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