Automation Lead

Job Summary

The Automation Area Lead will provide technical leadership for a defined process area within a pharmaceutical capital project at a regulated manufacturing site in Bradley, IL (Onsite).

Roles & Responsibilities

• Provide technical oversight of automation system design and architecture across Siemens DCS, OpCenter MES, and interfaces to packaging and enterprise systems (Level 3/4)
• Ensure compliance with ISA-88 batch control principles, GAMP 5 guidelines, and GxP regulatory requirements
• Lead and participate in design reviews, including User Requirement Specifications (URS), Functional Specifications, and Design Specifications
• Promote modular design, standardization, and scalable automation architectures
• Drive automation risk management activities, including GxP assessments and system risk assessments
• Collaborate with engineering, manufacturing, quality, and validation teams to ensure successful project delivery
• Identify technical risks and implement mitigation strategies, supporting issue resolution throughout the project lifecycle
• Ensure alignment of automation systems with project standards and operational objectives

Education & Experience

• Strong experience in pharmaceutical or biotech automation and process control systems
• Hands-on experience with Siemens DCS platforms and OpCenter MES integration
• Strong knowledge of ISA-88 batch control standards, GAMP 5, and GxP-regulated environments
• Proven experience supporting capital projects in pharmaceutical manufacturing environments
• Experience in commissioning, qualification, and validation (CQV) activities
• Experience managing multiple vendors in EPC or multi-contractor environments
• Familiarity with integration of automation systems, MES, historians, and enterprise systems
• Strong leadership, communication, and stakeholder management skills
• Ability to work in cross-functional, fast-paced project environments