Manufacturing Automation Engineer

Job Title:
Manufacturing Automation Engineer
Location:
Kentucky (Onsite)

Experience:
8+ years

Duration:
12+ Month Contract (Extension based on project needs)

Role Overview
The Senior Automation Engineer will support pharmaceutical manufacturing operations by designing, implementing, and maintaining automated systems in a regulated cGMP environment. This role works closely with Manufacturing, Quality, Maintenance, and Validation teams to improve system reliability, efficiency, and compliance.

Key Responsibilities

• Design, develop, and implement automation solutions including software, hardware, and integrated processes
• Analyze existing manufacturing and packaging systems to identify automation opportunities and improvements
• Configure, manage, and support site-level automation systems such as serialization, data historians, reporting systems, and industrial networks
• Lead automation scope for new process and utility equipment, including design, procurement, installation, start-up, commissioning, and qualification
• Author, review, and execute IQ, OQ, and PQ protocols and generate summary reports
• Support automation standardization initiatives and site technology master planning
• Develop scripts and code to automate workflows, data collection, and system tasks
• Test, troubleshoot, and optimize automated systems to ensure reliability and performance
• Diagnose automation issues, implement corrective actions, and support continuous improvement efforts
• Support manufacturing equipment used for producing and packaging nasal spray drug products
• Perform troubleshooting and maintenance support for PLCs, HMIs, networks, and industrial automation systems
• Review and approve preventive maintenance activities, calibration strategies, tolerances, and automation-related PMs
• Support backup, restore, and disaster recovery activities for automation systems
• Participate in deviation investigations, change controls, and CAPAs as part of cross-functional teams
• Collaborate with engineering, validation, quality, and maintenance teams to ensure project success
• Provide clear technical documentation and communicate effectively with stakeholders
• Support plant engineering, maintenance, and calibration activities as required

Required Qualifications

• Bachelor's degree in Engineering or related field, or equivalent practical experience

• Minimum 8 years of relevant experience

• Or 6 years with a Master's degree

• Or 3 years with a PhD

• Strong experience in Automation Engineering within industrial or regulated environments

• Solid understanding of industrial automation networking and historian systems
• Hands-on experience with PLCs, HMIs, industrial sensors, and control systems
• Controls system design experience
• General electrical design knowledge
• Working knowledge of cGMP and GAMP 5 regulations
• Experience with technical documentation including SOPs, PMs, URSs, and vendor RFPs

Preferred Qualifications

• Experience in pharmaceutical or life sciences manufacturing environments
• Experience with nasal spray products or drug delivery devices
• Strong background in industrial networking and server management
• Experience with site-level automation platforms such as:
• Serialization systems (Antares, TraceLink)
• Data Historians (AVEVA OSI PI)
• Reporting tools (OSI PI, MS Report Builder, SQL)
• OPC and connectivity tools (Kepware, Matrikon)
• Automation platforms (Allen-Bradley FactoryTalk)
• Automated visual inspection systems