IT Labs System Engineer 1244
SimoTech require an IT Labs System Engineer to support a manufacturing benchtop equipment project within a new large-scale biopharmaceutical based in North Leinster. The Engineer will be responsible for ensuring reliable, robust and compliant manufacturing benchtop systems to meet business requirements. This includes incorporation of benchtop analytical equipment to these systems and supporting integration to other systems.
- You will work under the direction of the Project Manager and with other team members from the corporate manufacturing systems team to deliver the manufacturing benchtop equipment and interfaces.
- Actively participate in the creation of project deliverables such as design documents, configuration, installation and validation activities as required by the project manager.
- Responsible for ensuring technical delivery of manufacturing benchtop equipment as endorsed by leadership team to meet business objectives.
- Work to ensure that all manufacturing benchtop equipment meet 21 CFR 11 and EU Annex 11 compliance requirements.
- Responsible for the development of analytical equipment platform strategy development, platform architecture and system ownership.
- Assures all project work is completed in compliance with all regulatory requirements including, Quality (cGLP/GMP’s), EHS, Global Engineering, design & construction directives; in addition to 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 manufacturing systems IT solutions and support to manufacturing organisations in the biotechnology or pharmaceutical industries.
- Experience of the following: Win 10, MS Active Directory, DNS, DHCP, DFS, LAN/WAN/VPN.
- Experience with network and infrastructure fundamentals.
- Knowledge of databases, reporting and analytic systems.
- Ability to anticipate, evaluate and resolve multiple, simultaneous project issues, delays and problems by utilising technical, project management, and business expertise.
- Ability to work independently and remotely with minimum direct supervision.
- 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 Manufacturing Benchtop equipment.
- Experience with the integration of one or more of the following system types: Blood Gas Analyser, Multi-parameter Biochemical Analyser, Osmometer, Spectrophotometer, Cell culture Analyser.
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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