Senior Automation Engineer - Control

About the role

Established and productive individual contributor in a scientific or technology field. Administers automation and control systems for both modernized and legacy systems, infrastructure, and services. Plans, designs, schedules, and controls automation projects in support of new product development while contributing to key performance indicator (KPI) achievement and company initiatives.

Responsibilities

• Develop and oversee automated control systems including PLC, Safety PLC, robotics, electrical, servo motion, vision, SCADA, and complex device integration, applying industry standards such as IEC 61131, IEC 61508 (Functional Safety), and ISO 12100 (Machine Safety).
• Serve as a consultant and technical SME, supporting colleagues and cross-functional teams in automation design, troubleshooting, and system modernization.
• Manage significant automated equipment procurement, installation, validation, and qualification, working closely with project managers and internal teams.
• Conduct risk assessments, safety system design reviews, and validation activities for automation solutions.
• Analyze complex changes in project scope and provide technical input to support schedule and cost impact assessments.
• Communicate effectively with internal and external subject matter experts to coordinate workflows and deliver automation and control system solutions.
• Provide technical guidance and mentorship to junior engineers and consistently apply Johnson & Johnson’s Credo and Leadership Imperatives in day-to-day interactions.
• Systems Management: Develop and oversee automated control systems including PLC, Safety PLC, robotics, electrical, servo motion, vision, SCADA, and complex device integration, applying industry standards such as IEC 61131, IEC 61508 (Functional Safety), and ISO 12100 (Machine Safety).
• Control Systems Development & Validation: Design and implement high-quality PLC and SCADA solutions from functional and detailed design specifications, supporting all phases of lifecycle including validation in validated manufacturing environments compliant with cGMP, FDA, and 21 CFR Part 11.
• Data Management & Analytics: Configure and maintain databases, reporting systems, and comprehensive data collection platforms. Implement and optimize Data Historian for data storage, retrieval, trending, and advanced analytics. Generate and maintain preventive maintenance schedules and procedures to ensure optimal machine functionality.
• Technical Problem Resolution & System Integration: Diagnose and resolve complex technical issues involving both software and hardware components of automated equipment. Participate in 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.
• Multi-functional Collaboration: Apply Microsoft Project for comprehensive project planning, resource allocation and timeline management. Participate in 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

• Bachelor’s degree in engineering is required. Bachelors degree in Automation, Robotics, Computer Science, or equivalent is preferred.
• Minimum of 2+ years of experience working with automated controls systems in regulated, highly automated manufacturing environments, preferably in pharmaceutical or medical device sectors is required.
• Core Technical Expertise: Proficiency across all Allen-Bradley PLC families (ControlLogix, CompactLogix, MicroLogix), Siemens (S7-300/400/1200/1500), and Beckhoff TwinCAT systems. Experience creating and maintaining operator interfaces using current industrial software platforms. Knowledge in database design, reporting systems, and data collection platform management. Understanding of Computer System Validation (CSV) methodologies and system 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. Understanding of ISO 13485, ISO 9001, IEC 61508, IEC 61511, ISO 12100, and 21 CFR Part 11 regulatory standards. Knowledge of 21 CFR Part 11 compliance for electronic records and signatures. Change control process experience in regulated environments.
• Communication Skills: 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.

Qualifications

• Experience & Education: Bachelor’s degree in engineering is required. Bachelors degree in Automation, Robotics, Computer Science, or equivalent is preferred. Minimum of 2+ years of experience working with automated controls systems in regulated, highly automated manufacturing environments, preferably in pharmaceutical or medical device sectors is required.
• Core Technical Expertise: Proficiency across all Allen-Bradley PLC families (ControlLogix, CompactLogix, MicroLogix), Siemens (S7-300/400/1200/1500), and Beckhoff TwinCAT systems. Experience creating and maintaining operator interfaces using current industrial software platforms. Knowledge in database design, reporting systems, and data collection platform management. Understanding of Computer System Validation (CSV) methodologies and system 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. Understanding of ISO 13485, ISO 9001, IEC 61508, IEC 61511, ISO 12100, and 21 CFR Part 11 regulatory standards. Knowledge of 21 CFR Part 11 compliance for electronic records and signatures. Change control process experience in regulated environments.
• Communication Skills: 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.