Utilities Engineer, Clean Systems

CSL Behring is seeking a Utilities Engineer, Clean Systems to lead the design, engineering, safety and quality oversight for Clean Utilities and related systems at its Bradley, Illinois site. The role centers on ensuring reliable utility operations, driving the Utility Reliability Program, managing KPIs, maintaining cGMP compliance and supporting capital projects. This onsite position collaborates across operations, maintenance, quality and validation to maximize equipment life and regulatory adherence.

Based in Bradley, IL, the engineer will integrate multi-disciplinary engineering knowledge with hands-on project execution, partnering with local and global teams to optimize asset performance and compliance.

Responsibilities

• Ensure compliance and drive operational improvements for utility equipment systems.
• Provide engineering support to address operational and compliance issues, maintaining equipment at high reliability and extended useful life.
• Develop and implement enhancements to equipment that supports utility operations.
• Share technical expertise and apply industry best practices across projects.
• Lead engineering efforts to diagnose and resolve equipment and process problems using appropriate problem-solving approaches.
• Prepare URS, risk assessments and safety assessments; participate in validation activities including IQ/OQ reviews and summary reports.
• Offer technical support to operations, maintenance, manufacturing, automation, QA, validation, reliability engineering and project engineering teams.
• Collaborate in cross-functional teams to plan and execute projects within timeline and budget objectives.
• Manage system documentation, including the creation, review and updates of technical specifications, SOPs and system drawings.
• Implement maintenance strategies for new and modified equipment.
• Maintain CMMS data integrity and drive Reliability Centered Maintenance improvements.
• Develop preventive maintenance procedures for utility systems with Reliability Engineering oversight to ensure program implementation.
• Continuously improve maintenance PMs, BOMs and spare parts availability.
• Review and lead utility equipment replacement as part of lifecycle and continuous improvement initiatives.
• Oversee reconditioning of equipment to restore like-new condition and perform safety- and performance-driven upgrades.
• Collaborate with local and global partners to develop asset management plans including capital requests.
• Ensure alignment with site and global indicators, and measure performance in safety, quality and reliability.
• Demonstrate the impact of preventive maintenance through reports, dashboards and metrics; monitor equipment with control systems for performance and downtime trends.
• Review environmental monitoring and laboratory release results; manage deviations and investigations (CAPAs and OOTs) with on-time closure.
• Resolve process problems safely, improve efficiency, reduce waste and maximize uptime; conduct root cause analyses and lead investigations as the utility systems SME.
• Develop and maintain utility drawings, flow diagrams and standard operating documents; perform periodic utility inspections for QA and initiate corrective actions.
• Lead utility-related inspections (GEMBAs/audits) for QA; ensure on-time closure of training, deviations and investigations with KPI alignment.
• Oversee change control activities, CAPA implementation and long-lasting corrective actions; support scheduled capital projects, shutdowns, tie-ins and startups.
• Pursue continuous improvement in biopharmaceutical engineering practices and technologies; comply with CSL Behring safety programs and OSHA requirements.
• Fulfill additional duties as assigned by senior management.

Clean System Specific Responsibilities

• Provide engineering expertise to design, install, commission, validate and operate Clean Utility systems.
• Assume a leadership role in project support activities related to clean utilities.
• Manage Clean Utility generation and distribution across the site, including clean steam, purified water, clean air, WFI, clean gases and related equipment.
• Ensure quality requirements and regulatory standards (USP, EU, JP) are met and maintained.
• Serve as the technical lead for pharmaceutical utility systems, applying best practices and evaluating emerging technologies.

Requirements

• Bachelor's degree in Chemical, Electrical or Mechanical Engineering with 5+ years of relevant experience; or a Master’s degree in these fields with 3+ years of relevant experience.
• Foundational knowledge of core engineering principles (fluid mechanics, heat transfer, thermodynamics, etc.).
• Strong knowledge of utility systems (clean and plant utilities) and familiarity with industry standards such as ASME BPE, ISPE Baseline Guides, USP, EU GMP, ISO standards and CFRs.
• Experience with mid-to-large pharmaceutical capital projects; understanding of biopharmaceutical process operation, process control, utility and mechanical systems (pumps, valves, materials).
• Working familiarity with pharmaceutical sanitary connections, valves and supply loops; experience with Quality Management and Change Control Systems.
• Proficiency with CMMS and strong problem-solving abilities; capable of independent work and collaborative projects with multiple departments.
• Ability to manage contractors and interface with internal customers to drive projects to completion; knowledge of manufacturing processes.

Technologies

• CMMS

Compensation

Salary: USD 98,000 - 124,000 per year