Senior Automation Engineer

Responsibilities

• Lead design, configuration, and troubleshooting of automated control systems (PLCs, SCADA, DCS, HMIs) across manufacturing operations
• Own control system lifecycle activities, including specification, commissioning, qualification, and long-term support of automation platforms
• Lead validation and qualification (IQ/OQ/PQ) of new and modified automated systems in partnership with Validation and Quality teams
• Serve as automation subject matter expert (SME) during internal audits and external regulatory inspections (FDA, ISO), including front room/back room support
• Author and approve functional specifications, control narratives, P&IDs, and system architecture documentation for automation projects
• Lead integration efforts between automated systems, Manufacturing Execution Systems (MES), data historians, and broader plant IT/OT infrastructure
• Lead Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT) planning and execution for new automation equipment and control systems
• Drive change control processes for automation modifications, software upgrades, and system migrations, ensuring appropriate risk assessment and revalidation scope
• Lead root cause investigations for automation-related deviations, downtime events, and control system failures
• Mentor and provide technical guidance to junior automation engineers on control system design, programming standards, and troubleshooting
• Partner with Manufacturing, Process Engineering, Validation, and IT/OT teams to align automation project timelines with production and capital project schedules
• Drive continuous improvement initiatives to enhance system reliability, cybersecurity posture, and process control optimization
• Manage vendor and contractor relationships for automation system integrators, ensuring quality and timeline adherence on capital projects
• Ensure all automation systems and documentation comply with FDA regulations, cGMP, 21 CFR Part 11, and internal quality standards
• Support alarm management strategy, data historian configuration, and control system security/access administration at a program level

Qualifications

Required:

• Bachelor's degree in Engineering (Electrical, Mechanical, Chemical, Controls/Automation, Computer Engineering, or related field)
• 5+ years of automation/controls engineering experience in pharmaceutical, biotech, or medical device manufacturing
• Strong hands-on experience with PLC programming (e.g., Allen-Bradley/Rockwell, Siemens) and SCADA/HMI system design
• Demonstrated experience leading commissioning, qualification, and validation of automated systems (IQ/OQ/PQ)
• Strong working knowledge of cGMP, FDA regulations, and 21 CFR Part 11 as applied to automated/computerized systems
• Experience supporting or leading FDA/regulatory inspections as an automation SME
• Proficiency with control system software (RSLogix, FactoryTalk, WinCC, or similar) and industrial networking fundamentals
• Excellent written and verbal communication skills, with ability to influence cross-functional stakeholders and present to leadership
• Proven ability to manage multiple automation projects simultaneously, including budgets, timelines, and vendor coordination
• Willingness to work on the production floor, including gowning/cleanroom protocols as required