Utilities Engineer, HVAC & Clean Systems

The Utilities Engineer is responsible for oversight of design engineering safety and quality support in the following utility equipment systems:

Clean Steam Purified Water WFI and RO Systems HVAC Systems Plant Steam Systems Co-Generation Units Process Chillers Compressed/Process Air Nitrogen Ammonia Chillers and Refrigeration Process Alcohol Distillation and Recovery Process Process Gases Natural Gas Bulk Chemical Distribution Solvent Gas Detection systems Fire Alarm Control and Protection Systems Electrical Systems Water Cooling towers and Waste Treatment systems for the Kankakee facility.

This individual will work closely with a cross-functional team to meet the needs of the groups they support.

• Role that this position reports to: Sr. Manager Utilities Engineering

• Positions reporting into this role: N/A

Responsibilities:

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 technical expertise and industry best practices

• Lead engineering 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.

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 PMs BOMs 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

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

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 (CAPAs and OOTs) with on-time closure

• Safely resolve process problems improve efficiency reduce waste and maximize uptime production

• Execute root cause analysis during investigations

• Lead investigations as the subject matter expert providing technical expertise for all phases associated with the utility systems

• Responsible for the development and maintenance of the utility drawings flow diagrams and Standard Operational documents.

• Perform utility inspections for qualityassurance on a periodic basis and initiate any procedures necessary to resolve problems

• Responsible for utility inspections (GEMBAs/audits) for qualityassurance 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.

scheduled capital project related utility system shutdowns tie-ins and system startup.

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.

with requirements from CSL Behrings Safety Program including Health and Safety mandates and OSHA requirements.

any other duties/responsibilities assigned by senior management.

Additional Responsibilities and Accountabilities (HVAC):

for HVAC cGMP facility design and improvement projects in Cleanrooms Labs etc.

for review and approval of Building HEPA Certification Filter and Testing Air Balance reports ensuring compliance to regulatory and industry standards (ISO).

expertise in all systems (GMP and non-GMP HVAC and ancillary systems associated within their operations) understanding their applications in pharmaceutical manufacturing understanding pressure cascade flow charts and process parameters.

HVAC equipment and prepare required reports.

Additional Responsibilities and Accountabilities (Clean System):

for providing engineering expertise to support the design installation commissioning validation and operation of the Clean Utility systems.
an essential leadership role in support of the operation on project support activities.
for the Clean Utility generation and distribution systems across the site. These systems include clean steam purified water clean air WFI clean gases and other ancillary equipment
for the quality requirements and the applicable regulatory standards such as USP EU and JP.
lead in engineering with a focus on pharmaceutical utility systems industry best practices and emerging technologies related to utility systems requirements.

Qualifications:

• Bachelors Degree in Chemical Electrical or Mechanical Engineering preferred or B.S. degree in an Engineering related field.

• 5 years experience as a utilities/facilities engineer with BS; 3 years experience as a utilities/facilities engineer with 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 CFRs.

• 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

The expected base salary range for this position at hiring is $98000 - $124000. Please note this salary range reflects the minimum and maximum base pay that CSL expects to pay for this position at the listed location as of the time of this posting. Individual base salary for a successful candidate is determined by qualifications skill level experience competencies and other relevant addition to base salary total compensation for this role may also include incentive compensation and equity.

About CSL Behring

CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients needs by using the latest technologies we discover develop and deliver innovative therapies for people living with conditions in the immunology hematology cardiovascular and metabolic respiratory and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation recombinant protein technology and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.

CSL Behring operates one of the worlds largest plasma collection networks CSL Plasma. Our parent company CSL headquartered in Melbourne Australia employs 32000 people and delivers its lifesaving therapies to people in more than 100 countries.

To learn more about CSL CSL Behring CSL Seqirus and CSL Vifor visit and CSL Plasma at Benefits

For more information on CSL benefits visit How CSL Supports Your Well-being CSL.

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