SME Engineer - Utilities

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

Clean Utilities (Clean Steam, Purified Water, WFI and RO Systems), HVAC Systems, Boiler/ Steam Systems, Co-Generation Units, Process Chillers, Compressed/Process Air, Ammonia Chillers and Refrigeration Process, Alcohol Distillation and Recovery Process, Process Gases, Bulk Chemical Distribution, Solvent Gas Detection systems, Electrical Generation and Distribution Systems, Potable water, Fire water, Cooling towers, Waste systems and the Building Management Systems (BMS) for the Kankakee facility.

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

Responsibilities:

• Responsible for providing engineering expertise to support the design, installation, commissioning, validation and operation of the utility systems.
• Review and lead utility equipment replacement as part of the life cycle improvement process and continuous improvement initiative planning.
• Provide technical support to operations, maintenance, manufacturing, automation, quality assurance, validation, reliability engineering and project engineering.
• Lead investigations as the subject matter expert providing technical expertise for all phases associated with the operation and troubleshooting of the utility systems.
• Perform utility inspections for quality assurance on a periodic basis and initiate any procedures necessary to resolve problems.
• 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.
• 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.
• Manage small-scale projects, creating scope of work, justification, cost estimates and implementing purchase order requisitions.
• Prepares User Requirements Specifications (URS), Risk Assessments, Safety Assessments and participates in validation activities including review of IQ/OQ protocols, executions and summary reports.
• Must be familiar with plant and divisional procedures as related to positional and department responsibilities and stay current with assigned training to ensure compliance with quality and safety program.
• Develop preventative maintenance procedures for utility systems in collaboration with the Reliability Engineering department ensuring maintenance programs are implemented.
• Support scheduled utility system shutdowns, tie-ins and system startup.
• Supports annual Energy Performance Workshop and output of the performance plan.
• 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.
• Complies with requirements from CSL Behring’s Safety Program, including Health and Safety mandates and OSHA requirements.
• Completes any other duties/responsibilities assigned by senior management.

Qualifications:

• Bachelor’s Degree in Chemical, Electrical or Mechanical Engineering preferred or B.S. degree in an Engineering related field.
• 5+ years of experience in an engineering role in support of a large industrial, pharmaceutical, biotechnology or FDA regulated facility.
• 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), cGMP and FDA regulated environments. 
• 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.

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