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CSV Engineers (Computer System Validation)

DWI Consulting Ltd

Posted on Sep 23, 2021 by DWI Consulting Ltd

Not Specified, Belgium
1 Nov 2021
Annual Salary

CSV Engineers (Computer System Validation)

We are currently looking for several CSV Engineers with varied experience for one of our large clients.

You will be required to have some of the below experience.

SAP Validation

Expert ERP Functional experience
ITS Validation
Project Management:
Analyze of requirements
Define the objectives of project team
Define the various milestones of the project
Lead the meetings of follow-up of project and project team
Lead a transverse and international workgroup
Manage the budget of the project
Define the monitoring indicators of project: KPI's

Expert ERP Functional:
Collection of the user needs and redaction of the user requirements and functional specifications.
Creation of processes for Quality Management, Production, Material Master, Supply Chain, Warehouse
Expert domain Production and Material Master
Mangement of Master Data.
Issue management and problem solving with HPQC
Training of key user

ITS Validation:
Define validation methodology and approach for computerized systems projects (ERP, SCADA, laboratory equipment's)
Write/Review URS, FS, DS validation documents
Write/Review Validation Plan and Validation Summary report
Participate in determination of process and/or system controls
Prepare and implement IQ, OQ, PQ protocols and reports
Assure traceability throughout the project's validation file
Organize and coordinate IQ, OQ, PQ activities
Analyze, interpret and document testing results
Write/Review IQ, OQ, PQ reports

MES Validation

IT Compliant Solutions engineer in the following areas and in teamwork:
- validation of MES (Manufacturing Execution System) and monitoring softwares in manufacturing
- validation of Siemens products in both laboratories and manufacturing
- validation of GxP and non GxP software for laboratories

Main tasks are as follows:
- to define the validation strategy appropriately to current reglementation
- to maintain and to ensure maintenance of documentation according to the software life cycle
- to write or to review tests and testing protocols accordingly

Please call for further details

Start ASAP

Duration: 6 months + extension

Based: Remote then on site in Belgium

Reference: 1331635798

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