Senior Automation Engineer

Job Title: Senior 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