LEAD AUTOMATION ENGINEER (475)

Job Responsibilities

• Act as the client-side technical authority for the EMS implementation, ensuring the design meets process, facility, and GxP requirements.
• Review and approve SI deliverables, including functional/design specifications, Ignition HMI screens, and Allen Bradley PLC/PlantPAx configuration.
• Ensure Ignition HMI screens are developed to high-performance HMI standards (e.g., ISA-101) for effective operator interaction and alarm management.
• Oversee the development and standardization of Allen Bradley Add-On Instructions (AOIs) to ensure consistency, reusability, and long-term maintainability.
• Oversee all vendor design work and PLC programming, including Ignition application development and Allen Bradley/PlantPAx code, ensuring adherence to site and global standards.
• Conduct formal code reviews of vendor-developed PLC logic, AOIs, and HMI applications prior to FAT/SAT, identifying and driving resolution of design, quality, and standards gaps.
• Manage the SI relationship end-to-end — scope, schedule, budget, and quality of deliverables — through design, development, factory acceptance testing (FAT), and on-site deployment/commissioning (SAT).
• Hold the SI accountable to project milestones, technical specifications, and compliance requirements.
• Cook up FAT/SAT execution and IQ/OQ/PQ support activities, and drive punch-list and issue resolution to closure.
• Serve as the primary escalation point for technical issues between the SI, plant operations, engineering, and quality organizations.
• Partner with global automation and engineering teams to convert the Kansas EMS implementation into a reusable, standardized template for deployment at other sites.

Job Requirements

• Bachelor's degree in Electrical, Controls, Chemical, or a related Engineering discipline, or equivalent professional experience.
• Significant automation engineering experience on capital projects within regulated life sciences (pharmaceutical/biotech) manufacturing environments.
• Hands-on experience with the Ignition SCADA/HMI platform, including high-performance HMI/graphics design.
• Strong Allen Bradley PLC programming experience, including development and standardization of Add-On Instructions (AOIs).
• Experience with Rockwell PlantPAx DCS architecture and configuration.
• Direct experience with Environmental Monitoring Systems (EMS) in GMP-regulated facilities.
• Demonstrated experience managing System Integrators on capital automation projects, including scope, schedule, deliverable quality, and FAT/SAT.
• Experience across both drug substance (API/bulk) and drug product (fill-finish/packaging) manufacturing environments.
• Solid working knowledge of SDLC methodology under GAMP 5, computer system validation (CSV/CSA), and 21 CFR Part 11/data integrity requirements — including hands-on experience conducting code reviews within a validated SDLC framework.