IT Laboratory Systems Engineer - Pharmaceutical
New state of the art Biologics facility has a contract requirement for an IT Lab Systems Engineer
Working on several new projects on site such as new equipment and instruments to the labs, we are looking for someone with previous Pharmaceutical GMP experience to work within the labs on the IT systems
You will be responsible for ensuring reliable, robust and compliant Quality Control Laboratory IT systems to meet business requirements including integration of Chromatography systems and benchtop analytical equipment to these systems and supporting integration to other systems.
Work with the Laboratory IT systems project manager 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.
- Ensure that all Lab IT systems and Benchtop Analytical Equipment meet 21 CFR 11 and EU Annex 11 compliance requirements.
- 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.
- Implementation of new systems, RAM, Solo VPE, Upgrates to old IT systems and understanding log ins. Experience of CFR part 11
- 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 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
- 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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