Staff Automation Engineer, CSV

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

Job Description:

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.

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 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

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 maint