System Manager

  • Category
    Engineering
  • Location
    Raleigh, North Carolina
  • Type
    Direct hire

We are looking for a System Manager who will be responsible for system management of assigned regulated IT Systems. This includes the full systems life cycle management including system development, system maintenance & operation, compliance to regulatory & requirements, incident & change management & retirement of systems. You will also be responsible for:

  • Systems Management:
    • Ensures system compliance with relevant internal SOPs & guidelines as well as external requirements (21CFR Part 11, Personal Data Protection, SARBOX, etc.)
    • Reviews & maintains all IT CSV Validation/System Decommissioning documentation in accordance with regulatory & Novo Nordisk requirements
    • Provides input on System Life Cycle management & suggests inputs for the IT roadmap
    • Documents Operation & Maintenance of the system (incident management, contract/SLA Management, data integrity/retention/archive, continuity/recovery plans)
    • Performs system reviews to ensure basic IT controls are in place & in control to ensure compliance/security of the system
    • Reviews & approves testing protocols to ensure requirements are tested appropriately
    • Participates in Root Cause Analysis for deviations within supported IT Systems to ensure effective corrective actions are identified & implemented
    • Audit & Inspection support
  • Documentation
    • System documentation including ensuring operational manuals, system architecture, data flows, etc. are complete
    • Works with Subject Matter Expert (SME) to ensure system documentation is in compliance with local, corporate & regulatory regulations
    • Documentation of system configuration baselines
  • Security
    • Approves appropriate access to new users & removes access as necessary
    • Works with IT Security/SME to ensure controls are in place & documented
    • Performs annual system evaluation
  • System Support
    • Serves as the escalation point for system support
    • Ensures end user training is in place as required
    • Prepares support agreements with internal & external sources.
    • System Projects: Performs activities assigned within agreed timelines
    • Maintains a safe work environment
    • Other accountabilities, as assigned

 

To be successful as a System Manager you will need:

  • 5-8+ years engineering experience in process-based manufacturing, utility, and/or packaging systems.
  • Experience with production manufacturing, IT Projects & management of IT systems
  • Technical/Process/Functional Knowledge
  • IT frameworks such as COBIT, ITIL, GAMP, 21CFR Part 11, and/or PIC/S Annex 11
  • System development lifecycle including validation of computer systems, operation & maintenance & decommissioning of systems
  • Manufacturing processes for manufacturing areas (aseptic, inspection, assembly, packaging, utilities & laboratories).
  • Expert in GxP documentation practices



 

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