Utilities Engineer, Clean Systems

Responsible for oversight of design, engineering, safety, and quality support for utility equipment systems at the Kankakee facility, including Clean Utilities (Clean Steam, Purified Water, WFI, RO Systems), HVAC Systems, Plant Steam Systems, Co-Generation Units, Process Chillers, Compressed/Process Air, Ammonia Chillers and Refrigeration Process, Alcohol Distillation and Recovery Process, Process Gases, Natural Gas, Bulk Chemical Distribution, Solvent Gas Detection systems, Water, Cooling Towers, and Waste Treatment systems. Works closely with cross-functional teams to meet operational needs.

Responsibilities

• Technical lead accountable for operational improvement of utility systems based on industry trends and emerging technologies:
  • Ensure compliance and operational improvement of equipment systems.
  • Provide engineering support to address operational/compliance issues and maintain high reliability to maximize equipment life.
  • Implement measures to improve utility operations.
  • Provide technical expertise and industry best practices.
  • Lead engineering efforts to resolve equipment and operational problems using appropriate problem-solving techniques.
  • Prepare User Requirements Specifications (URS), Risk Assessments, Safety Assessments, and participate in validation activities (IQ/OQ protocols, executions, and summary reports).
  • Provide technical support to operations, maintenance, manufacturing, automation, quality assurance, validation, and reliability engineering.
  • Support planning and execution of cross-functional projects to meet timeline and budget objectives.
  • Manage system documentation, including creation, review, updates, and approval of technical specifications, operating procedures, and system drawings.
• Accountable for the Utility Reliability Program:
  • Execute maintenance strategy for new and modified equipment.
  • Manage CMMS data integrity and Reliability Centered Maintenance improvements.
  • Develop preventative maintenance procedures for utility systems in collaboration with Reliability Engineering.
  • Continuously improve maintenance PMs, BOMs, and spare parts.
  • Review and lead utility equipment replacement as part of lifecycle improvement and continuous improvement initiatives.
  • Oversee equipment reconditioning to restore to like-new condition.
  • Perform upgrades to improve safety, operational performance, and extend equipment life.
  • Collaborate with local and global partners to develop asset management plans, including capital requests.
• Manage and Monitor KPIs:
  • Ensure compliance with site and global indicators.
  • Measure and ensure compliant performance in Safety, Quality, and Reliability.
  • Demonstrate success of preventative maintenance improvements through performance reports, dashboards, and metrics.
  • Utilize control systems to monitor, trend, and verify equipment performance and downtime.
• Ensure cGMP compliance of all utility systems to meet regulatory requirements:
  • Maintain equipment reliability to maximize uptime.
  • Review environmental monitoring and laboratory sample release test results.
  • Manage deviations, investigations (CAPAs and OOTs) with on-time closure.
  • Safely resolve process problems, improve efficiency, reduce waste, and maximize production uptime.
  • Execute root cause analysis during investigations.
  • Lead investigations as the subject matter expert for utility systems.
  • Develop and maintain utility drawings, flow diagrams, and Standard Operational documents.
  • Perform utility inspections for quality assurance and initiate corrective procedures as needed.
  • Ensure training, deviations, and investigations related to utility systems have on-time closure and KPI performance metrics are met.
  • Responsible for change control activities, CAPA implementation, quality investigations, and long-lasting corrective/preventative measures.
• Support scheduled capital project-related utility system shutdowns, tie-ins, and system startups.
• Demonstrate continuous improvement in job knowledge and proficiency related to biopharmaceutical industry engineering best practices and technologies.
• Comply with CSL Behring’s Safety Program, including Health and Safety mandates and OSHA requirements.
• Complete additional duties/responsibilities as assigned by senior management.
• Clean System Responsibilities:
  • Provide engineering expertise for design, installation, commissioning, validation, and operation of Clean Utility systems.
  • Lead project support activities for Clean Utility systems.
  • Oversee Clean Utility generation and distribution systems (clean steam, purified water, clean air, WFI, clean gases, and ancillary equipment).
  • Ensure quality requirements and regulatory standards (USP, EU, JP) are met.
  • Serve as technical lead in engineering with a focus on pharmaceutical utility systems, industry best practices, and emerging technologies.

Requirements

• Bachelor’s Degree in Chemical, Electrical, or Mechanical Engineering preferred, or a B.S. degree in an Engineering-related field.
• 5+ years of relevant experience with a BS, or 3+ years with an MS.
• Basic knowledge of core engineering principles (fluid mechanics, heat transfer, thermodynamics).
• Strong knowledge of utility systems (Clean and Plant Utility Systems).
• Familiarity with industry standards and guidelines (ASME BPE, ISPE Baseline Guides, USP, EU GMP, ISO standards, CFRs).
• Experience with mid-to-large capital projects in the pharmaceutical industry.
• Knowledge of biopharmaceutical process operation, process control, utility, and mechanical systems (pumps, valves, materials).
• Working knowledge of pharmaceutical process sanitary connections, valves, and supply loops.
• Experience with Quality Management and Change Control Systems.
• Knowledge of Computerized Maintenance Management Systems (CMMS).
• Excellent problem-solving skills and ability to work collaboratively and independently with minimal supervision.
• Demonstrated ability to manage contractors and interface with multiple departments.
• Knowledge of manufacturing processes.

Pay

The expected base salary range for this position is $98,000 - $124,000. Individual base salary is determined by qualifications, skill level, experience, competencies, and other relevant factors. Total compensation may also include incentive compensation and equity.