We are looking for a CSV Engineer who can support in validation tasks for a global program started to protect this organisation against cyber treats and natural disasters. This automation program has to ensure a better protected and more resilient situation of the Lab- and Production equipment and its linked operating systems and softwares.
Several projects have already been identified by our taskforce. 25% of the projects require equipment replacements or upgrades and 75% are automation driven. Every project team exists of a Project Leader, Computer Systems Validation Engineer, Design Engineer Automation, Quality Officer and production representatives. A centralised Project Services team will support the teams with scheduling, finance and document management.
For these project teams we are currently looking for multiple Computer Systems Validation Engineers:
Your Tasks as a CSV engineer:
- Writing the Qualification Plan, Requirement Specifications, User Acceptance test protocol and Qualification Report
- Responsible for compliance with the project's requirements and the validated state
- Reporting progress deviations to the project leaders
- Reviewing of Validation documents
- Finding Initiating and realising improvement points for GMP documentation
- Being up-to-date of the newest trends in terms of Data Integrity
- Proactive and result oriented team player
- Familiar with process Automation
- Good skills in English, spoken and written
Preferably also in Dutch
- Eligible to work in the Netherlands
- Experience with Equipment/Software Validation in a GMP environment