IT Lab Systems Specialist

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

Benefits offered by this job

Medical Insurance

401(k) Retirement Plan

Paid Time Off

Job summary

Pharmaron Beijing Co. Ltd. seeks an IT Lab Systems Specialist to support and advance IT operations in a GxP-regulated laboratory environment. You will ensure systems and instruments operate securely and in data integrity compliance, working with QA, IT, and scientific teams.

The role involves system implementation, validation, lifecycle management, and backup processes, with occasional travel to U.S. sites. Strong knowledge of LIMS, CSV, and regulatory standards is required.

Qualifications

• Bachelor's degree in Information Technology, Computer Science, or related discipline with 5–7 years of IT experience in GMP/GLP environments.
• Experience with laboratory instruments and computerized systems within regulated environments.

Responsibilities

• Provide hands-on IT support for laboratory instruments, applications, and computerized systems in a GxP-regulated environment.
• Coordinate maintenance, technical support, upgrades, and escalations with vendors.
• Manage backups, data integrity verification, and restore testing per policies.
• Create and maintain technical system documentation for laboratory instruments and data flows.
• Author and maintain SOPs and technical documentation for IT operations and backups.
• Administer user accounts, access controls, and security permissions in line with procedures.
• Lead change control activities with impact assessments and validation documentation.
• Support qualification and validation activities (IQ/OQ/PQ and CSV) with QA and vendors.
• Ensure compliance with 21 CFR Part 11, EU Annex 11, GDPR, EO 14117 and internal standards.
• Perform system reviews, patch management, audit trails, and lifecycle assessments.
• Assist in upgrades, integrations, and migrations involving LIMS/ELN.
• Participate in audits as SME for laboratory IT systems and infrastructure.
• Train staff on IT procedures, data handling, and cybersecurity best practices.

Skills

LIMS systems

Lab instrumentation

Windows environments

Backups and recovery

Oracle/SQL Server databases

Cybersecurity

CSV/SDLC

GxP compliance

Regulatory documentation

Education

Bachelor's degree in IT/CS or related

Tools

LIMS

LCMS

HPLC

Flow Cytometry

PCR platforms

Oracle

SQL Server

Job description

Position: IT Lab Systems Specialist

Salary Range: $75,000 - $95,000

Location: Exton, PA (On-site)

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.

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 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 25,000 employees and operations in the US, UK, China, and Singapore. 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:

• Comprehensive Medical, Dental & Vision Insurance with significant employer contributions
• 401(k) Retirement Plan with generous employer matching
• Generous Paid Time Off (PTO), Paid Sick Leave & Company Holidays to support work-life balance
• Employer-funded Health Savings Account (HSA) contributions (for eligible plans), plus Healthcare & Dependent Care Flexible Spending Accounts
• 100% Employer-paid Employee Life Insurance, AD&D, Short- and Long-Term Disability Insurance
• Employee Assistance Program (EAP), mental health resources, and wellness programs
• Family-friendly benefits, including fertility support and maternity resources
• Professional development and career growth opportunities within a leading global CRO/CDMO

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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