Automation Engineer

Responsibilities

• Support the design, configuration, and troubleshooting of automated control systems (PLCs, SCADA, DCS, HMIs) used in manufacturing processes
• Monitor automated equipment and control systems to ensure consistent operation, uptime, and product quality
• Assist in root cause analysis and corrective actions for automation-related deviations, downtime, and equipment malfunctions
• Support commissioning, qualification, and validation (IQ/OQ/PQ) of new and modified automated systems in partnership with Validation and Quality teams
• Assist in developing and updating control system documentation, including functional specifications, P&IDs, and change control records
• Collaborate with Manufacturing, Process Engineering, and Maintenance to implement automation improvements and process control optimization
• Support integration of automated systems with Manufacturing Execution Systems (MES), historians, and other plant IT/OT infrastructure
• Participate in Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT) for new automation equipment and systems
• Ensure automated systems and associated documentation comply with FDA regulations, cGMP, 21 CFR Part 11, and internal quality standards
• Support change control processes for automation system modifications, software updates, and equipment upgrades
• Assist with data historian configuration, alarm management, and control system security/access administration
• Participate in safety reviews and ensure automated systems adhere to EHS standards specific to pharmaceutical manufacturing
• Maintain accurate, audit-ready documentation for automation changes, validations, and system configurations

Qualifications

Required:

• Bachelor's degree in Engineering (Electrical, Mechanical, Chemical, Controls/Automation, Computer Engineering, or related field)
• 0–2 years of relevant experience (internships, co-ops, or entry-level automation/controls roles count)
• Basic understanding of PLC programming (e.g., Allen-Bradley/Rockwell, Siemens) and SCADA/HMI systems
• Familiarity with cGMP, FDA regulations, and pharmaceutical manufacturing environments
• Basic understanding of process validation concepts (IQ/OQ/PQ) and change control documentation
• Proficiency with MS Office (Excel, Word, PowerPoint); familiarity with control system software (RSLogix, FactoryTalk, WinCC, or similar) a plus
• Strong written and verbal communication skills, with the ability to author clear technical documentation
• Ability to work effectively in a cross-functional, highly regulated team environment
• Willingness to work on the production floor, including gowning/cleanroom protocols as required