Staff Automation Engineer, CSV

Johnson & Johnson•Anasco, PR

1d•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. 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 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 Staff Automation Engineer, CSV Purpose: We are seeking a highly experienced Staff Automation Engineer, CSV to serve as the technical authority for Computer System Validation (CSV) across automated manufacturing systems. This role is responsible for establishing, executing, and sustaining cGMP compliant automation system lifecycle practices in support of new product introductions, system upgrades, and operational excellence initiatives. The position combines deep automation systems knowledge with full ownership of CSV strategy, validation execution, and regulatory alignment. The successful candidate will act as a technical leader and primary interface with Quality, IT, and Regulatory partners, ensuring all automated systems meet FDA, cGMP, and data integrity requirements.

Requirements

Minimum of a Bachelor's degree in an Engineering, Automation, Robotics, Computer Science or Software Engineering fields with over 4 years’ experience working with automated controls systems in a highly automated, regulated manufacturing environment is required.
Extensive working knowledge in regulated pharmaceutical or medical device manufacturing operations
Proven track record leading multidisciplinary teams and complex automation projects
Comprehensive knowledge of CSV methodologies, GAMP 5, and system lifecycle management
Advanced proficiency across all Allen-Bradley PLC families (ControlLogix, CompactLogix, MicroLogix), Siemens (S7-300/400/1200/1500), and Beckhoff TwinCAT systems
Extensive experience creating and maintaining operator interfaces using current industrial software platforms
Knowledge in database design, reporting systems, and data collection platform management
Comprehensive understanding of Computer System Validation (CSV) methodologies and system lifecycle management
Demonstrated proficiency with Microsoft Project and project lifecycle management
Deep understanding of cGMP regulations and FDA requirements for automated systems
Experience with qualification protocols (IQ/OQ/PQ) and validation documentation
Knowledge of 21 CFR Part 11 compliance for electronic records and signatures
Change control process experience in regulated environments
Proven ability to lead technical teams and manage vendor relationships
Strong technical writing capabilities for SOP development and system documentation
Excellent communication skills for conducting design reviews and customer meetings

Nice To Haves

Experience with Ethernet/IP, Profinet, Modbus protocols, managed switches, VLANs, and wireless industrial systems
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

Serve as CSV technical lead for automated manufacturing systems, infrastructure, and services
Define and execute validation strategies for PLC, SCADA, MES-adjacent, historian, and infrastructure systems
Own the full system lifecycle from concept through decommissioning in alignment with GAMP and J&J standards
Lead risk-based validation approaches including system impact assessments, risk assessments, and mitigation strategies
Ensure complete traceability between URS, FRS, DS, IQ, OQ, PQ, and RTM documentation
Act as SME during internal and external regulatory audits supporting FDA, notified bodies, and corporate assessments
Lead the management of existing equipment and control systems across assigned manufacturing areas
Resolve complex reliability issues and conduct assessments for system modernization needs
Implement automation requirements with full accountability for scheduling, resource management, maintenance, and operational support
Conduct comprehensive regulatory compliance assessments and implement improvements to meet cGMP, FDA, and other regulatory requirements
Ensure compliance with cGMP, GxP, and FDA regulations for automated systems
Lead implementation and assessment of 21 CFR Part 11 controls including audit trails, security, data integrity, and electronic signatures
Drive adherence to change control, deviation, CAPA, and periodic review processes for validated systems
Partner with Quality to define and implement validation governance and SOPs
Perform periodic system reviews to ensure continued validated state and regulatory readiness
Design, build, and implement HMI applications using industry-standard platforms including Ignition, Wonderware, iFIX, FactoryTalk View, and FactoryTalk Optix
Create intuitive user interfaces with optimized layout design, navigation functionality, and operator-friendly screen development
Design and implement comprehensive automation systems including robotics integration, advanced PLC programming, and sophisticated control system architectures
Integrate multiple subsystems while optimizing performance and ensuring seamless operational flow
Diagnose and resolve complex technical issues involving both software and hardware components of automated equipment
Lead 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
Lead small to medium-sized multidisciplinary teams including Computer System Validation (CSV) specialists, IT professionals, and various engineering fields
Apply Microsoft Project for comprehensive project planning, resource allocation, timeline management, and budget control
Conduct 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
Develop testing protocols and preventive maintenance programs
Work effectively in fast-paced, regulated manufacturing environments
Apply strong analytical and systematic problem-solving approach
Support production operations including off-hours support