Automation Engineer – MES & Industrial Systems Integration

Inteldot is seeking an experienced Automation Engineer to design, implement, validate, and maintain integrations between MES, shop-floor automation systems, industrial systems, and plant IT/OT services in a regulated pharmaceutical manufacturing environment. The role supports compliant data exchange, system commissioning and qualification, troubleshooting, and ongoing operations.

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

Requirements:

• 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
• 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