System Admin & Engineer, Digital Innovation

Key Responsibilities

1. Own end-to-end system administration, user access management, incident troubleshooting, and root cause analysis (RCA) for all supported systems
2. Support & opportunity to lead digital project execution, including functional testing, user acceptance testing (UAT), and go-live hypercare for new system rollouts and upgrades
3. 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
4. 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

1. Bachelor’s degree in IT, computer science, engineering, or a related field
2. Minimum 3 years of experience supporting enterprise-grade manufacturing, laboratory, or related operational systems
3. Prior GMP, CDMO, or pharmaceutical industry experience is strongly preferred
4. Direct, hands-on CSV experience is strongly preferred
5. Fluent professional English (written and verbal) is required (primary working language). Mandarin Chinese is preferred to facilitate effective collaboration with regional teams, shared services teams, and cross-region vendors.

Technical Requirements

1. Proficiency in Windows Server administration, enterprise application management, and user access provisioning/revocation workflows
2. Hands-on experience with Microsoft SQL Server, including ability to write and troubleshoot basic to intermediate SQL queries for data retrieval and issue diagnosis
3. Working knowledge of GAMP 5, GMP data integrity requirements, ALCOA+ principles, 21 CFR Part 11, and Annex 11
4. Basic understanding of API functionality, system integration patterns, and core networking concepts (TCP/IP, DNS, VPN)