Ingeniero Principal de Automatización

What Engineering Program/Project Management contributes to Cardinal Health   Engineering is responsible for performing research, analysis, design, implementation, and continuous improvement activities for products, systems, manufacturing equipment, and processes. Manufacturing Engineering develops and implements manufacturing technologies, automation systems, equipment, production processes, and associated tools to improve product quality, process capability, operational efficiency, reliability, safety, and cost performance.

The Principal Automation Engineer provides technical leadership for the design, implementation, documentation, validation, and continuous improvement of automation systems used within manufacturing operations. This position serves as a Subject Matter Expert (SME) for industrial automation and capital engineering projects and is responsible for ensuring automation solutions comply with applicable regulatory requirements, including FDA, GMP, and ISO 13485 standards, while maintaining data integrity, product quality, operational performance, and patient safety. The Principal Automation Engineer manages automation initiatives including CAPEX, OPEX, and sustaining projects and provides technical leadership to engineering teams throughout the complete project lifecycle.

Defines automation architecture aligned with regulatory standards, manufacturing requirements, and business strategy. Leads the design, development, implementation, and continuous improvement of industrial automation systems. Manages the automation project portfolio, including CAPEX, OPEX, and sustaining initiatives, ensuring scope, budget, schedule, and technical objectives are achieved. Serves as a Subject Matter Expert (SME) for automation technologies and capital project management. Provides technical leadership, mentoring, and guidance to automation engineers and other technical personnel. Establishes and maintains technical standards, engineering methodologies, libraries, specifications, and automation best practices. Designs and implements automation solutions that meet product, quality, regulatory, safety, and operational requirements. Evaluates existing manufacturing equipment and automation systems and identifies opportunities for reliability, productivity, quality, and cost improvements. Leads troubleshooting and root cause analysis of complex automation, equipment, and manufacturing process issues. Provides technical support for CAPA investigations and implements effective engineering solutions to prevent recurrence. Supports the development and maintenance of PFMEA documentation to identify and mitigate manufacturing and process risks. Participates in process and automation system validation activities, including FAT, SAT, IQ, and other applicable qualification activities. Provides automation engineering support for New Product Introduction (NPI), ensuring automation requirements are integrated during early project stages. Serves as a technical representative during internal and external regulatory audits, including FDA, ISO, customer, and quality-system audits. Collaborates cross-functionally with Manufacturing, Quality, Operations, Maintenance, Regulatory, IT/OT, and other Engineering teams. Supports equipment commissioning, qualification, implementation, and production startup activities. Ensures automation projects comply with applicable regulatory, quality, safety, environmental, and Cardinal Health requirements. Identifies opportunities to apply new automation technologies and engineering solutions to improve manufacturing performance.

Bachelor’s degree in Electromechanical Engineering, Mechatronics Engineering, Electronic Engineering, Automation Engineering, or a related technical discipline. 5+ years of experience in industrial automation. 5+ years of experience within the medical device, pharmaceutical, or another highly regulated industry. 3+ years of