GxP IT & Lab Systems Specialist

MedPharm Ltd

Durham (NC)

On-site

USD 90,000 - 120,000

Full time

45 hours ago
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Job summary

MedPharm Ltd seeks an IT Operations & Scientific Systems Specialist to support IT operations and laboratory systems across Stirrup Creek and Emperor Blvd facilities. You will combine end-user support with administration of CDS, instrument PCs, and backup systems, ensuring GxP compliance and validated state per 21 CFR Part 11.

The role collaborates with QA, Laboratory, and Operations, traveling between sites and aligning IT controls with regulatory requirements.

Qualifications

  • Bachelor's degree or equivalent practical experience in IT or a scientific discipline.
  • 5+ years hands-on IT support or systems administration; at least 3 years supporting laboratory or regulated environments.
  • Strong knowledge of GxP and 21 CFR Part 11; change control and data integrity.
  • Experience with Chromatography Data Systems, preferably Waters Empower.
  • Proficiency with Windows 10/11, AD, and Microsoft 365 administration; familiarity with Windows Server.
  • Experience supporting instrument-connected PCs, lab software, imaging, backup, NAS, and virtualization.

Responsibilities

  • Provide Tier 1-2 deskside, phone, and ticket-based troubleshooting across two sites.
  • Image, deploy, patch, and maintain desktops, laptops, and peripherals; manage asset records.
  • Administer AD and Microsoft 365, including onboarding/offboarding and MFA.
  • Ensure timely Microsoft updates to endpoints and servers.
  • Support instrument PCs and CDS; manage CDS configuration and instrument integration.
  • Own backup, restore, and archiving for instrument data; perform restore tests.

Skills

IT support
GxP compliance
Laboratory systems
Windows administration
Active Directory
Microsoft 365 admin
VMware
Veeam
Networking basics
Documentation

Education

Bachelor's degree or equivalent

Tools

Waters Empower
VMware
Veeam
Intune
Synology
QNAP
Microsoft 365
Active Directory

Job description

MedPharm Ltd seeks an IT Operations & Scientific Systems Specialist to support IT operations and laboratory systems across Stirrup Creek and Emperor Blvd facilities. You will combine end-user support with administration of CDS, instrument PCs, and backup systems, ensuring GxP compliance and validated state per 21 CFR Part 11.

The role collaborates with QA, Laboratory, and Operations, traveling between sites and aligning IT controls with regulatory requirements.

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