Pharma IT Data Integrity Engineer (GxP, CSV, 21 CFR 11)

Compliance Group Inc

North Carolina

On-site

USD 110,000 - 140,000

Full time

20 hours ago
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Job summary

Compliance Group Inc. is seeking an IT Data Integrity Systems Engineer to support data integrity initiatives for QC laboratory and manufacturing equipment in a GxP-regulated pharmaceutical environment.

The role will implement and qualify backup and recovery solutions, support software upgrades and security controls, and install, configure, and maintain QC and manufacturing computer systems while ensuring CSV, GxP, and 21 CFR Part 11 compliance across operations.

Qualifications

  • Bachelor’s degree in IT or related field, or equivalent certifications.
  • 8+ years of pharmaceutical IT experience.
  • Knowledge of IT infrastructure, Linux, Windows Server, and Active Directory.
  • Experience with CSV, GxP, 21 CFR Part 11, and EU Annex 11.

Responsibilities

  • Implement and qualify Acronis backup and recovery solutions.
  • Support equipment software upgrades, security controls, and USB access restrictions.
  • Install, configure, and maintain QC and manufacturing computer systems.
  • Provide IT administration, troubleshooting, and vendor coordination.
  • Support CSV, data integrity compliance, and IT SOP/Work Instruction development.

Skills

IT infra knowledge
CSV & GxP compliance
AD / Windows / Linux

Education

Bachelor’s degree in IT or related field

Tools

Acronis backup

Job description

Compliance Group Inc. is seeking an IT Data Integrity Systems Engineer to support data integrity initiatives for QC laboratory and manufacturing equipment in a GxP-regulated pharmaceutical environment.

The role will implement and qualify backup and recovery solutions, support software upgrades and security controls, and install, configure, and maintain QC and manufacturing computer systems while ensuring CSV, GxP, and 21 CFR Part 11 compliance across operations.

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