IT Lab Systems Engineer 1133
SimoTech requires an IT Laboratory Systems Engineer for a new large-scale biopharmaceutical project based in Ireland. The IT Laboratory Systems Engineer will be responsible for ensuring reliable, robust and compliant Quality Control Laboratory IT systems to meet business requirements.
- Work under the direction of the Laboratory IT systems project manager and with other team members from the corporate laboratory systems team to deliver the Lab IT systems and interfaces.
- Actively participates 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.
- Site Lab IT systems including analytical equipment platform architecture, system ownership and lifecycle management. Site Lab IT systems platform strategy development including defining and maintaining the site Lab IT systems roadmap.
- Responsible for regular communication to project leadership & multi-functional team 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.
- 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).
- Experience with designing information interfaces, data conversion, and network and infrastructure fundamentals.
- Strong knowledge of databases, reporting and analytic systems.
- Ensuring compliance with practices, policies, procedures, legal requirements and goals of project sponsors and approved methodologies, develop supporting documentation and monitor budget tracking/ timeliness/ scheduled resources.
- Thorough knowledge of Pharmaceutical Industry Regulations (cGMP/cGLP, OSHA, EPA/EQB) required. Strong working knowledge of 21 CFR 11 compliance requirements as they relate to Lab IT systems.
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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