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Initial Therapeutics
Kankakee,IL

Description

Position PurposeThe Utilities Engineer is responsible for oversight of design, engineering, safety and quality 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. This individual will work closely with a cross‑functional team to meet the needs of the groups they support.Responsibilities1 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 systemsProvide engineering support to address operational / compliance issues and to ensure equipment is maintained at a level required to provide high reliability maximizing useful lifeImplement measures to improve equipment that support utility operationsProvide technical expertise and industry best practicesLead engineering efforts to resolve equipment and operational problems and ensure problem solving techniques are appropriately utilizedPrepares User Requirements Specifications (URS), Risk Assessments, Safety Assessments and participates in validation activities including review of IQ/OQ protocols, executions and summary reportsProvide technical support to operations, maintenance, manufacturing, automation, quality assurance, validation, reliability engineering and project engineeringSupport the planning and execution of activities by working in cross‑functional teams assisting in driving projects to completion to meet timeline and budget objectivesManage system documentation including creation, review, updates, and approval of technical specifications, operating procedures, and system drawings2 Accountable for the Utility Reliability Program:Execute the maintenance strategy for new and modified equipmentManagement of CMMS data integrity and execution of Reliability Centered Maintenance ImprovementsDevelop preventative maintenance procedures for utility systems in collaboration with the Reliability Engineering department ensuring maintenance programs are implementedContinuous Improvement of maintenance PM's, BOM's and Spare PartsReview and lead utility equipment replacement as part of the life cycle improvement process and continuous improvement initiative planningOversees reconditioning of the equipment to restore to like‑new conditionPerforms upgrades to improve safety, operational performance, and extend operational lifeCollaborates with local and global partners to develop asset management plan that includes capital requests3 Manage and monitor KPI's:Ensure compliance with site and global indicatorsMeasure and ensure compliant performance in Safety, Quality and ReliabilityDemonstrate success of preventative maintenance improvements through performance reports, dashboards and metricsUtilize control systems to monitor, trend and verify equipment performance and downtime4 Ensure cGMP compliance of all utility systems to meet regulatory compliance:Equipment is maintained at a level required to provide high reliability maximizing useful lifeReview environmental monitoring and laboratory sample release test resultsManage deviations, investigations (CAPA's and OOT's) with on‑time closureSafely resolve process problems, improve efficiency, reduce waste, and maximize uptime productionExecute root cause analysis during investigationsLead investigations as the subject matter expert providing technical expertise for all phases associated with the utility systemsResponsible for the development and maintenance of the utility drawings, flow diagrams and Standard Operational documentsPerform utility inspections for quality assurance on a periodic basis and initiate any procedures necessary to resolve problemsResponsible for utility inspections (GEMBA's/audits) for quality assurance on a periodic basisResponsible to ensure training, deviations and investigations related to utility systems have on‑time closure and KPI performance metrics are metResponsible for change control activities, the implementation of CAPA items, quality investigations and determine/implement long lasting corrective actions and preventative measures5 Support scheduled capital project related 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.Additional Responsibilities and Accountabilities (Clean System)Responsible for providing engineering expertise to support the design, installation, commissioning, validation and operation of the Clean Utility systemsPlay an essential leadership role in support of the operation on project support activitiesResponsible 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 equipmentResponsible for the quality requirements and the applicable regulatory standards, such as USP, EU and JPTechnical lead in engineering, with a focus on pharmaceutical utility systems, industry best practices, and emerging technologies related to utility systems requirementsQualificationsEducationBachelor's Degree in Chemical, Electrical or Mechanical Engineering preferred or B.S. degree in an Engineering related field.Experience5+ years of relevant experience and a BS3+ years of relevant experience and a MSMust 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'sMust have experience with mid-to-large capital projects for the pharmaceutical industryKnowledge of biopharmaceutical process operation and process control, utility and mechanical systems (pumps, valves, materials)Working knowledge of pharmaceutical process sanitary connections, valves and supply loopsExperience with Quality Management and Change Control SystemsKnowledge 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 supervisionDemonstrated ability to manage contractors, while interfacing with multiple departments, working with internal customers to manage projectsKnowledge of manufacturing processesExpected base salary range for this position at hiring is $98,000 - $124,000. 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 factors. In addition to base salary, total compensation for this role may also include incentive compensation and equity.Equal Opportunity EmployerCSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit

