Validation Engineer Section head1.Manage CSV department resources to cover all CSV testing for existing and new systems in site
2.Managing the coordination process of the Computer System Validation activities with both value streams and Engineering departments
3.Asses and Manage systems that have risks associated with the systems that will require testing/replacement more than the scripted schedule and assessing the existing controls and putting leverage points
4.Lead the CSV work activities, planning, and execution associated with new projects and delivery of new systems into the site
5.Responsible to ensure that security requirements for site systems is implemented and in use for both value streams and utilities systems
6.Ensure that all CSV LSOP’s, protocols and CSV master plan are in place, updated and ready for local or external audit
7.Responsible to ensure that any completed CSV documents or CAPA actions are reviewed and ready for being audited
8.Ensure deployment of effective L1 self inspection runs versus L1 plan
9.Attend or delegate Engineering and CSV tiers board on regular basis
10.Responsible to deliver Validation review testing reports for all validated systems as per Validation Review plan
11.Ensure that CSV testing execution plan, CAPA’s, CCR’s and risk actions are adhered to set plan and all related KPI’s are updated and according to plan timeline
12.Responsible to deliver and execute all CSV corrective and preventive actions (CAPA’s) generated from systems testing as per timeline
13.Avail and create full training material to be official for any CSV Engineers
14.Attend all governance meeting related to CSV activities such as quality council, RMCB,…etc., on regular basis
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