Senior Automation Engineer, Electrical Machine Safety

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at ;br>
Job Function:
Supply Chain Engineering

Job Sub Function:
Automation Engineering

Job Category:
Scientific/Technology

All Job Posting Locations:
Anasco, Puerto Rico, United States of America

Job Description:
About Vision

Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments.

Are you passionate about improving and expanding on the possibilities of vision treatments? Ready to join a team that's reimagining how vision is improved? Our Vision team solves the toughest health challenges. Help combine cutting-edge insights, science, technology, and people to encourage eye care professionals and patients to proactively protect, correct and enhance healthy sight for life. Our products and services address these needs - from the pediatric to aging eye - in a patient's lifetime.
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We are searching for the best talent for Senior Automation Engineer, Electrical Machine Safety.

Purpose: We are seeking an experienced automation professional to establish and implement comprehensive automation solutions for our manufacturing systems, infrastructure, and services. This role involves planning, designing, and managing automation projects that support new product development while ensuring compliance with regulatory standards and operational excellence. The successful candidate will serve as a technical subject matter expert, driving automation strategies, managing sophisticated projects, and enhancing electrical machine safety programs.

You will be responsible for:

Systems Management

• Develop and oversee automated control systems including PLC, Safety PLC, robotics, electrical, servo motion, vision, SCADA, and complex device integration, applying industry standards such as IEC 61131, IEC 61508 (Functional Safety), and ISO 12100 (Machine Safety).
• Serve as a consultant and technical SME, supporting colleagues and cross-functional teams in automation design, troubleshooting, and system modernization.
• Manage significant automated equipment procurement, installation, validation, and qualification, working closely with project managers and internal teams.
• Provide technical guidance on electrical machine safety, ensuring compliance with global standards such as IEC 61508, IEC 62061, and ISO 13849-1.
• Conduct risk assessments, safety system design reviews, and validation activities for automation solutions.

Control Systems Development & Validation

• Design and implement high-quality PLC and SCADA solutions from functional and detailed design specifications, supporting all phases of lifecycle including validation in validated manufacturing environments compliant with cGMP, FDA, and 21 CFR Part 11.
• Develop and validate automated control solutions for legacy and new equipment, ensuring safe, reliable, and scalable operation.
• Support and lead validations (IQ/OQ/PQ) to ensure control systems meet regulatory, safety, and quality requirements.

Technical Problem Resolution & System Integration

• Diagnose and resolve complex technical issues involving both software and hardware components of automated equipment
• Participate in solving efforts for critical production systems and implement preventive maintenance strategies
• Provide on-call support for production operations as needed
• Handle system integrations across diverse platforms including Beckhoff, Allen-Bradley, Siemens, Wonderware, and data historian systems

Data Management & Analytics Systems

• Configure and maintain databases, reporting systems, and comprehensive data collection platforms
• Implement and optimize Data Historian for data storage, retrieval, trending, and advanced analytics
• Generate and maintain preventive maintenance schedules and procedures to ensure optimal machine functionality

Multi-functional Collaboration

• Apply Microsoft Project for comprehensive project planning, resource allocation and timeline management
• Participate in technical design reviews and vendor management meetings with equipment suppliers and service providers
• Prepare detailed Standard Operating Procedures (SOPs), work instructions, and user documentation
• Manage Computer System Validation (CSV) processes and system lifecycle documentation throughout project phases

Qualifications / Requirements:

Experience & Education

• Bachelor's Degree in Engineering, Automation, Robotics, Computer Science, or equivalent.
• Minimum of 2 years of experience working with automated controls systems in regulated, highly automated manufacturing environments, preferably in pharmaceutical or medical device sectors.
• Experience in electrical machine safety (IEC 61508, ISO 13849, IEC 62061).

Core Technical Expertise

• Proficiency across all Allen-Bradley PLC families (ControlLogix, CompactLogix, MicroLogix), Siemens (S7-/1500), and Beckhoff TwinCAT systems
• Experience creating and maintaining operator interfaces using current industrial software platforms
• Knowledge in database design, reporting systems, and data collection platform management
• Understanding of Computer System Validation (CSV) methodologies and system lifecycle management

Regulatory & Compliance Knowledge

• Deep understanding of cGMP regulations and FDA requirements for automated systems
• Experience with qualification protocols (IQ/OQ/PQ) and validation documentation
• Understanding of ISO 13485, ISO 9001, IEC 61508, IEC 61511, ISO 12100, and 21 CFR Part 11 regulatory standards.
• Knowledge of 21 CFR Part 11 compliance for electronic records and signatures
• Change control process experience in regulated environments

Communication Skills

• Strong technical writing capabilities for SOP development and system documentation
• Excellent communication skills for conducting design reviews and customer meetings

Additional Requirements

• Experience developing testing protocols and preventive maintenance programs
• Ability to work effectively in fast-paced, regulated manufacturing environments
• Strong analytical and systematic problem-solving approach
• Flexibility to support production operations including off-hours support

Preferred Qualifications

Advanced Technical Skills

• Industrial Networking: Experience with Ethernet/IP, Profinet, Modbus protocols, managed switches, VLANs, and wireless industrial systems
• Network Troubleshooting: Knowledge with diagnostic and connectivity issue resolution

Professional Certifications

• Professional Engineering (PE) license
• Beckhoff, Rockwell Automation or Siemens automation platform certifications

Emerging Technologies

• Experience with Industry 4.0 initiatives and digital transformation projects
• Cloud-based automation solutions and data analytics platforms
• Advanced process analytics and machine learning applications
• Experience with backup systems, redundancy configurations, and disaster recovery planning
• Knowledge integrating Artificial Intelligence in manufacturing processes to enhance manual operations and improve efficiency.

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law.

We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center () or contact AskGS to be directed to your accommodation resource.

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