GxP IT Lab Systems Engineer

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

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.