Senior Automation Engineer - Control

Johnson & Johnson Innovative Medicine • Añasco, PR

6d • Onsite

About The Position

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.
• 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

• Bachelors degree in Automation, Robotics, Computer Science, or equivalent is preferred.
• 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.
• 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

• 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.
• 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.
• 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.
• 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.
• 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.

Benefits

• 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 ([email protected]) or contact AskGS to be directed to your accommodation resource.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior