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PI System Owner
PI System OwnerTechnical & Engineering Consulting • Gurabo, Puerto Rico
PI System Owner

PI System Owner

Technical & Engineering Consulting • Gurabo, Puerto Rico
Hace 6 días
Descripción del trabajo

About the Role

The PI System Administrator is responsible for overseeing and owning the OSIsoft / AVEVA PI System within a GxP-regulated Life Sciences environment, ensuring the platform remains compliant, reliable, and capable of supporting operational and regulatory needs.

Responsibilities

  • Act as System Owner for the PI System, including PI Data Archive, Asset Framework (AF), PI Vision, and PI Interfaces.
  • Perform day-to-day system administration, including user access management, security configuration, upgrades, patching, backups, and system monitoring.
  • Ensure compliance with GxP regulations, FDA 21 CFR Part 11, EU Annex 11, and ALCOA+ data integrity principles.
  • Provide support for Computer System Validation (CSV) activities, including impact and risk assessments, IQ / OQ / PQ execution, and change control.
  • Develop and maintain dashboards, reports, and data visualizations to support manufacturing, quality, and engineering operations.
  • Support internal and external audits and regulatory inspections, including documentation preparation and system walkthroughs.
  • Collaborate with IT, Engineering, Quality, and Operations teams to ensure system reliability and compliance.

Qualifications

  • Bachelor's degree in Engineering, Computer Science, Information Systems, or a related field, or equivalent relevant experience.
  • 5+ years of hands-on experience administering OSIsoft / AVEVA PI Systems in regulated environments.
  • Strong experience with CSV, GxP compliance, and Data Integrity requirements.
  • Knowledge of Life Sciences manufacturing systems is highly preferred.
  • Fluent English (spoken and written).
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    PI System Owner • Gurabo, Puerto Rico

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