IT Lab Systems Engineer
This vacancy has now expired
An exciting project with lots of opportunities to learn new technology and develop current skills within a fast-paced new facility. This fantastic client offers the opportunity to work within a large-scale environment with cutting edge technology.
Reporting to the Lab I.T. Project Manager the I.T. Laboratory Systems Engineer will be an integral part of this established team.
You will be responsible for ensuring reliable, robust, and compliant Quality Control Laboratory IT systems to meet business requirements including the integration of Chromatography systems and benchtop analytical equipment to these systems and supporting integration to other systems.
- During the project phase, you will 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
- You will actively participate in the creation of project deliverables such as design documents, configuration build, installation and validation activities as required
- Responsible to ensure technical delivery of Lab IT systems as endorsed by the 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 life-cycle management. Site Lab IT systems platform strategy development including defining and maintaining the site Lab IT systems road map
- 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 (GCP/GMP’s), EHS, Global Engineering, design & construction directives, requirements & procedures, as well as all Local/Federal Regulatory requirements
- Gathers input and coordinates with the project team, site or Global Engineering representatives to develop requirements
- Experience providing Lab I.T. systems solutions and support to manufacturing organizations 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 Preferred: 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
- 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
The candidate must have the rights to work in the location stated in the job advert.
Please note, Quanta part of QCS Staffing does not sponsor Visa applications.
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