Operational Technology Engineer

BD (Tissuemed Ltd); Kulim; On-site; MYR 70,000 - 90,000; Full time

Job summary

A leading technology company is seeking an Operational Technologies Engineer to deploy plantwide operational technologies and ensure system reliability in Kedah, Kulim. Responsibilities include integrating shop-floor equipment with eDHR systems, maintaining infrastructure, and ensuring data accuracy and traceability. The ideal candidate should have a Bachelor's degree in a related field and experience in regulated industries. Cybersecurity knowledge is advantageous. This role offers a competitive salary in a dynamic work environment.

Qualifications

• 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 are advantageous.
• Familiarity with medical device regulations is a plus.

Responsibilities

• Deploy Operational Technologies plantwide.
• Connect shop-floor equipment with the eDHR system.
• Ensure real-time data capture from manufacturing processes into the eDHR.
• Maintain the infrastructure supporting eDHR operations.
• Work closely with Quality Assurance to align eDHR configurations.

Skills

Electrical engineering

Automation

Computer Engineering

Information Technology

Operational Technology

Industrial Automation

Manufacturing IT

Cybersecurity

Networking

Data Traceability

Education

Bachelor's degree in electrical engineering, Automation, Computer Engineering, Information Technology, or related field

Tools

eDHR systems

MES platforms

OPC UA

MQTT

Job description

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)