CSV Validation Engineer

itContracting are seeking applications for the position of CSV Validation Engineer, this is a contract position based in Sligo.

Responsibilities:

* Development and execution of the qualification of Information Systems software.
* Development of life cycle documents necessary to address the validation lifecycle for Information Systems software (Planning, Risk, Implementation, and maintenance of the validated state).
* Ensure that Appropriate Systems are in place to evaluate changes to Validated/Qualified Systems from a Computer Systems/Software Validation perspective to ensure their continued validated/qualified state.
* Review/Approval of all Computer Systems/Software Validation Documentation.
* Generate 21 CFR Part11 and Annex 11 Assessments for CSV Project s
* Identify GAPs in Project delivery and report to Management
* Participate as required in project activities.
* Report and help resolve issues with respect to CSV Projects
* Maintain and support proactive communications regarding automation related activities to ensure conformance and maintain related work schedules.
* Performs effective document review to support Automation Compliance activities.

Other Duties Include.

Ensure compliance attributes with respect to 21 CFR Part 11 & Annex 11 compliance, namely:

* Security
* Audit trail
* Electronic signature
* Time synchronisation
* Data integrity
* Data migration
* Disaster recovery

Qualification, Skills and Experience required

* Bachelor’s degree in Computer Science, Computer Engineering, Computer Information Systems, plus 3 years relevant experience.
* Experience of validating/testing computer systems together with good knowledge of compliance good practise (i.e. GAMP5, 21 CFR Part 11, EU Annex 11 and GxPs). Experience of production and laboratory systems beneficial. Knowledge around MES, SAP, Plant Data Historian, Metrology Instruments and associated software. Experience of IT infrastructure qualification as per regulatory requirements. Experience in the discrete and medical device manufacturing would be a distinct advantage.

Ref: ITC1239

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For further information please send your CV to us. Your application will be treated in the strictest confidence.
itContracting is Ireland’s key provider of IT Contract and Permanent Professionals.

Please be advised you will receive an automated response to acknowledge receipt of your application.