PDAP - Senior Automation Systems Engineer

【Job Overview】 As a Senior Automation Systems Engineer, this role is designed to lead integration of automated machinery into SHL IT and manufacturing operation systems to execute the development, implementation, and qualification of data handling systems for automated equipment. You will work closely with external vendors and SHL IT teams, ensuring seamless integration from development to qualification. This role also requires expertise in Data base, Networks, MES, ERP, Windows domain integration, and cybersecurity to support scalable and secure automation processes. 【Main Responsibilities】 （１） Data Handling System Development: • Define user requirements for data handling systems for fully automated machines, covering production operational requirements (e.g., regular checks, HMI, user management, equipment modes, feeding/unloading systems), quality control (QC sampling, production reporting, OEE), and IT/OT system integration in compliance with GAMP 5. • Collaborate with external vendors and internal IT teams to develop, test, integrate, and qualify systems. • System Integration and Network Management • Integrate equipment into the SHL network, ensuring seamless data exchange with MES, ERP, and Windows domain environments. Develop secure data exchange strategies using OPC UA for IT and OT system integration. • Communicate and collaborate with vendors to align on network architectures, including Layer 2/Layer 3 designs, VLAN segmentation, and subnet planning, ensuring compatibility with SHL’s IT infrastructure. • Develop network infrastructure stategies for IT and OT systems, including switches, routers, firewalls, and industrial Ethernet devices such as PROFINET and EtherNet/IP. • Troubleshoot network-related issues during machine development, qualification, and operational phases to minimize downtime and maintain system reliability. （２）Regulatory and Compliance: • Ensure compliance with 21 CFR Part 11, including electronic record management, audit trail, and user permissions. （３）System Qualification: • Lead the integration and qualification of new automated equipment with existing IT/OT systems, ensuring regulatory compliance and seamless operations. • Develop and execute validation protocols aligned with 21 CFR Part 11. Assist in Documentation completion and review including and not limited (internal guide line and rules, URSs (User Requirement Specification), SDS (Software Design Specification), FAT, SAT) （４）Cybersecurity and Compliance: • Work closely with the IT team to implement cybersecurity measures, protecting both IT and OT data integrity. • Maintain compliance with 21 CFR Part 11 and other relevant standards. （５）Continuous Improvement • Optimize data handling and system integration through data analysis, performance monitoring, and upgrades. • Develop automation tools and algorithms for real-time data analysis and system optimization. • Collaborate with cross-functional teams to improve both mechanical and control aspects of automated equipment. • Documentation and Reporting • Maintain detailed and accurate documentation for IT/OT integrations, cybersecurity measures, and compliance activities. • Develop and update Guidelines, Work Instructions (WIs), and Standard 　Operating Procedures (SOPs) to standardize IT/OT processes and ensure consistent implementation. • Facilitate regular reviews and updates of documentation to reflect changes in processes, technologies, and compliance standards.