GxP Systems & Validation Support Specialist

CAI; United States; Remote; USD 90,000 - 120,000; Full time

Benefits offered by this job

Health Insurance

Paid Time Off 24 days

Life Insurance

Long Term Disability

Job summary

CAI is seeking an IT Systems Administrator to manage GxP applications in a regulated environment in the United States. You will oversee Dot Compliance eQMS, Master Control CMMS, Kneat, and Valkit Digital Validation systems, ensuring configurations, upgrades, and patches adhere to change control and validation processes.

You will collaborate with vendors and internal teams to resolve issues and maintain compliance, supporting data integrity and regulatory readiness across platforms.

Qualifications

• Bachelor's degree or equivalent in IT/CS/Life Sciences.
• 3-5+ years of IT systems administration experience, 2+ in GxP environments.
• Knowledge of FDA 21 CFR Part 11, EU Annex 11, GAMP 5, Data Integrity.

Responsibilities

• Administer GxP applications including Dot Compliance eQMS, Master Control CMMS, Kneat & Valkit Digital Validation systems.
• Support system configuration, upgrades, and patches using established change control and validation processes.
• Collaborate with vendors and internal teams to resolve issues and maintain compliance.

Skills

GxP compliance knowledge

Change control

Vendor collaboration

Education

Bachelor's degree or equivalent in IT/CS/Life Sciences

Tools

Dot Compliance eQMS

Master Control CMMS

Kneat

Valkit Digital Validation

Job description

CAI is seeking an IT Systems Administrator to manage GxP applications in a regulated environment in the United States. You will oversee Dot Compliance eQMS, Master Control CMMS, Kneat, and Valkit Digital Validation systems, ensuring configurations, upgrades, and patches adhere to change control and validation processes.

You will collaborate with vendors and internal teams to resolve issues and maintain compliance, supporting data integrity and regulatory readiness across platforms.