IT Lab Systems Specialist

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

About Pharmaron

Pharmaron is a global contract research and manufacturing organization (CRO/CDMO) helping pharma and biotech companies bring new therapies to life. With over 25,000 employees worldwide across 28 locations in the US, UK, China, and Singapore, we support drug discovery through to manufacturing with fully integrated high-quality services.

We're proud of the impact we make and just last year, we supported 887 discovery projects, 1,100+ CMC programs, and 1,397 clinical trials across all phases. Our teams are involved in everything from small molecules, ADC's, biologics, and gene therapies and we work with more than 3,300 global customers. To learn more, visit www.pharmaron.com.

Position

IT Lab Systems Specialist

Salary Range

$75,000 - $95,000

Location

Exton, PA (On-site)

What You'll Do

Reporting to the Director of IT, the IT Lab Specialist plays a critical role in supporting and advancing IT operations within a GxP-regulated laboratory environment. This position ensures that laboratory computer systems, connected instruments, and supporting infrastructure operate securely, reliably, and in full compliance with regulatory, quality, and data integrity standards. Working cross-functionally with Scientific Operations, Quality, and IT teams, the IT Lab Specialist supports system implementation, validation, lifecycle management, backup and recovery processes, and continuous improvement initiatives across laboratory technologies.

Key Responsibilities

• Provide hands-on IT support for laboratory instruments, applications, and computerized systems within a GxP-regulated environment Troubleshoot and resolve hardware, software, and network connectivity issues related to laboratory systems and instruments (e.g., Cell Counters, Flow Cytometers, LIMS, PCR systems)
• Partner with instrument and software vendors to coordinate maintenance, technical support, upgrades, and escalations
• Manage system backups, data integrity verification, and restore testing in accordance with internal policies and regulatory requirements
• Create and maintain technical system documentation for laboratory instruments, including hardware/software configurations, architecture, interfaces, and data flow mappings
• Author and maintain SOPs and technical documentation supporting laboratory IT operations, backup processes, and system administration activities
• Administer user accounts, access controls, and security permissions in alignment with established procedures and segregation of duties requirements
• Serve as the document owner for IT-related GxP procedures, including system administration, backup/restoration, and user management processes
• Support qualification and validation activities (IQ/OQ/PQ and CSV) for laboratory systems in collaboration with QA and external vendors
• Ensure compliance with 21 CFR Part 11, EU Annex 11, GDPR, EO 14117, and internal IT and quality standards
• Lead and support change control activities, including impact assessments, risk evaluations, testing coordination, and approval documentation for system updates and configuration changes
• Perform periodic reviews of computerized systems, including patch management, audit trail reviews, and lifecycle assessments
• Support laboratory system upgrades, integrations, and migrations involving enterprise platforms such as LIMS and ELN
• Participate in internal and external audits as the subject matter expert (SME) for laboratory IT systems and infrastructure
• Train and support laboratory personnel on IT procedures, system usage, data handling, and cybersecurity best practices
• Collaborate with cross-functional IT teams to ensure operational continuity and timely resolution of technical issues across laboratory and business systems
• Occasional travel to