Senior Automation Engineer - Control

Johnson & Johnson Innovative Medicine•Añasco, PR

3d•Onsite

About The Position

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 jnj.com. As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. 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. Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech We are searching for the best talent for Senior Automation Engineer, Control. Purpose: Established and productive individual contributor in a scientific or technology field. Administers automation and control systems for both modernized and legacy systems, infrastructure, and services. Plans, designs, schedules, and controls automation projects in support of new product development while contributing to key performance indicator (KPI) achievement and company initiatives. Installs and maintains control systems and automation equipment, evaluates system reliability, and determines lifecycle needs including upgrades and modernization. Documents automation and control system requirements to support project resource planning, system maintenance, and operational sustainability. Conducts routine assessments to ensure regulatory compliance and identifies necessary improvements to maintain conformity with applicable regulations. Completes assigned automation deliverables while ensuring adherence to established timelines, quality standards, and validation requirements. Analyzes complex changes in project scope and provides technical input to support schedule and cost impact assessments. Communicates effectively with internal and external subject matter experts to coordinate workflows and deliver automation and control system solutions. Provides technical guidance and mentorship to junior engineers and consistently applies Johnson & Johnson’s Credo and Leadership Imperatives in day-to-day interactions.

Requirements

Bachelor’s degree in engineering is required.
Bachelors degree in Automation, Robotics, Computer Science, or equivalent is preferred.
Minimum of 2+ years of experience working with automated controls systems in regulated, highly automated manufacturing environments, preferably in pharmaceutical or medical device sectors is required.
Proficiency across all Allen-Bradley PLC families (ControlLogix, CompactLogix, MicroLogix), Siemens (S7-300/400/1200/1500), 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
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
Strong technical writing capabilities for SOP development and system documentation
Excellent communication skills for conducting design reviews and customer meetings
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

Nice To Haves

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 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.

Responsibilities

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.
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