Automation Engineer – MES & Industrial Systems Integration

Position Summary

Inteldot is seeking an experienced Automation Engineer to support the design, implementation, validation, and maintenance of integrations between Manufacturing Execution Systems (MES), shop-floor automation systems (PLC/DCS/SCADA), industrial systems, data historians, and plant IT/OT services within a regulated pharmaceutical manufacturing environment.

The ideal candidate will have hands-on experience with industrial automation, MES integration, communication protocols, and computerized system validation, ensuring reliable and compliant data exchange across manufacturing systems.

Key Responsibilities

• Design and implement integration strategies between MES, industrial automation systems, and plant IT/OT infrastructure.
• Collaborate with equipment manufacturers, engineering teams, vendors, and key stakeholders to define integration requirements and technical solutions.
• Develop and maintain Interface Design Specifications (IDS) and ISA-95 architecture documentation.
• Configure and support communication interfaces between MES and automation systems, including PLC, DCS, and SCADA platforms.
• Support integration solutions for Electronic Batch Records (EBR), Overall Equipment Effectiveness (OEE), process monitoring, data historians, and manufacturing analytics.
• Troubleshoot and maintain communication interfaces to ensure reliable data exchange and system performance.
• Develop and execute computerized system validation documentation, including User Requirements Specifications (URS), Traceability Matrices (TMX), Design Specifications (DSP), and IQ/OQ/PQ protocols.
• Ensure automation and MES integration solutions comply with applicable regulatory requirements, site procedures, and industry standards.
• Develop Standard Operating Procedures (SOPs), technical documentation, and training materials as needed.
• Provide technical support during implementation, commissioning, qualification, and ongoing system operations.

Required Qualifications

• Bachelor's degree in Engineering, Automation, Electrical Engineering, Computer Engineering, or a related technical discipline.
• Experience in industrial automation engineering, manufacturing systems integration, or a related technical role.
• Hands-on experience with MES and industrial automation systems, including PLC, DCS, or SCADA.
• Knowledge of industrial communication protocols and integration architectures.
• Experience developing technical specifications and interface documentation.
• Understanding of computerized system validation practices, including IQ/OQ/PQ and requirements traceability.
• Strong troubleshooting, analytical, and problem-solving skills.
• Ability to collaborate with cross-functional engineering, manufacturing, quality, and IT/OT teams.
• Strong technical documentation and communication skills.

Preferred Qualifications

• Previous experience in pharmaceutical, biotechnology, or other FDA-regulated manufacturing environments.
• Familiarity with ISA-95 standards and manufacturing systems architecture.
• Experience with EBR, OEE, data historians, and industrial data analytics solutions.
• Knowledge of GAMP 5, GxP requirements, and applicable data integrity principles.
• Experience supporting MES implementations, system upgrades, or automation integration projects.