The Role
Designs, implements, validates, troubleshoots, and maintains integrations among MES, PLC, DCS, SCADA, data historians, and plant IT/OT systems in regulated pharmaceutical manufacturing. Develops ISA-95 architecture and interface specifications, supports EBR and OEE solutions, prepares computerized system validation documentation, ensures regulatory compliance, and provides technical support during implementation, commissioning, qualification, and ongoing operations.
Summary Generated by Built In
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.
- 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.
Skills Required
- 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
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The Company
What We Do
Inteldot offers custom turn-key systems, systems integration, MES eBR configuration and integration solutions, business intelligence and analytics and technical staffing. We have been providing the Pharmaceutical, Manufacturing and Medical Device industries with services for a variety of applications since 2004
