Senior Automation Engineer Job South Naperville Area area,Illinois USA,Engineering

We are seeking an experienced Senior Automation Engineer with over 10 years of experience in pharmaceutical manufacturing, specifically in API (Active Pharmaceutical Ingredient) facilities. The ideal candidate will lead automation initiatives, execute CAPEX projects, ensure regulatory compliance, and support digital transformation across manufacturing operations. The role requires expertise in industrial automation systems, project execution, process optimization, and cross‑functional collaboration.

Key Responsibilities

Lead automation engineering activities for API manufacturing plants.
Manage end-to-end automation scope for CAPEX projects, including concept design, engineering, procurement, installation, commissioning, qualification, and handover.
Design, develop, configure, and maintain PLC, SCADA, DCS, and HMI systems.
Execute automation upgrades, modernization, and lifecycle management projects.
Prepare and review User Requirement Specifications (URS), Functional Design Specifications (FDS), Design Qualification (DQ), Factory Acceptance Test (FAT), Site Acceptance Test (SAT), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) documentation.
Coordinate with EPC contractors, automation vendors, OEMs, consultants, and internal stakeholders during project execution.
Ensure compliance with GMP, GAMP 5, 21 CFR Part 11, Annex 11, and Data Integrity requirements.
Integrate process equipment with MES, ERP, historians, and reporting systems where applicable.
Troubleshoot automation and instrumentation issues to minimize production downtime.
Lead change control, deviation investigations, CAPA implementation, and risk assessments related to automation systems.
Support process optimization initiatives to improve equipment reliability, productivity, and energy efficiency.
Develop preventive maintenance strategies for automation systems.
Provide technical leadership and mentor junior automation engineers and technicians.
Support regulatory inspections and customer audits related to automation systems.

Required Qualifications

Bachelor's degree in Instrumentation Engineering, Electrical Engineering, Electronics Engineering, Automation Engineering, or a related discipline.
10+ years of automation engineering experience in the pharmaceutical industry.
Strong experience in API manufacturing facilities.
Proven experience managing automation deliverables for CAPEX projects.
Experience in greenfield, brownfield, or plant expansion projects.
Knowledge of process automation standards and pharmaceutical validation practices.

Technical Skills

HMI development and troubleshooting
Batch process automation
Alarm management
Historian systems
MES integration
Network architecture for industrial automation
Cybersecurity fundamentals for OT environments

Preferred Experience

Automation of reactors, centrifuges, dryers, solvent recovery systems, utilities, and clean utilities in API plants.
Experience with serialization, digitalization, or Industry 4.0 initiatives.
Exposure to IIoT, cloud connectivity, predictive maintenance, and analytics platforms.
Experience with energy management and utility automation.
Vendor management and contract execution.
Budget planning and cost control for automation projects.

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