Key Responsibilities

Plan and coordinate work with Project Managers and Project Engineers, including tracking and reporting project progress to the project team
Lead the design, construction, and integration of OT (Operational Technology) network infrastructure, including:
Network architecture
Weak current / low-voltage systems
Production domain systems
HCI platforms Backup systems
Automation infrastructure support tools
Various automation application systems
Collaborate with the Computer System Validation (CSV) and Quality teams to ensure all project implementations meet regulatory and quality compliance requirements
Develop and execute preventive maintenance, repair, and upgrade plans for OT network infrastructure, including proper implementation and reporting
Drive continuous operation and optimization of OT network infrastructure, including:
Computer and user account management
Automation system integration
Service performance optimization
Data collection and backup management
Security audits and compliance
Develop and maintain OT construction, operations, and maintenance documentation, including:
Technical guidelines and strategies
System documentation
Standard Operating Procedures (SOPs)

Requirement

Education: Bachelor’s degree or above
Minimum 5 years of relevant professional experience
Familiar with GMP regulations in the pharmaceutical industry
Good understanding of Computer System Validation (CSV) processes
Experience in network infrastructure solutions within the biotechnology or pharmaceutical industry
Proven capability to design and build network infrastructure system
Working knowledge of GAMP 5 and validation lifecycle practices

Infrastructure Engineer