Staff Automation Engineer, CSV
Antler
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Job summary
Johnson & Johnson is seeking a Staff Automation Engineer, CSV to act as the technical authority for CSV across automated manufacturing systems. This role drives cGMP lifecycle practices, validation execution, and regulatory alignment in support of new product introductions, upgrades, and continuous improvement.
The successful candidate will lead cross-functional teams, coordinate with Quality, IT, and Regulatory partners, and ensure compliance with FDA, 21 CFR Part 11, and data integrity
Qualifications
- Bachelor's degree in Engineering or related field.
- Experience with CSV methodologies in regulated environments.
- Familiarity with GMP/FDA requirements and 21 CFR Part 11.
Responsibilities
- Lead CSV strategies and validation activities for automated manufacturing systems.
- Ensure traceability across URS, IQ/OQ/PQ, and validation deliverables.
- Partner with Quality, IT, and Regulatory to meet FDA and data integrity standards.
- Oversee risk-based validation, audits, and regulatory readiness.
- Provide technical leadership across CSV and system lifecycle activities.
Skills
Education
Tools
Job description
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.
Supply Chain Engineering
Automation Engineering
Scientific/Technology
Anasco, Puerto Rico, United States of America
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
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.
- 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
- 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.
- GMP Environment Experience: Extensive working knowledge in regulated pharmaceutical or medical device manufacturing operations
- Team Leadership: 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
- 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
- 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.
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 (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource.
Artificial Intelligence (AI), Controls Compliance, Critical Thinking, Industrial Robotics, Industry Analysis, Innovation, Lean Supply Chain Management, Machine Learning (ML), Management Systems Implementation, Organizing, Problem Solving, Project Management, Prototyping, Robotic Automation, Science, Technology, Engineering, and Math (STEM) Application, Smart Systems, Technologically Savvy
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