GxP Systems & Validation Administrator - Remote

Bazeta; Northern (KY); Remote; USD 90,000 - 130,000; Full time

Benefits offered by this job

Comprehensive Health Insurance

Paid Time Off (PTO)

Life Insurance

Long Term Disability

Job summary

CAI is seeking a GxP Systems and Support Administrator to manage lifecycle administration of GxP and quality-governed systems, including eQMS, CMMS and digital validation tools. The role sits in the IT & Information Security team with cross-functional reporting to Digital & Quality teams.

You will handle user accounts, access reviews, change controls, and validation documentation while supporting CSA activities, audits, and CAPA investigations to ensure compliance and system integrity across

Qualifications

• Bachelor's degree in IT, Life Sciences, or related field or equivalent experience.
• 3–5+ years administering IT systems in regulated environments.
• 2+ years with GxP-regulated systems and validated computer systems lifecycle.

Responsibilities

• Administer GxP applications supporting infrastructure (eQMS, CMMS, digital validation).
• Perform user administration, RBAC, and access reviews.
• Manage configuration, upgrades, and validation documentation and procedures.
• Deploy project-based instances of digital validation apps for client services.
• Support CSA activities including reviews and testing and periodic reviews.
• Maintain audit trails and ensure regulatory compliance; assist audits and CAPA.

Skills

GxP systems

IT support

Regulatory compliance

Entra identity management

Documentation practices

Change management

Cross-functional collaboration

Education

Bachelor's degree in IT / Life Sciences or related field

Equivalent experience

Tools

Dot Compliance eQMS

Master Control CMMS

Kneat

Valkit Digital Validation

SSO / SCIM tooling

Job description

CAI is seeking a GxP Systems and Support Administrator to manage lifecycle administration of GxP and quality-governed systems, including eQMS, CMMS and digital validation tools. The role sits in the IT & Information Security team with cross-functional reporting to Digital & Quality teams.

You will handle user accounts, access reviews, change controls, and validation documentation while supporting CSA activities, audits, and CAPA investigations to ensure compliance and system integrity across