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GxP Systems and Support Administrator

4 hours, 44 minutes ago
United States
Full-time
Mid Level
Systems Administrator
DevOps and Infrastructure
Cybersecurity
Apply Now
CAI

CAI

CAI specializes in providing commissioning services that enhance the efficiency and precision of life sciences and mission-critical facilities globally.

Construction & Engineering
View All Jobs 5

Description

  • Administer Dot Compliance eQMS, Master Control CMMS, Kneat, and Valkit digital validation applications.
  • Manage user accounts, role-based access controls, and periodic access reviews.
  • Configure, upgrade, patch, and maintain systems through approved change-control and validation processes.
  • Maintain validated system status through compliant documentation and validation procedures.
  • Deploy and manage project-specific digital validation application instances for client services.
  • Support Computer Software Assurance activities, including vendor test reviews, ad hoc testing, SAT, UAT, and periodic reviews.
  • Create, review, and approve validation documentation, SOPs, work instructions, training materials, and technical documentation.
  • Perform risk and validation-impact assessments and execute documented system change controls.
  • Investigate and resolve incidents, deviations, user issues, and CAPA-related technical findings.
  • Provide Tier 1 and Tier 2 support, collaborate with vendors on defects and upgrades, and support audits, inspections, and cybersecurity initiatives.

Requirements

  • Bachelor's degree in Information Technology, Computer Science, Life Sciences, or a related field, or equivalent experience.
  • 3–5+ years of experience administering IT systems and providing technical support.
  • 2+ years of administering GxP-regulated systems in pharmaceutical, biotechnology, medical device, or similar regulated environments.
  • Experience supporting validated computer systems throughout their lifecycle.
  • Working knowledge of FDA 21 CFR Part 11, EU Annex 11, GAMP 5, data integrity, and Good Documentation Practices.
  • Experience partnering with Information Security and Quality teams to maintain internal and regulatory compliance.
  • Experience with change management, investigations, deviations, and other quality procedures.
  • Experience with Entra identity management, access controls, SSO, and SCIM integrations.
  • Knowledge of backup, recovery, and disaster-recovery procedures, with strong troubleshooting, analytical, documentation, and cross-functional communication skills.
  • Experience administering CMMS, digital validation, or eQMS platforms in a GxP environment, preferably within a professional services or consulting organization.

Interested in this position?

Apply directly on the company website

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