CSV Engineer- MES West Dublin
Long term contract opportunity to join a premier Biopharma manufacturing organisation based in West Dublin on an exciting new project.. Our client seeks an experienced CSV Engineer, proficient in computerised Manufacturing Execution Systems (MES) to track and document the transformation of raw materials through to finished goods. If you are in search of new projects in Biopharma we have the opportunity for you.
Data Integrity Testing / ERES Preliminary Tests
Media and Backups- Verify the availability of system and backup media items required for the system.
Test Setup- Create tests accounts and test data as required
Computer Hardware and Software- Verify details of computer hardware, software and printers controlling the equipment.
Windows Security- Verify the configuration of security, including date/time, settings on the Windows system comply with Ipsen policy requirements.
User Privileges - Confirm privileges assigned to users - defined, approved, and configured correctly on system.
User Review -Verify all users - active and with access to Windows system and application are approved and assigned correct role / group.
Backups Configuration Verify the data backup tool(s) are configured to back up the required data, to the required destination at the required frequency. -
Electronic Signatures - Confirm the eSignature configuration are defined, approved and configured correctly on the system.
System Upgrade Tests
Document / verify implementation of data integrity related changes associated with system upgrade including the migration / preservation of data from the legacy system, verification that changes have been correctly implemented and the computerised system is ready for operational use.
Domain Logon and Security, Users, User Groups and Privileges, eSignatures, Report Templates, Methods
Verify legacy data from the old system is securely retained, complete and legible on new system
Tidy up data created during execution of this protocol and disable all test accounts. Confirm a concluding drive image of the system is performed. PC tidy-up, system image
Develop and execute OQ based on standard compliance tests adjusted for Karl Fischer functionality, configuration and 5 PCs.
Develop compliance assessment for system.
Compliance Summary Report
develop summary report detailing assessment and findings.
Process Data Map
Develop process/data flow map for KF system with the aid of quality control personnel.
Review Risk Assessment for Online Data Review client document (phone number removed)-FOR for system and update where required to address new functionality and/or review practice.
Online Review Form
Obsolete QC API KF Electronic Data & Audit Trail Review client document and incorporate checks into procedure (specific for product).
Explore feasibility and benefits of implementing or preparing system for future implementation of following during system upgrade.
Database Reorganisation, Data Archiving, Use of eSignature for review and approval of Determinations 3 Item Work Tasks Days, Disaster Recovery.
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