Turn Job Alerts On
Initial Therapeutics Logo
Initial Therapeutics
Kankakee,IL

Description

Position PurposeThe Utilities Engineer is responsible for oversight of design, engineering, safety and quality 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. This individual will work closely with a cross‑functional team to meet the needs of the groups they support.Responsibilities1 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 systemsProvide engineering support to address operational / compliance issues and to ensure equipment is maintained at a level required to provide high reliability maximizing useful lifeImplement measures to improve equipment that support utility operationsProvide technical expertise and industry best practicesLead engineering efforts to resolve equipment and operational problems and ensure problem solving techniques are appropriately utilizedPrepares User Requirements Specifications (URS), Risk Assessments, Safety Assessments and participates in validation activities including review of IQ/OQ protocols, executions and summary reportsProvide technical support to operations, maintenance, manufacturing, automation, quality assurance, validation, reliability engineering and project engineeringSupport the planning and execution of activities by working in cross‑functional teams assisting in driving projects to completion to meet timeline and budget objectivesManage system documentation including creation, review, updates, and approval of technical specifications, operating procedures, and system drawings2 Accountable for the Utility Reliability Program:Execute the maintenance strategy for new and modified equipmentManagement of CMMS data integrity and execution of Reliability Centered Maintenance ImprovementsDevelop preventative maintenance procedures for utility systems in collaboration with the Reliability Engineering department ensuring maintenance programs are implementedContinuous Improvement of maintenance PM's, BOM's and Spare PartsReview and lead utility equipment replacement as part of the life cycle improvement process and continuous improvement initiative planningOversees reconditioning of the equipment to restore to like‑new conditionPerforms upgrades to improve safety, operational performance, and extend operational lifeCollaborates with local and global partners to develop asset management plan that includes capital requests3 Manage and monitor KPI's:Ensure compliance with site and global indicatorsMeasure and ensure compliant performance in Safety, Quality and ReliabilityDemonstrate success of preventative maintenance improvements through performance reports, dashboards and metricsUtilize control systems to monitor, trend and verify equipment performance and downtime4 Ensure cGMP compliance of all utility systems to meet regulatory compliance:Equipment is maintained at a level required to provide high reliability maximizing useful lifeReview environmental monitoring and laboratory sample release test resultsManage deviations, investigations (CAPA's and OOT's) with on‑time closureSafely resolve process problems, improve efficiency, reduce waste, and maximize uptime productionExecute root cause analysis during investigationsLead investigations as the subject matter expert providing technical expertise for all phases associated with the utility systemsResponsible for the development and maintenance of the utility drawings, flow diagrams and Standard Operational documentsPerform utility inspections for quality assurance on a periodic basis and initiate any procedures necessary to resolve problemsResponsible for utility inspections (GEMBA's/audits) for quality assurance on a periodic basisResponsible to ensure training, deviations and investigations related to utility systems have on‑time closure and KPI performance metrics are metResponsible for change control activities, the implementation of CAPA items, quality investigations and determine/implement long lasting corrective actions and preventative measures5 Support scheduled capital project related 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.Additional Responsibilities and Accountabilities (Clean System)Responsible for providing engineering expertise to support the design, installation, commissioning, validation and operation of the Clean Utility systemsPlay an essential leadership role in support of the operation on project support activitiesResponsible 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 equipmentResponsible for the quality requirements and the applicable regulatory standards, such as USP, EU and JPTechnical lead in engineering, with a focus on pharmaceutical utility systems, industry best practices, and emerging technologies related to utility systems requirementsQualificationsEducationBachelor's Degree in Chemical, Electrical or Mechanical Engineering preferred or B.S. degree in an Engineering related field.Experience5+ years of relevant experience and a BS3+ years of relevant experience and a MSMust 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'sMust have experience with mid-to-large capital projects for the pharmaceutical industryKnowledge of biopharmaceutical process operation and process control, utility and mechanical systems (pumps, valves, materials)Working knowledge of pharmaceutical process sanitary connections, valves and supply loopsExperience with Quality Management and Change Control SystemsKnowledge 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 supervisionDemonstrated ability to manage contractors, while interfacing with multiple departments, working with internal customers to manage projectsKnowledge of manufacturing processesExpected base salary range for this position at hiring is $98,000 - $124,000. 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 factors. In addition to base salary, total compensation for this role may also include incentive compensation and equity.Equal Opportunity EmployerCSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit


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