Utilities Engineer

CSL Behring•Kankakee, IL

About The Position

The Utilities Engineer is responsible for 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, Process Chillers, Compressed/Process Air, Nitrogen, Refrigeration Process, Alcohol Distillation and Recovery Process systems for the Kankakee facility. This individual will work closely with a cross-functional team to meet the needs of the groups they support.

Requirements

Bachelor’s Degree in Chemical, Electrical or Mechanical Engineering preferred or B.S. degree in an Engineering related field.
1+ years of engineering experience in a GMP or highly regulated environment.
Must possess basic knowledge of core principles in various engineering disciplines (fluid mechanics, heat transfer, thermodynamics etc.).
Knowledge of utility systems (Clean and Plant Utility Systems).
Knowledge of electrical power distribution at 115kV, 15kV and 480v.
Knowledge of industry standards and guidelines such as ASME BPE, ISPE Baseline Guides, USP, EU GMP, ISO standards and CFR’s.
Knowledge of biopharmaceutical process operation and process control, utility and mechanical systems (pumps, valves, materials).
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.
Computer skills: MS Project and AutoCAD preferred.

Responsibilities

Accountable for the operational improvement of the utility systems based upon industry trends and emerging technologies: 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. Provide engineering support to operations, maintenance, manufacturing, automation, quality assurance, validation, reliability engineering and project engineering. Manage system documentation including creation, review, updates, and approval of technical specifications, operating procedures, and system drawings.
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.
Manage and monitor KPI’s: Measure and ensure compliant performance in Safety, Quality and Reliability. Utilize control systems to monitor, trend and verify equipment performance and downtime.
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. Support root cause analysis during investigations. Ensure training have on-time closure, and KPI performance metrics are met.
Support all scheduled capital projects related to utility system shutdowns, tie-ins and system startup.
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.