Website Asset Recruitment

Asset Recruitment

#01035

IT Labs Engineer

Job Description

To act as the OT system Owner with responsible for all IT/OT aspects of Laboratory and production IT systems and associated infrastructures. This individual will provide front line support for operational issues, asset replacement, system upgrades on all Laboratory and Production OT systems including Empower, Karl Fisher, Pharmasuite.
Act as additional support to OT team with shared responsibilities for all IT/OT infrastructures and Cyber Security: Support the local IT/OT infrastructures including Computer room(s), Network equipment, OT Servers and Workstations, printers, scanners, and any other system’s related equipment in the scope of OT.

Responsibilities:
Site Support for Laboratory and Production OT Systems:
• Front line support for breakdowns and other operational issues with site OT systems in order to achieve manufacturing, quality and R&D objectives.
• Troubleshoot Operating System and Software issues if required.
• Provide technical hardware, software and coding expertise to ensure systems are provided and maintained to meet business compliance and performance requirements.
• Establish appropriate maintenance strategies for individual Laboratory / Production OT systems commensurate with the impact on product Quality and business interruption.
• Support the Engineering Maintenance function to ensure that all Laboratory / Production OT systems are maintained to meet the associated operational risks in the areas of GMP Compliance, Business and EHS.
• Ensure robust obsolescence strategy in place for site Laboratory / Production IT systems.
• Manage miscellaneous ‘small / medium projects’ for use in a GLP environment according to GAMP 5 and CFR 21, which will include; responsibility for management & co-ordination of project definition, engineering design, purchasing, installation, commissioning & qualification of equipment.
• Act as technical point of contact for Laboratory and Production OT systems for capital projects.
• Contribute to the development, implementation, and maintenance of a Good Engineering Practice platform for effective delivery of projects / equipment operation.
• Act as subject matter expert for Laboratory and Production OT systems for both internal and external audit.
• Proactively engage with Quality and Laboratory teams to encourage the use of technology to maximize efficiency, capacity and reliability or operations
• Generate standard specifications for Laboratory and Production OT systems.
• Act as job controller for external resource.

Site Support for Local IT-OT infrastructures:
• Maintain operating conditions and ensure the overall availability of physical infrastructure and logical resources.
• Ensure proper monitoring and backup of OT systems.
• Monitor and analyse performance, implement measures to improve quality or productivity.
• Update procedures, manuals, and documentation.
• Provide support to Manufacturing Printers

Qualifications, Skills & Experience:
• Bachelor’s Degree in Engineering, Information Systems, Computer Science, Life Sciences or related field
• 3+ years’ IT support to manufacturing organisations in a regulated industry. Ideally, hands-on experience providing Lab IT systems support (Empower etc.) in the biotechnology or pharmaceutical industries.
• 2+ years’ hands-on experience with Control System Validation (CSV) activities within a regulated Industry.
• 1+ years’ hands-on experience with MES application IT Administration support.
• Knowledge of regulatory requirements such as EU cGMPs, FDA, Annex 11/21CFR Part 11, GAMP 5 and data integrity guidelines.
• Experience in supporting infrastructures and applications; or equivalent position.
• Experience of server and/or workstation platforms, but physical and vitrual.

 

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