Automation Engineer – MES & Industrial Systems Integration

Inteldot; Carolina (PR); On-site; USD 95,000 - 135,000; Full time

Job summary

Inteldot is seeking an experienced Automation Engineer to support the design, validation, and maintenance of MES integrations with shop-floor automation systems and plant IT/OT services within a regulated pharmaceutical manufacturing environment.

The role requires hands-on automation experience, MES integration, communication protocols, and computerized system validation to ensure reliable, compliant data exchange across manufacturing systems.

Qualifications

• Hands-on experience with industrial automation engineering.
• Experience with MES and industrial automation systems (PLC, DCS, SCADA).
• Knowledge of industrial communication protocols and integration architectures.
• Experience developing technical specifications and interface documentation.
• Understanding of computerized system validation (IQ/OQ/PQ) practices.

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 (PLC, DCS, SCADA).
• Support integration solutions for EBR, OEE, data historians, and manufacturing analytics.
• Troubleshoot and maintain interfaces to ensure reliable data exchange and system performance.
• Develop and execute validated documentation including URS, TMX, DSP, IQ/OQ/PQ protocols.
• Ensure compliance with regulatory requirements, site procedures, and industry standards.
• Develop SOPs, technical documentation, and training materials as needed.

Skills

MES integration

Industrial automation

Communication protocols

Documentation skills

Troubleshooting

Education

Bachelor's degree in Engineering

Tools

ISA-95 architecture

Job description

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.