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Operational Technology Engineer

Onsite, Kulim, Kedah

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Job ID: R-531687
Category: Information Technology
Location: Kulim, Malaysia
Region: APAC

Job Description Summary

Deploy Operational Technologies plantwide

Job Description

P2-12446

System Integration

Connect shop-floor equipment with the eDHR system.
Ensure real-time data capture from manufacturing processes into the eDHR.
Enable automated logging of production parameters, test results, and equipment status.

Data Accuracy & Traceability

Validate that data collected from machines is accurate and timestamped.
Ensure traceability of each device or batch through unique identifiers

System Reliability & Uptime

Maintain the infrastructure (networks, servers, interfaces) that supports eDHR operations.
Monitor system health and resolve connectivity or data flow issues promptly.
Implement redundancy and failover mechanisms to ensure continuous data capture.

Cybersecurity & Access Control

Secure OT systems against unauthorized access and cyber threats.
Manage user roles and permissions for accessing eDHR-related data.
Ensure compliance with data integrity and security standards.

Collaboration with Quality & IT Teams

Work closely with Quality Assurance to align eDHR configurations with regulatory requirements.
Coordinate with IT to ensure eDHR systems are integrated with enterprise platforms
Support audits by providing system logs and data trails.

Change Management & Validation

Participate in change control processes for updates to OT systems affecting eDHR.
Support validation activities (IQ/OQ/PQ) for new equipment or software integrations.
Document system configurations and changes for traceability

Qualifications

Bachelor’s degree in electrical engineering, Automation, Computer Engineering, Information Technology, or related field.
3–6 years of experience in Operational Technology, Industrial Automation, or Manufacturing IT.
Experience in regulated industries such as medical devices, pharmaceuticals, or semiconductors.
Hands-on experience integrating eDHR systems with shop-floor equipment.
Certifications in Industrial Automation, Networking, or Cybersecurity (e.g., CompTIA Security+, ISA/IEC 62443) are advantageous.
Familiarity with medical device regulations (e.g., ISO 13485, FDA 21 CFR Part 11) is a plus.
Experience with shop-floor equipment integration and real-time data acquisition systems.
Knowledge of MES platforms (preferably Apriso).
Proficiency in network infrastructure, server management, and interface protocols (e.g., OPC UA, MQTT).
Understanding of data traceability, timestamping, and device-level identification.
Experience in maintaining high-availability systems, implementing redundancy, and managing failover mechanisms.
Skilled in system health monitoring, connectivity troubleshooting, and data flow diagnostics.
Knowledge of OT cybersecurity best practices, including firewall configuration, access control, and threat mitigation.
Experience managing user roles, permissions, and ensuring data integrity across systems.
Ability to work closely with Quality Assurance, IT, and Validation teams to ensure regulatory alignment.
Experience supporting audits, providing system logs, and maintaining data trails.
Familiarity with change control processes and validation protocols (IQ/OQ/PQ).
Skilled in documenting system configurations, integration changes, and support activities.
Experience participating in software and hardware upgrades, environment transitions, and system validations.