Lab Systems CSV Engineer 1243
SimoTech requires an Laboratory Systems CSV Engineer for a new large-scale biopharmaceutical project based in North Leinster. The Laboratory Systems CSV Engineer will be responsible for ensuring the delivery of reliable, robust and compliant Quality Control Laboratory IT systems to meet business requirements. This includes the integration of Chromatography systems and benchtop analytical equipment to these systems and supporting integration to other systems.
- Working under the direction of the Laboratory IT Systems Project Manager and with other team members from the laboratory systems team to deliver the Lab IT systems and interfaces.
- Draft test cases for QC laboratory systems.
- Lead the risk assessment before test execution, this includes but is not limited to Data Integrity/ERES assessment and functional risk assessments.
- Review vendor validation documents, including validation protocols and summary reports.
- Participate in deviation investigations, analysis and change assessment.
- Participate in the creation of project deliverables such as design documents, configuration build, installation and validation activities as required by the Lab IT systems project manager.
- Responsible to ensure technical delivery of Lab IT systems as endorsed by leadership team to meet business objectives.
- Ensure that all Lab IT systems and Benchtop Analytical Equipment meet 21 CFR 11 and EU Annex 11 compliance requirements.
- Responsible for Site Lab IT systems and the systems platform strategy development including defining and maintaining the Site Lab IT systems roadmap.
- Responsible for regular communication to project leadership & stakeholders.
- Assures all project work is completed in compliance with all Regulatory requirements including, Quality (cGLP/GMP’s), EHS, Global Engineering, design & construction directives, requirements & procedures, as well as all Local/Federal Regulatory requirements.
- Bachelors or Master’s Degree in Engineering, Information Systems, Computer Science or the Life Sciences.
- At least 3 years’ experience providing Lab IT systems solutions and support to manufacturing organisations in the biotechnology or pharmaceutical industries.
- At least one year CSV experience in Life Sciences, ideally within a laboratory environment.
- Experience of the following: 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 would be an advantage: Chromatography (Empower – Waters), Lab Data Archival (Nugenesis – Waters), Electronic Methods Execution/Electronic Lab Notebook (SmartLab – Biovia) LIMS (Sample Manager - ThermoFisher), Environmental Monitoring (MODA).
- Significant knowledge of regulatory requirements relating to CSV and Data Integrity including 21 CFR Part 11 / EU Annex 11.
What SimoTech Can Offer
- Role provides a high degree of autonomy to allow the successful candidate to reach their full potential.
- Develop new skills and enhance technical ability by working with innovative technologies in a multi-disciplined environment.
- Opportunity to work with large corporate clients on exciting capital projects.
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