EX: IT Lab Specialist

Pharmaron • Exton, PA

2d • Onsite

About The Position

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.

Requirements

• Bachelor's degree in Information Technology, Computer Science, or a related discipline
• 5–7 years of IT experience within GMP, GLP, or other regulated pharmaceutical or biotechnology environments
• Strong knowledge of laboratory instruments and computerized systems, including LIMS, LCMS, HPLC, Flow Cytometry, and PCR platforms
• Deep understanding of GxP compliance, data integrity principles, and regulated documentation practices
• Hands-on experience with Windows-based environments, backup and recovery technologies, and basic network infrastructure
• Experience administering databases such as Oracle and SQL Server
• Knowledge of cybersecurity principles and controls within regulated environments
• Familiarity with computer system validation (CSV), SDLC methodologies, and risk-based system assessments
• Strong analytical, organizational, and communication skills with the ability to work effectively across technical and scientific teams

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 U.S. laboratory and CGT sites may be required

Benefits

• Insurance including Medical, Dental & Vision with significant employer contributions
• Employer-funded Health Reimbursement Account
• Healthcare & Dependent Care Flexible Spending Accounts
• 100% Employer-paid Employee Life and AD&D Insurance, Short- and Long-Term Disability Insurance
• 401k plan with generous employer match
• Access to an Employee Assistance Program

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level