IT Laboratory Systems Engineer
SimoTech requires an IT Laboratory Systems Engineer for a large scale biopharmaceutical project in Dublin. Candidates must have at least 3 years’ experience providing Lab IT systems solutions and support to manufacturing organisations in the biotechnology or pharmaceutical industries.
The IT Laboratory Systems Engineer (IT-LAB-ENG) will be responsible for ensuring reliable, robust and compliant Quality Control Laboratory IT systems to meet business requirements. This includes integration of Chromatography systems and benchtop analytical equipment to these systems and supporting integration to other systems.
- The IT-LAB-ENG 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.
- 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.
- Responsible to ensure technical delivery of Lab IT systems as endorsed by 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 lifecycle management. Site Lab IT systems platform strategy development including defining and maintaining the site Lab IT systems roadmap.
- 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 (cGLP/GMP’s), EHS, Global Engineering, design & construction directives, requirements & procedures, as well as all Local/Federal Regulatory requirements.
- Supports the project manager on schedule and budget development and control.
- Bachelors or Masters 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.
- Strong knowledge of databases, reporting and analytic systems.
- Ability to keep work pace and meet deadlines. Good organising and planning skills.
- Strong communication skills. Problem solver with a focus on achievement of overall project goals.
- Proven success working well in a team environment with flexibility to react to changing business needs.
- 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.
- Strong customer relationship management skills.
- Strong critical thinking skills.
- Industrial technology collaboration and influencing skills.
- Ensuring compliance with practices, policies, procedures, legal requirements and goals of project sponsors and approved methodologies, develop supporting documentation and monitor budget tracking/ timeliness/ scheduled resources.
- 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.