Website Asset Recruitment
Job # SW2 00937
Laboratory Systems CSV Engineer
Long term contract opportunity to join a premier Biopharma manufacturing organisation based in Dundalk on an exciting project. Our client seeks an experienced Laboratory Systems CSV Engineer, proficient in Computerised Lab Analytical Equipment and Lab Information Management Systems and who will be responsible for ensuring delivery of reliable, robust, and compliant Quality Control Lab IT systems to meet business requirements. This includes integration of Chromatography systems and benchtop analytical equipment to these systems and supporting integration to other systems. If you are in search of new projects in Biopharma, we have the opportunity for you.
Working under the direction of the Lab IT Systems Project Manager and other team members from the Lab systems team delivering Lab IT systems and interfaces.
Ensure all Lab IT systems and Benchtop Analytical Equipment meet 21 CFR 11 and EU Annex 11 compliance requirements.
Lead risk assessment before test execution, including Data Integrity/ERES assessment and functional risk assessments.
Participate in creation of project deliverables such as design documents, configuration build, installation and validation activities as required by Lab IT systems project manager.
Draft test cases for QC laboratory systems.
Review vendor validation documents, including protocols and summary reports.
Participate in deviation investigations, analysis, and change assessment.
Responsible for Site Lab IT systems and systems platform strategy development including defining and maintaining Site Lab IT systems roadmap.
Assures all project work is completed in compliance with all Regulatory requirements including, Quality (cGLP/GMP’s), Global Engineering, EHS, design & construction directives, requirements & procedures.
Data Integrity Testing / ERES Preliminary Tests
Media and Backups- Verify availability of system and backup media items required for 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 client 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 / 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 325644-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
Bachelors or Master’s degree in Engineering, Information Systems, Computer Science.
5+ Years experience providing Lab IT systems solutions and support to organisations in biotechnology or pharmaceutical manufacturing industries.
2+Lab CSV experience in Life Sciences, ideally within a laboratory environment.
Experience of: Windows Server 2000, 2003, 2008, 2012, Windows NT, 98, XP, Win 7, MS Active Directory, DNS, DHCP, DFS, MS Office 2003/2010/2013, MS Office Communicator, MS Lync 2010/2013, MS SharePoint 2007/2010, LAN/WAN/VPN.
Experience with the following systems Chromatography (Empower – Waters), Lab Data Archival (Nugenesis – Waters), Electronic Methods Execution/Electronic Lab Notebook (SmartLab – Biovia) LIMS (Sample Manager – ThermoFisher), Environmental Monitoring (MODA) advantageous.
Significant knowledge of regulatory requirements relating to CSV and 21 CFR Part 11 / EU Annex 11.