GMP IT Systems Engineer — CSV & Digital Projects

GMP TECHNOLOGIES (S) PTE LTD; Singapore; In loco; SGD 90.000 - 150.000; Tempo pieno

Descrizione del lavoro

GMP Technologies (S) Pte Ltd in Singapore is seeking an experienced IT systems administrator to own end-to-end system management, user access control, incident resolution, and RCA across GMP environments. The role includes leading digital projects, functional testing, UAT, and go-live hypercare for new rollouts and upgrades.

You will drive the full Computer System Validation lifecycle, developing URS/FS/RA/IQ/OQ/PQ, manage validation summaries, audits, CAPA, and change control while coordinating

Competenze

• Bachelor's degree in Information Technology, Computer Science, Engineering, or a related field.
• Minimum 3 years of experience supporting enterprise-grade manufacturing, laboratory, or related operational systems.
• Proficient in Windows Server administration, enterprise application management, and user access provisioning/revocation workflows.
• Hands-on experience with Microsoft SQL Server and SQL queries for data retrieval and issue diagnosis.
• 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).
• Experience in GMP, CDMO, or pharmaceutical industry preferred.
• Direct CSV experience preferred.
• Fluent professional English, written and verbal.

Mansioni

• Own end-to-end system administration, user access management, incident troubleshooting, and RCA for all supported systems.
• Support and have the opportunity to lead digital project execution, including functional testing, user acceptance testing (UAT), and go-live hypercare for new system rollouts and upgrades.
• Support and have the opportunity to lead the full Computer System Validation (CSV) lifecycle, including the development and review of URS, FS, RA, IQ/OQ/PQ, test management, and validation summary reports, alongside GMP compliance activities, internal and external audit support, CAPA management, and change control execution.
• Coordinate with third-party vendors on system maintenance, issue resolution, and upgrade planning, while providing Tier 2/3 end-user support for all supported tools.

Conoscenze

Windows Server administration

SQL queries

Networking basics (TCP/IP)

API understanding

Incident troubleshooting

Regulatory compliance

Formazione

Bachelor's degree in Information Technology / Computer Science / Engineering

Strumenti

Microsoft SQL Server

Descrizione del lavoro

GMP Technologies (S) Pte Ltd in Singapore is seeking an experienced IT systems administrator to own end-to-end system management, user access control, incident resolution, and RCA across GMP environments. The role includes leading digital projects, functional testing, UAT, and go-live hypercare for new rollouts and upgrades.

You will drive the full Computer System Validation lifecycle, developing URS/FS/RA/IQ/OQ/PQ, manage validation summaries, audits, CAPA, and change control while coordinating