Automation Engineer

Location : Singapore Duration : 9 months Work Schedule: Full-time onsite presence The Automation Engineer – Computer Systems Compliance is responsible for ensuring the ongoing compliance, reliability, and lifecycle management of computerized automation systems supporting sterile manufacturing operations. The role ensures that all systems are maintained in accordance with approved site procedures, global standards, current Good Manufacturing Practices (cGMP), Environmental Health and Safety (EHS) requirements, Data Integrity principles, engineering standards, and applicable regulatory requirements. The incumbent supports the reliable operation of sterile manufacturing by executing scheduled Computer Systems Compliance activities, including user access management, alarm reviews, audit trail reviews, periodic system reviews, data backup and retrieval, and by managing deviations, change controls, and CAPAs. The role provides technical support for Rockwell Automation and Siemens PLC, HMI, SCADA, and virtualization (VM) applications, as well as computerized systems associated with formulation, washing, sterilization, aseptic filling, HVAC, fill-finish, and secondary packaging equipment, ensuring continuous compliance, system reliability, and operational excellence. Responsibilities: · Ensure the continued compliance of GMP computerized systems throughout their operational lifecycle in accordance with approved site procedures, global quality standards, and regulatory requirements. · Execute routine Computer Systems Compliance (CSC) activities, including: · User access management (creation, modification, periodic review, and deactivation of user accounts). · Scheduled alarm reviews. · Audit trail reviews in accordance with approved procedures. · Computerized system periodic reviews. · Data backup verification, restoration testing, and data retrieval activities. · Review of system logs and security events, where applicable. · Maintain complete, accurate, and compliant documentation for all Computer Systems Compliance activities. · Initiate, investigate, and manage Deviations, Change Controls, and Corrective and Preventive Actions (CAPAs)related to computerized systems, ensuring timely implementation and effectiveness verification. · Perform impact and risk assessments for changes affecting computerized systems and ensure compliance with change management procedures. · Support regulatory inspections, internal audits, customer audits, and quality assessments by providing documentation and technical expertise related to computerized systems. · Ensure compliance with Data Integrity requirements, including ALCOA+ principles, electronic records, electronic signatures, audit trail management, and security controls. · Collaborate with Quality Assurance, Manufacturing, Validation, Engineering, IT, and Equipment Vendors to maintain the validated state of computerized systems. · Participate in qualification, validation, and periodic review activities for GMP computerized systems in accordance with GAMP 5 and company validation standards. · Monitor system performance and identify opportunities for continuous improvement, cybersecurity enhancements, and lifecycle optimization. Equipment and Systems Supported: · Provide Computer Systems Compliance support for sterile manufacturing process equipment, including but not limited to: · IMA internal and external vial washers, Dehydrogenation and sterilization tunnels, Aseptic filling machines, Capping machines, Tray loading systems, HVAC and Building Management Systems (BMS), Steam sterilizers (Autoclaves), Parts washers, Formulation and compounding equipment, Fill-finish manufacturing equipment, Secondary packaging machines, associated PLC, HMI, SCADA, historian, and supervisory control systems supporting GMP manufacturing operations. · Support commissioning, qualification, and validation of new computerized systems. · Develop and review Validation Plans (VP), Risk Assessments, IQ/OQ protocols, Traceability Matrix, and Validation Summary Reports. · Execute validation testing in accordance with GAMP 5, CSA principles, and site validation procedures. · Review vendor documentation and Factory/Site Acceptance Test (FAT/SAT) documentation. · Ensure computerized systems remain in a validated state throughout their lifecycle. · Support implementation of cybersecurity controls including account management, patch coordination, antivirus compliance, backup validation, disaster recovery testing, and sy…