Transformation Project Automation Lead, API

What you'll do

• Identify automation opportunities to improve manufacturing productivity, quality, and EHS performance.
• Develop project business cases and identify technology options and vendors for automation improvements.
• Lead the design of automation equipment and control systems, including system requirements and laboratory testing.
• Manage external vendors and oversee the qualification and integration of new automation systems.
• Serve as the Subject Matter Expert for automation technologies to ensure Design for Manufacturability.
• Manage the full lifecycle of new and existing on-site control systems.
• Provide technical support and troubleshooting for all manufacturing control system issues.
• Drive the schedule, execution, risk management, and reporting for the project automation sub-team.

What we're looking for

• Bachelor’s degree in Mechanical Engineering, Electrical Engineering, Computer Science, or a related field.
• Minimum 10 years of experience developing and maintaining automation software, equipment, and PLC systems in a manufacturing environment.
• Experience with AI and machine learning, including new technology development for new product introductions.
• Direct experience with system development and validation, including system specifications (DS, FS, URS) and risk-based validation strategies.
• Demonstrated knowledge of 21 CFR Part 11 requirements for automated systems in 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 leading cross-functional teams.