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). The role is responsible for overseeing the full automation stack (Levels 0-4), including process control systems, Siemens DCS, batch automation (ISA-88), MES (OpCenter), historians, and enterprise system integration. The position ensures design integrity, regulatory compliance (GAMP 5, GxP), and successful execution across design, commissioning, qualification, and validation phases. The role also involves coordination with vendors, system integrators, and cross-functional teams to deliver scalable and standardized automation solutions.
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
- Coordinate and manage system integrators, OEMs, and automation vendors
- Support full project lifecycle execution including design, FAT/SAT, commissioning, qualification, and validation activities
- 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
