Job Description Summary

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

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Primary Work Location

Additional Locations

Work Shift