System Design & Integration
Design and implement automation control systems for BMS, EMS, and SCADA to monitor critical parameters such as temperature, humidity, differential pressure, HVAC performance, and cleanroom controls.
Configure and integrate Human-Machine Interfaces (HMIs) for operator control and monitoring of pharmaceutical processes.
Develop and maintain functional specifications, logic diagrams, wiring schematics, and network architecture for automation systems.
IT & Network Coordination
Collaborate with IT teams to define requirements for low-voltage cabling, IP address allocation, network security, and VPN access to support remote login and system integration for facilities as well as cleanroom equipment.
Coordinate with cybersecurity stakeholders and risk management to ensure compliance with data integrity and system access standards (e.g., 21 CFR Part 11, GAMP 5).
System Support & Troubleshooting
Support installation, commissioning, and qualification of automation hardware and software systems.
Troubleshoot hardware and communication issues between PLCs, HMIs, sensors, and enterprise systems.
Maintain and update automation system backups, patch management logs, and system audit trails.
Compliance & Documentation
Ensure automation systems meet GxP, FDA, cGMP, and 21 CFR Part 11 compliance standards.
Prepare and maintain validation documentation (e.g., IQ/OQ protocols), URS, FRS, and SOPs related to automation systems.
Support internal and regulatory audits by providing technical documentation and system access logs.
Interface with validation, QA, and facilities engineering teams to support ongoing system monitoring, alarms, alerts, and environmental excursion response.
Work with vendors and contractors during new system implementation or upgrades.