Senior CSV Consultant

Karwell Technologies
  • Gresham, OR
  • Instant Apply
30+ days ago

Job Description

Roles & Responsibilities:
  • Implement and validate computerized systems including PCS (DeltaV), Rockwell, MES (Syncade), SCADA, and PLC.
  • Author, review, approve, and execute Computer System Validation (CSV) lifecycle documentation.
  • Manage CSV projects, including team coordination, scheduling, reporting, and KPIs.
  • Perform change assessments for DCS (DeltaV) and MES (Syncade) systems.
  • Support commissioning and qualification of DCS software, particularly DeltaV.
  • Ensure compliance with regulatory standards like 21 CFR Part 11 and Annex 11.
  • Collaborate effectively in both independent and team-oriented work environments .

Numbers & Facts

LocationGresham, OR

Skills

  • Code of Federal Regulationsunmatched
  • Commissioningunmatched
  • Computer Systemsunmatched
  • Consultingunmatched
  • DeltaVunmatched
  • Distributed Control Systems (DCS)unmatched
  • Documentationunmatched
  • Maintain Complianceunmatched
  • Performance Metricsunmatched
  • Programmable Logic Controller (PLC)unmatched
  • Project/Program Managementunmatched
  • Regulatory Complianceunmatched
  • Supervisory Control and Data Acquisition (SCADA)unmatched
  • System Validationunmatched
  • Team Lead/Managerunmatched
  • Team Playerunmatched
  • Writing Skillsunmatched

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