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
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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 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 QualificationsAdvanced 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.
#LI-Onsite
Required Skills: Preferred Skills: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
