GxP IT Lab Systems Engineer

Pharmaron; Exton (PA); On-site; USD 75,000 - 95,000; Full time

Job summary

Pharmaron is seeking an IT Lab Systems Specialist in Exton, PA to support IT operations within a GxP-regulated laboratory environment. This role ensures laboratory computer systems and instruments operate securely and in compliance, working with QA and IT teams on implementations and lifecycle management.

Responsibilities include system backup, validation activities (IQ/OQ/PQ, CSV), documentation, access control, and collaboration with vendors to ensure regulatory and data integrity standards

Qualifications

• Experience in a GxP-regulated laboratory environment.
• Strong collaboration with QA and IT teams.
• Capability to implement and validate laboratory IT systems (IQ/OQ/PQ).
• Familiarity with data integrity and regulatory compliance requirements.

Responsibilities

• Provide hands-on IT support for laboratory instruments, applications, and computerized systems within a GxP-regulated environment.
• Troubleshoot hardware, software, and network issues in laboratory systems.
• Coordinate maintenance, upgrades, and escalations with instrument/software vendors.
• Manage backups, data integrity checks, and restore testing per internal and regulatory requirements.
• Create and maintain technical system documentation for lab instruments and interfaces.
• Support qualification and validation activities (IQ/OQ/PQ, CSV) with QA and vendors.
• Ensure compliance with 21 CFR Part 11, EU Annex 11, GDPR, and internal IT standards.

Skills

GxP compliance

IT support

LIMS/ELN

Regulatory documentation

CSV validation

Tools

LIMS

ELN

Job description

Pharmaron is seeking an IT Lab Systems Specialist in Exton, PA to support IT operations within a GxP-regulated laboratory environment. This role ensures laboratory computer systems and instruments operate securely and in compliance, working with QA and IT teams on implementations and lifecycle management.

Responsibilities include system backup, validation activities (IQ/OQ/PQ, CSV), documentation, access control, and collaboration with vendors to ensure regulatory and data integrity standards