Principal Automation Engineer

About the position

The Principal Automation Engineer will be responsible for identifying and developing automation technologies and Manufacturing control systems to improve site productivity and quality and safety performance. The Principal Automation Engineer will be the technical lead for automation development and the site Subject Matter Expert (SME) for new and existing Manufacturing control systems.

Responsibilities

• Identify opportunities for automation improvements to Manufacturing productivity, quality, and EHS (environmental, health, and safety), including technology options, vendor identification, and project business cases.
• Develops moderate to complex control configuration or programming in accordance with design documents to meet functional requirements.
• Acts as a Subject Matter Expert (SME) for Automation Applications, leading the design and deployment of automated visual systems, aggregation, and other track and trace systems on packaging and manufacturing lines.
• Lead and support site digitalization, AI, robotics and Factory of the Future initiatives.
• Integrates vision inspection technologies (cameras, lighting, optics) with track and trace hardware (printers, scanners) to form a cohesive quality and identification system.
• Ensures seamless data flow and integration from vision and track-and-trace systems to control systems (PLCs, printers, scanners) and enterprise-level software (ERP or MES).
• Leads the development and execution of OT Systems lifecycle deliverables, including validation activities and associated documentation like System Functional and Design Specifications.
• Implements tools for OT Systems administration and maintenance, such as operating system (OS) and antivirus updates, user account management, and critical data backup.
• Establishes project management techniques to monitor, report on, and control automation projects according to size and criticality (medium to large projects). Supports capital projects when automation expertise is required.
• Conforms to EHS management system requirements and compliance obligations, promotes continuous improvement, and considers EHS aspects during the design and change process.
• Diagnoses and troubleshoots OT System hardware, software, and networking issues, replace defective components as needed. Responsible for implementing and validating OT systems upgrades and data migrations for DCS, PLC’s, SCADA, and Data Historian systems.

Requirements

• Bachelor’s degree in Mechanical Engineering, Electrical Engineering, Computer Science, or related field is required.
• Minimum 10 years experience developing and maintaining automation software and equipment and PLC systems in a manufacturing environment; AI and machine learning experience, including experience with new technology development for new product introductions.
• Direct experience with system development and validation, including development of system specifications (DS, FS, URS) and risk-based validation strategies, and validation protocol development and execution.
• Demonstrated knowledge of 21 CFR Part 11 requirements for automated systems in the pharmaceutical or medical device industries.
• Demonstrated problem solving skills and innovative thinking to develop and implement untested solutions.
• Ability to provide technical program leadership, including external vendor management and lead cross-functional team including internal and external resources.

Nice-to-haves

• Bachelor’s degree in Engineering is Highly Desired
• (10) years of experience with Automation Equipment specifically in SCADA and PLC programming in ladder logic and instructional texts is Highly Desired
• Experience with HMI graphics development and management is Highly Desired
• Experience with commissioning and qualification activities, including computerized systems validation Highly Desired
• Experience administering and/or configuring a data historian system is Highly Desired
• Direct experience with common machine vision platforms (e.g., Cognex, Keyence, Omron, etc). Solid understanding imaging principles, including lighting, optics and camera technology is Highly Desired.
• Experience with serialization and aggregation systems. Knowledge of various marking technologies, including 1D/2D barcodes, QR codes and RFID Highly Desired.
• Experience with robotics by implementing, and supporting advanced control systems, machine vision, and track-and-trace solutions Highly Desired
• Experience in pharmaceutical and biotechnology or medical device manufacturing processes, including operational best practices and regulatory expectations Highly Desired.

Benefits

• paid time off (vacation, holidays, sick)
• medical/dental/vision insurance
• 401(k)
• long-term incentive programs