System Admin & Engineer, Digital Innovation (DI)

Position Summary This hands-on role supports the implementation, validation, administration, maintenance, and continuous improvement of manufacturing, warehouse, laboratory, quality, and asset management systems. You will support cross-functional projects, computer system validation (CSV) activities, vendor management, and end-user needs, all while upholding strict GMP and data integrity compliance standards.

Core Supported Systems: IBM Maximo, Infor WMS, Manufacturing Execution App, Manufacturing Planning App, LabX, Empower, CDS2, TOC, UV and other manufacturing or laboratory related application.

Key Responsibilities

Own end-to-end system administration, user access management, incident troubleshooting, and root cause analysis (RCA) for all supported systems

Support & opportunity to lead digital project execution, including functional testing, user acceptance testing (UAT), and go-live hypercare for new system rollouts and upgrades

Support & opportunity to lead the full CSV lifecycle (including development and review of URS, FS, RA, IQ/OQ/PQ, test management, and validation summary reports), alongside GMP compliance activities, internal/external audit support, CAPA management, and change control execution

Coordinate with third-party vendors for system maintenance, issue resolution, and upgrade planning, and provide tier 2/3 end-user support for all supported tools

Qualifications

Bachelor's degree in IT, computer science, engineering, or a related field

Minimum 3 years of experience supporting enterprise-grade manufacturing, laboratory, or related operational systems

Prior GMP, CDMO, or pharmaceutical industry experience is strongly preferred

Direct, hands-on CSV experience is strongly preferred

Technical Requirements

Proficiency in Windows Server administration, enterprise application management, and user access provisioning/revocation workflows

Hands-on experience with Microsoft SQL Server, including ability to write and troubleshoot basic to intermediate SQL queries for data retrieval and issue diagnosis

Working knowledge of GAMP 5, GMP data integrity requirements, ALCOA+ principles, 21 CFR Part 11, and Annex 11

Basic understanding of API functionality, system integration patterns, and core networking concepts (TCP/IP, DNS, VPN)

Language Requirements

Fluent professional English (written and verbal) is required (primary working language)

Mandarin Chinese is preferred, to support collaboration with regional teams, shared services teams, and cross-region vendors