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.

Job Summary

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.

Responsibilities

• 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.

Minimum Qualifications

• 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 experience in team supervision and/or engineering project management.
• Experience managing automation, capital equipment, or manufacturing engineering projects.
• Experience with process and equipment validation within regulated manufacturing environments.
• Experience supporting CAPA, root cause analysis, PFMEA, and manufacturing risk-management activities.
• Knowledge of FDA, GMP, ISO 13485, and applicable quality-system requirements.
• Experience with Lean Manufacturing and continuous improvement tools.
• Advanced English proficiency required.
• Availability to travel as required.

Functional Competencies

• Strong technical and team leadership.
• Advanced analytical thinking and problem-solving capabilities.
• Risk-based decision-making.
• Strong project management and organizational skills.
• Effective written and verbal communication.
• Strong quality and regulatory compliance mindset.
• Ability to lead cross-functional technical initiatives.
• Change management and continuous improvement.
• Ability to manage multiple complex engineering priorities simultaneously.

What is expected of you and others at this level

• Applies comprehensive technical knowledge and advanced understanding of automation and manufacturing engineering principles.
• Independently leads complex engineering projects of significant scope and business impact.
• Develops innovative technical solutions to difficult and complex manufacturing challenges.
• Serves as a technical authority and trusted engineering resource within the organization.
• Provides technical direction and guidance to engineers, technicians, vendors, and cross-functional partners.
• Exercises sound technical judgment and risk-based decision-making.
• Influences technical standards, engineering practices, and continuous improvement strategies.
• Works independently while effectively collaborating with local and global teams.
• Ensures engineering solutions support operational excellence, product quality, regulatory compliance, and business objectives.

Candidates who are back-to-work, people with disabilities, without a college degree, and Veterans are encouraged to apply.

Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day. Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law.

To read and review this privacy notice click here