GxP Systems and Support Administrator (Fully Remote)

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

• Administer GxP applications including Dot Compliance eQMS, Master Control CMMS, and 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.

Qualifications:

• Bachelor's degree in IT, Computer Science, Life Sciences, or equivalent experience.
• 3-5+ years of IT systems administration and technical support experience with 2+ in GxP-regulated environments.
• Knowledge of FDA 21 CFR Part 11, EU Annex 11, GAMP 5, and Data Integrity practices.
• Comprehensive Health Insurance coverage, 24 days of Paid Time Off, and company-paid Life Insurance.
• Company-paid Long Term Disability.
• Equal opportunity employer with a focus on diversity and inclusion.

CAI

CAI is a professional services company established in 1996 that provides accelerated operational readiness and high-standard performance for mission-critical industries. The company has grown to nearly 800 employees worldwide and fosters a culture of integrity, service, and excellence.