Automation Engineer

Title: Automation Engineer

Location: NC

Summary:

We are looking for a skilled Automation Engineer with strong PLC expertise to support and enhance automation systems in a regulated pharmaceutical manufacturing environment. The ideal candidate will play a key role in ensuring system reliability, compliance, and efficiency across production lines.

Responsibilities:

• Design, develop, and maintain PLC-based automation systems for pharmaceutical manufacturing processes
• Troubleshoot and resolve issues related to PLC, SCADA, and HMI systems
• Perform system upgrades, modifications, and validations in compliance with GMP standards
• Develop and maintain documentation including FDS, HDS, SDS, and validation protocols (IQ/OQ/PQ)
• Collaborate with cross-functional teams (Production, QA, Maintenance) to ensure smooth operations
• Support audits and ensure adherence to regulatory requirements (FDA, MHRA, etc.)
• Monitor system performance and recommend continuous improvement initiatives

Requirements:

• Bachelor’s degree in Electrical / Instrumentation / Automation Engineering or related field
• Hands-on experience with PLC systems (e.g., Siemens, Allen-Bradley, Schneider)
• Experience with SCADA/HMI systems (e.g., WinCC, FactoryTalk, Wonderware)
• Strong understanding of GMP, 21 CFR Part 11, and validation processes
• Knowledge of industrial communication protocols (Modbus, Profibus, Ethernet/IP)
• Good troubleshooting and analytical skills
• Experience in pharmaceutical or regulated manufacturing environments
• Exposure to DCS systems and MES integration
• Familiarity with CSV (Computer System Validation)