Staff Automation Engineer, CSV

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About Vision

Fueled by innovation at the intersection of biology and technology were 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 thats 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 patients lifetime.
Your unique talents will help patients on their journey to wellness. Learn more at 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.

You will be responsible for:

CSV & System Lifecycle Leadership

• 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

Systems Management & Automation Leadership

• 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

GMP / GxP Compliance & Regulatory Readiness

• 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

HMI/SCADA Development & Control Systems

• 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

Technical Problem Resolution & System Integration

• 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

Project Leadership & multi-functional Collaboration

• 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

Qualifications / Requirements:

Experience & Education

• Minimum of a Bachelors 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

Core Technical Expertise

• 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

Regulatory & Compliance Knowledge

• 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

Leadership & Communication Skills

• 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

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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