Computer Systems Validation Engineer

Byondis

Nijmegen

Byondis is an independent Dutch biopharmaceutical company, based in Nijmegen, that focuses on developing innovative medicines against cancer and autoimmune diseases. We are driven by one goal: to develop new treatments to improve the standard of care for patients.

Your Role

The IT team at Byondis is seeking for a Computer System Validation Engineer. In this role, you will ensure that all validation activities related to computer system implementation, lifecycle renewal and upgrade projects are done properly. You have solid experience in supporting computer system validation activities for applications used in GMP (GxP) processes, ensuring compliance with internal procedures and relevant regulations such as 21 CFR Part 11, Annex 11, GMP, GAMP5, ISO27001 and SOx. You oversee and participate in IT related change control and deviation processes.

Your responsibilities include
• Safeguarding validation activities related to computer system implementation, renewal and upgrade projects... More Detail

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