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Senior IT Labs Systems Engineer 1418
Dublin
About SimoTech
SimoTech provides manufacturing automation and IT systems engineering, project management and validation services. We partner with life sciences companies to design, build, operate and optimise critical process automation systems that deliver fast track project delivery, operational efficiency, improve manufacturing agility and achieve regulatory compliance.
Why SimoTech
What is it like to work at SimoTech? With a strong collaborative teamwork culture based on respect, trust and excellence, we play a critical partnering role to our clients’ life-changing supply of products to patients. In return, there is excellent salary, career progression, educational support and much more.
Senior IT Labs Systems Engineer 1418
SimoTech requires a Senior IT Laboratory Systems Engineer for a large biopharmaceutical manufacturer in Dublin. The Senior IT Laboratory Systems Engineer will be part of a team delivering systems upgrades to existing equipment while supporting business needs and integration to other systems.
Key Responsibilities
- You will work under the direction of the IT Lab Systems Lead and with other team members from the corporate manufacturing systems team to roll out system upgrades.
- Work to ensure that 21 CFR 11 and EU Annex 11 compliance requirements are met.
- Responsible for the development of analytical equipment platform strategy development, platform architecture and system ownership.
- Assure 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.
Qualifications
- Bachelors or Master’s Degree in Engineering, Information Systems, Computer Science or the Life Sciences.
- At least 5 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.
- 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.
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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