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MI/OT Engineer

5 months ago


Durham, North Carolina, United States bioMerieux SA Career Site - MULTI-LINGUAL Full time

Description

Position Summary:The MI/OT Engineer is responsible for the administration of MFG infrastructure networks and systems according to site quality and change control procedures This position specifically requires the administration of: VMware systems, Ethernet networks, Windows Server and Desktop operating systems, Windows Active Directory, virtual backup and restoration systems, network storage devices, Cisco switches and imaging of thin-client terminals. Additionally, this position requires the management and revision of all associated lifecycle documentation. The position acts as a site subject matter expert for MFG infrastructure related issues (operating systems, hypervisor, network and hardware) based upon good engineering practices and a risk-based approach. This position assists in the implementation of large and small scale technology projects. Implements operational technology modifications to improve safety, product quality and/or reduce costs. The position is responsible for the transfer of technology from development to implementation and performing equipment change control, verification and qualification. Evaluates technology systems to aid in solving product and process problems. Primary Duties:
  • This position requires experience in the installation, configuration, and administration of server, desktop, and lab instrument systems. This position requires the management of projects and externally sourced lab projects.
  • Conduct Failure Investigations and implement solutions (corrective and preventive actions) that solve MFG problems, follow-up on corrective and preventive actions to determine their effectiveness and suitability, and prepare written reports on these activities in a timely fashion.
  • The MI/OT Engineer executes project assignments from the beginning to successful completion and implementation with a minimum of direct supervision. The position is responsible for helping scope their specific roles in project as part scope, goals and deliverables to support business goals in collaboration with other members of the MI/OT team and project stakeholders.
  • The activities and projects will ensure that capacity needs are met and contribute to the enhancement of the Site's operational performance, through Cost / Quality / Safety.
  • Administration of: VMware systems, Ethernet networks, Windows Server and Desktop operating systems, Windows Active Directory, virtual backup and restoration systems, network storage devices, Cisco switches and imaging of thin-client terminals.
  • Provide support as a subject matter expert to maintain QC lab systems in a compliant and fit for intended use state.
  • Lead small projects and make independent decisions on operational technology problems.
  • Participate in commissioning and qualification activities (e.g. SAT, IQ, OQ) and conduct verification activities as required by the change control program.
  • Analyze computerized systems performance data to identify trends to predict potential failures and aid in solving product and process problems.
  • Review and revise Quality and Engineering documents for new and existing MFG systems.
  • This position will require some work to be done during non-standard work hours. Examples include, but are not limited to system crashes, infrastructure upgrades, hardware and/or software migrations, system validations, general maintenance activities, etc
Education, Skills & Expertise:
  • Associates degree with the following experience preferred
    • Minimum of 3 years of hands on experience designing and administering computer systems and infrastructure
    • Minimum of 3 years of hands on experience with Windows desktop and server operating systems
    • Minimum of 2 years of hands on experience with Active Directory, including Group Policies
    • Minimum of 2 years Cisco networking
    • Minimum of 1 year of hands on experience with VMware VSphere preferred
  • High school diploma/GED with the following experience required in lieu of a degree
    • Minimum of 5 years of hands on experience designing and administering computer systems and infrastructure
    • Minimum of 1 year of hands on experience with VMware VSphere
    • Minimum of 5 years of hands on experience with Windows desktop and server operating systems
    • Minimum of 4 years of hands on experience with Active Directory, including Group Policies
    • Minimum of 4 years of hands on experience with Cisco switch programming
  • Experience working with integrators / outside contractors is preferred
  • Knowledge of cGMP, validation and FDA industry experience preferred