute and coordinate qualification, verification, validation, and configuration review activities.
Validate on-premises infrastructure, cloud platforms, and SaaS applications.
Manage system changes, impact assessments, patching, and re-validation activities through the change management process.
Ensure compliance with GxP, Annex 11, ALCOA++, and data integrity requirements.
Support supplier qualification, audits, inspections, deviations, CAPAs, and periodic system reviews.
Drive continuous improvement through automation, standardization, and risk-based validation practices.
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