Specialist IT CSV

Job Purpose

As a Specialist IT CSV, you will report to the Head of IT and play a critical role in ensuring that all IT-managed computerized systems - especially GxP-regulated and other critical systems (e.g., SOX, ISO27001) - are validated, documented, and maintained in compliance with applicable industry regulations and standards. Your work will support audit and inspection readiness, system and data integrity, and cross-functional collaboration across IT, Quality, and business teams. This is a dynamic opportunity for professionals who thrive in regulated environments and want to make a meaningful impact in biotech innovation.

Major Accountabilities

• Validation Lifecycle Management: Lead and support the full validation lifecycle for GxP and other regulated IT systems, including planning, execution, change control, documentation, periodic system reviews, retrospective system reviews when required, and continuous improvement.
• Protocol Development & Risk Assessment:  Work with MoonLake system owners to develop and execute validation protocols, risk assessments, and test plans for systems subject to GxP, SOX, ISO27001, and related standards.
• Vendor Oversight: Oversee and review vendor validation and computer system assurance activities and due diligence to ensure compliance with internal and external requirements.
• Documentation & Audit