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.