Digital Systems Engineer / Associate Engineer

Position Summary

The Digital Systems Engineer is responsible for supporting laboratory digital systems for the U.S. Quality Control organization remotely, primarily focusing on LIMS administration and master data management, with future support for LES.

Key Responsibilities

LIMS Configuration and Administration

• Configure and maintain LIMS master data, including but not limited to: Stability studies and protocols，Release testing workflows，Materials, reagents, and reference standards and Sampling plans
• User roles and permissions
• Perform routine data verification and periodic reviews of system configurations.
• Support user account administration and access control activities.
• Ensure system configurations are maintained in accordance with business requirements and quality standards.

LES Configuration and Administration

• Configure and maintain electronic workflows, forms, and execution templates within LES.
• Support the conversion of paper-based laboratory procedures into electronic workflows.
• Participate in LES implementation, validation, deployment, and lifecycle support activities.
• Collaborate with laboratory users and process owners to optimize system functionality and workflow efficiency.

User Support & Compliance

• Provide training and first-line support for LIMS and LES users.
• Ensure system-related activities comply with GMP requirements, Data Integrity principles, and company quality procedures.
• Support cross-site harmonization between U.S. and China QC organizations.

Global Support

• Provide remote support to U.S. QC operations across multiple time zones.
• Occasional international travel may be required to support business needs.

Requirement:

• Bachelor's degree or above in: Biotechnology, Pharmaceutical Sciences, Computer Science,Information Systems Or a related discipline
• Experience: 1-3 years of experience in pharmaceutical, biotechnology, laboratory operations, or computerized systems.
• Experience with LIMS, LES, Empower, LabWare or similar laboratory systems is preferred.
• Experience in a GMP-regulated environment is preferred.