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). 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 requirementsLead and participate in design reviews, including User Requirement Specifications (URS), Functional Specifications, and Design SpecificationsPromote modular design, standardization, and scalable automation architecturesDrive automation risk management activities, including GxP assessments and system risk assessmentsCoordinate and manage system integrators, OEMs, and automation vendorsSupport full project lifecycle execution including design, FAT/SAT, commissioning, qualification, and validation activitiesCollaborate with engineering, manufacturing, quality, and validation teams to ensure successful project deliveryIdentify technical risks and implement mitigation strategies, supporting issue resolution throughout the project lifecycleEnsure alignment of automation systems with project standards and operational objectives Education & Experience Strong experience in pharmaceutical or biotech automation and process control systemsHands-on experience with Siemens DCS platforms and OpCenter MES integrationStrong knowledge of ISA-88 batch control standards, GAMP 5, and GxP-regulated environmentsProven experience supporting capital projects in pharmaceutical manufacturing environmentsExperience in commissioning, qualification, and validation (CQV) activitiesExperience managing multiple vendors in EPC or multi-contractor environmentsFamiliarity with integration of automation systems, MES, historians, and enterprise systemsStrong leadership, communication, and stakeholder management skillsAbility to work in cross-functional, fast-paced project environments