IT Data Integrity Systems Engineer

Compliance Group Inc; North Carolina; On-site; USD 110,000 - 140,000; Full time

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

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

Key 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.

Required 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.
• Working knowledge of CSV, GxP, 21 CFR Part 11, and EU Annex 11.

Preferred Experience:

• Experience with laboratory and manufacturing equipment such as Rotea, Sepax, LOVO, Prodigy, MaxCyte, and DeltaV.
• Familiarity with instruments such as SpectraMax, Zetasizer, MACSQuant, SoloVPE, Hamilton, and BacT with MYLA software.