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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.

Required Skills

Optional Skills

.

Primary Work Location

MYS Kedah - Bard Kulim (Malaysia)

Additional Locations

Work Shift

MY3 Normal 8a-4.45p Group 26 (Malaysia)
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