operational technology engineer

6 days ago

Kulim, Kedah, Malaysia BD (Formerly known as Bard Sdn Bhd) Full time
  • 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 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.

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