Job Description

Your Impact

As an experienced Computerized System Validation (CSV) Engineer, you play a key role in the implementation and management of software systems used in the Life Sciences sector. More specifically, your mission is to ensure the quality and regulatory compliance of software systems used across all GxP areas. Systems in scope include site-specific lab instruments (e.g. HPLC software), production equipment (e.g. capsule filling machine), but also globally used web applications, medical devices, Clinical Trial Management Systems, complex Manufacturing Execution Systems, SAP, …

Your responsibilities include:

  • You advise the customer regarding the applicable regulations for your project/system.
  • You are responsible for defining and documenting a risk-based validation approach for your project/system.
  • You plan and manage all validation activities required for your project/system.
  • You (co-)writ...

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