Operational Technology Engineer

Becton Dickinson; Kulim; On-site; MYR 70,000 - 100,000; Full time

Job summary

A global medical technology company located in Kulim, Malaysia, is seeking a skilled professional to enhance system integration of operational technology and eDHR systems. The ideal candidate will have a Bachelor's degree in engineering and 3-6 years of experience in manufacturing IT or industrial automation. Responsibilities include ensuring data accuracy, securing OT systems, and collaborating with quality teams for regulatory compliance. Knowledge of MES platforms and cybersecurity practices is highly desirable. Competitive compensation is provided.

Qualifications

• Bachelor’s degree in electrical engineering or related field required.
• 3–6 years of experience in operational technology or manufacturing IT.
• Experience in industries like medical devices or pharmaceuticals preferred.

Responsibilities

• Connect shop-floor equipment with eDHR systems.
• Ensure real-time data capture from manufacturing processes.
• Implement cybersecurity measures to protect OT systems.

Skills

Operational technology expertise

Industrial automation experience

Regulatory industry experience

eDHR system integration

Network infrastructure knowledge

Cybersecurity awareness

Data traceability knowledge

Health monitoring skills

Education

Bachelor’s degree in electrical engineering, automation, computer engineering, information technology

Tools

eDHR systems

MES platforms (preferably Apriso)

Job description

Responsibilities

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.

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.