Access Control, Analysis Skills, Auditing, Best Practices, Biology, Biotech and Pharmaceutical, Business Solutions, Change Control, Clinical Trial, Code of Federal Regulations, Communication Skills, Computer Science, Computer Systems, Continuous Improvement, Contract Research Organization (CRO), Cross-Functional, Data Quality, Data Recovery, Database Backup, Documentation, Drug Development, Drug Discovery, External Audit, Flexible Spending Accounts, GLP (Good Laboratory Practices), GMP (Good Manufacturing Practices), GxP, Hardware Configuration Management, Healthcare, High Performance Liquid Chromatography (HPLC), Identify Issues, Information Technology & Information Systems, Internal Audit, Internet Security, Laboratory Information Management System (LIMS), Laboratory Operations, Laboratory Systems, Learning Content Management Systems (LCMS), Maintain Compliance, Manufacturing, Microsoft SQL Server, Network Connectivity, Operations Processes, Oracle DBA (Database Administrator), Oracle Database, Organizational Skills, Polymerase Chain Reaction (PCR), Pre-Clinical Development, Problem Solving Skills, Procedure Development, Process Improvement, Process Validation, Quality Assurance, Quality Metrics, Regulatory Compliance, Regulatory Requirements, Research & Development (R&D), Risk, Risk Analysis, Small Molecules, Software Configuration Management, Software Development Lifecycle (SDLC), Software Patches, Standard Operating Procedures (SOP), System Integration (SI), System Validation, Systems Administration/Management, Systems Analysis, Systems Maintenance, Technical Support, Technical Writing, Testing, Time Management, User Account Administration, Willing to Travel, Writing Skills
Position: IT Lab Specialist
Salary Range: $75,000 - $95,000
Location: Exton, PA (On-site)
About Pharmaron
Pharmaron is a global CRO (Contract Research Organization) helping pharma and biotech companies bring new therapies to life. With over 21,000 employees worldwide across 23 locations in the US, UK and China, 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 over 780 discovery projects, 1,000+ CMC programs, and 1,000+ 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 3,000 global customers. To learn more, visit www.pharmaron.com.
Job Overview 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 U.S. laboratory and CGT sites may be required
What We're Looking For
- 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
Why Pharmaron?
Pharmaron is a premier service provider for the life sciences industry. Founded in 2004, Pharmaron has invested in its people and facilities and established a broad spectrum of research, development, and manufacturing service capabilities throughout the entire drug discovery, preclinical, and clinical development process across multiple therapeutic modalities, including small molecules, biologics, and CGT products. With over 21,000 employees and operations in the U.S., the U.K. and China. Pharmaron has an excellent track record in delivering R&D solutions to its partners in North America, Europe, Japan, and China.
Collaborative Culture: You will thrive in our inclusive and collaborative environment, where teamwork and innovation go hand in hand. Here, your voice matters, and your contributions make a real impact. "Employees Number One" and "Clients Centered" are the core cultural values at Pharmaron. Our culture, which sets Pharmaron apart from other organizations, has evolved from our deep commitment to our employees, partners, and collaborators.
Benefits: As part of our commitment to your well-being, we offer a comprehensive benefits package:
- 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
How to Apply:
Ready to seize this incredible opportunity? Join us at Pharmaron and be part of a dynamic team driving innovation and excellence in biopharmaceutical research and development. Apply online today!
As an Equal Employment Opportunity and Affirmative Action employer, Pharmaron values diversity and inclusion in the workplace, fostering an environment where all individuals are empowered to succeed. Join us in our mission to make a difference in the world of life sciences.
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