Remote GxP Systems & Support Administrator

Jobicy; Northern (KY); Remote; USD 130,000 - 150,000; Full time

Job summary

CAI is seeking a GxP Systems and Support Administrator to manage validated IT platforms including eQMS, CMMS and Digital Validation within our IT & Information Security function. You will handle access control, change management, deployment, testing and lifecycle validation in a regulated life-sciences environment.

The role requires 3–5+ years in GxP systems, knowledge of 21 CFR Part 11 and EU Annex 11, and experience with Entra, SSO, SCIM integrations.

Qualifications

• Bachelor’s degree in Information Technology, Computer Science, Life Sciences, or 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 a pharmaceutical/biotech/medical device setting.
• Experience administering validated computer systems throughout their lifecycle.
• Knowledge of FDA 21 CFR Part 11, EU Annex 11, GAMP 5, and Data Integrity/GDP.
• Experience collaborating with Information Security & Quality to ensure regulatory compliance.
• Experience with change management, investigations, deviations, and other Quality procedures.
• Experience with Entra identity management, access controls, SSO & SCIM integrations.

Responsibilities

• Administer GxP applications supporting infrastructure (eQMS, CMMS, Digital Validation).
• Perform user account administration and access reviews.
• Manage system configuration, upgrades, and patches with change control & validation processes.
• Maintain validated state with documentation and validation procedures.
• Deploy project-based instances of Digital Validation apps for client services.
• Support CSA activities including vendor testing reviews and UAT.
• Participate in creation and approval of validation docs, SOPs, training materials.
• Conduct risk and validation impact assessments for changes.
• Document change controls per QMS requirements.
• Investigate and resolve incidents and deviations.
• Support CAPA investigations and audits.
• Assist in cybersecurity initiatives for regulated systems.
• Train end users on system functionality and compliance.

Skills

GxP systems administration

eQMS

CMMS

computer software assurance

FDA 21 CFR Part 11

EU Annex 11

GAMP 5

validation lifecycle

identity and access management

SSO

SCIM

Entra

Education

Bachelor’s degree in Information Technology, Computer Science, Life Sciences, or related field

Tools

Kneat

Valkit

Entra

SSO

SCIM

Dot Compliance eQMS

Master Control CMMS

Job description

CAI is seeking a GxP Systems and Support Administrator to manage validated IT platforms including eQMS, CMMS and Digital Validation within our IT & Information Security function. You will handle access control, change management, deployment, testing and lifecycle validation in a regulated life-sciences environment.

The role requires 3–5+ years in GxP systems, knowledge of 21 CFR Part 11 and EU Annex 11, and experience with Entra, SSO, SCIM integrations.