IT Laboratory Systems Engineer - Pharmaceutical
- Dublin
- Contract
- Life Sciences
This vacancy has now expired
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.
The role:
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
Skills required:
- 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.
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I have always received a highly professional & personable service from the team at Quanta. They listen carefully to the specific requirements of available roles and work tirelessly to supply a pool of potential candidates and make the hiring and contract renewal process an easy activity to manage.
Global Pharmaceutical firm
We have worked together with Quanta for seven years now and have always received a professional service. Quanta’s speciality certainly lies within their technical sourcing abilities and they have met our demanding requirements time and time again. Coupled with this are the integrity of Quanta’s people and their ability to deliver.
Global Pharmaceutical firm
Once again can I via you recognise the superb support I was given before, during and after this short contract. The support, was as usual professional and every friendly.
QA Specialist
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