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GxP Systems and Support Administrator

2 hours, 1 minute ago
United States
Full-time
Mid Level
Technical Support Engineer
Database Administration
Cybersecurity
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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 9

Description

  • Administer Dot Compliance eQMS, MasterControl CMMS, Kneat, Valkit, and related GxP applications.
  • Manage user accounts, role-based access, access reviews, SSO, and system entitlements.
  • Configure, upgrade, patch, and maintain validated systems through change control and validation procedures.
  • Deploy and manage project-based Digital Validation application instances for client services.
  • Support CSA activities, system testing, periodic reviews, validation documentation, SOPs, and training materials.
  • Investigate and resolve incidents, deviations, defects, and user-reported issues; support CAPA investigations.
  • Execute system change controls, risk assessments, and validation impact assessments in accordance with QMS requirements.
  • Support internal, supplier, customer, and regulatory audits while ensuring compliant audit trails, electronic records, and signatures.
  • Manage Tier 1 and Tier 2 technical support and collaborate with vendors on defects and upgrades.
  • Support cybersecurity initiatives, including vulnerability remediation, security monitoring, and entitlement reviews; train end users.

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 experience administering GxP-regulated systems in pharmaceutical, biotechnology, medical device, or related 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 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.
  • Strong troubleshooting, analytical, documentation, communication, and cross-functional collaboration skills.
  • Preferred: Experience administering CMMS, DVT, or eQMS platforms, particularly within a professional services or consulting organization.

Interested in this position?

Apply directly on the company website

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