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Purpose:

The Utilities Engineer is responsible for oversight of design, operational and troubleshooting support in the following utility equipment systems:

Clean Utilities (Clean Steam, Purified Water, WFI and 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 for the Kankakee facility.

Primary focus is on the site’s Potable Water, Storm water and Waste Treatment systems.

Responsibilities:

1

Technical lead accountable for the operational improvement of the utility systems based upon industry trends and emerging technologies:  

• Responsible for compliance and operational improvement of equipment systems
• Provide engineering support to address operational / compliance issues and to ensure equipment is maintained at a level required to provide high reliability maximizing useful life
• Implement measures to improve equipment that support utility operations  
• Provide support in all matters pertaining to engineering, operations and maintenance of the equipment systems
• Provide technical expertise and industry best practices
• Lead troubleshooting efforts to resolve equipment and operational problems and ensure problem solving techniques are appropriately utilized
• Prepares User Requirements Specifications (URS), Risk Assessments, Safety Assessments and participates in validation activities including review of IQ/OQ protocols, executions and summary reports.
• Provide technical support to operations, maintenance, manufacturing, automation, quality assurance, validation, reliability engineering and project engineering.
• Support the planning and execution of activities by working in cross-functional teams assisting in driving projects to completion to meet timeline and budget objectives
• Manage system documentation including creation, review, updates, and approval of technical specifications, operating procedures, and system drawings.

2

Accountable for the Utility Reliability Program:

• Execute the maintenance strategy for new and modified equipment
• Management of CMMS data integrity and execution of Reliability Centered Maintenance Improvements
• Develop preventative maintenance procedures for utility systems in collaboration with the Reliability Engineering department ensuring maintenance programs are implemented
• Continuous Improvement of maintenance PM’s, BOM’s and Spare Parts
• Review and lead utility equipment replacement as part of the life cycle improvement process and continuous improvement initiative planning.
• Oversees reconditioning of the equipment to restore to like-new condition
• Performs upgrades to improve safety, operational performance, and extend operational life
• Collaborates with local and global partners to develop asset management plan that includes capital requests

3

Manage and monitor KPI’s:

• 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

4

Ensure cGMP compliance of all utility systems to meet regulatory compliance:

• Equipment is maintained at a level required to provide high reliability maximizing useful life
• Review environmental monitoring and laboratory sample release test results
• Manage deviations, investigations (CAPA’s and OOT’s) with on-time closure
• Safely resolve process problems, improve efficiency, reduce waste, and maximize uptime production
• Execute root cause analysis around equipment and operational events, owning change controls, investigations
• Lead investigations as the subject matter expert providing technical expertise for all phases associated with the operation and troubleshooting of the utility systems
• Responsible for the development and maintenance of the utility drawings, flow diagrams and Standard Operational documents.
• Perform utility inspections for quality assurance on a periodic basis and initiate any procedures necessary to resolve problems
• Responsible for utility inspections (GEMBA’s/audits) for quality assurance on a periodic basis.
• Responsible to ensure training, deviations and investigations related to utility systems have on-time closure and KPI performance metrics are met
• Responsible for change control activities, the implementation of CAPA items, quality investigations and determine/implement long lasting corrective actions and preventative measures.

5

Required to support all scheduled utility system shutdowns, tie-ins and system startup.

6

Demonstrate continuous improvement with respect to increasing job knowledge and proficiency related to biopharmaceutical industry engineering best practices and technologies, as well as technical understanding/problem solving capability.

7

Complies with requirements from CSL Behring’s Safety Program, including Health and Safety mandates and OSHA requirements.

8

Completes any other duties/responsibilities assigned by senior management.

Waste Water:

1

Perform calculations for proper mixture, chemical flow rate based on engineering principles maintaining compliance to federal, state, and local regulations.

2

Participates in operations activities to review, analyze and interpret environmental monitoring data along with reviewing wastewater permit and permit compliance.

3

Assist with environmental laboratory technical studies, which may include reviewing sample collections, laboratory tests and analyses.

4

Performs data evaluation, design support, assist with reviewing hydraulic analysis and modeling of water and wastewater systems.

5

Support daily operations of the wastewater system and equipment.

6

Oversee the overall equipment lifecycle of the site's wastewater system; including pH neutralization, anaerobic and aerobic treatment processes, dissolved air floatation, dewatering centrifugation, and chemical feed systems

7

Collect and analyze data for use by the operations manager to ensure reliable operation of the wastewater systems.

Education:

Bachelor’s Degree in Chemical, Environmental or Mechanical Engineering preferred or B.S. degree in an Engineering related field.

Experience:

• 5+ years of relevant experience and a BS

• 3+ years of relevant experience and a MS

• Must possess basic knowledge of core principles in various engineering disciplines (fluid mechanics, heat transfer, thermodynamics etc.)

• Strong knowledge of utility systems (Clean and Plant Utility Systems)

• Strong knowledge of industry standards and guidelines such as ASME BPE, ISPE Baseline Guides, USP, EU GMP, ISO standards and CFR’s.

• Must have experience with mid-to-large capital projects for the pharmaceutical industry.

• Knowledge of biopharmaceutical process operation and 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 the ability to work in collaborative and independent work situations and environments with minimal supervision.

• Demonstrated ability to manage contractors, while interfacing with multiple departments, working with internal customers to manage projects.

• Knowledge of manufacturing processes

• Computer skills: MS Project and AutoCAD preferred

Different qualifications or responsibilities may apply based on local legal and/or educational requirements. Refer to local job documentation where applicable.

CSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals.

Please take the time to review our benefits site to see what’s available to you as a CSL employee.

CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring.

As a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL.