Terumo BCT Global Sterilization Engineer 4 in Lakewood, Colorado

Global Sterilization Engineer 4Date: May 8, 2018Location:Lakewood, CO, US Company: Terumo BCT, Inc.State: Colorado (US-CO)JOB TITLE: Global Sterilization SpecialistJOB SUMMARYThis position provides sterilization expertise to the organization with focuson; cycle/aeration process development, facility expansion,facility/process improvement, operational consistency, and personneldevelopment to establish sterilization competency across the organization.This person will develop, establish, and maintain methodologies,systems, and practices which meet Terumo BCT, customer, and regulatoryrequirements. This is a "hands on" position that requires ahard-working, detail-oriented professional with extensive experience in amedical device manufacturing/sterilization environment, with excellentleadershESSENTIAL DUTIESProvide guidance for sterilization activities worldwide.Stays abreast of current technologies and regulatory Standards and theirapplication.Ensure global compliance to cGMPs and AAMI/ISO Standards for Sterilization.Provide guidance and leadership in the development, establishment, andvalidation of sterilization/manufacturing processes to drive consistencyacross operations.Provide sterilization expertise for initiatives to develop new products oroptimize existing sterilization processes.Identifies and implements effective process control systems to support thedevelopment, qualification, and ongoing operation of sterilization facilities.Provides guidance, training, mentoring of new and existing sterilizationleaders and associates.Provide guidance on regulatory requirements, technologies, and engineeringcontrols to ensure compliance with health, safety, and environmentalregulations specific to sterilization operations.Prepare/review capital and expense forecasts for sterilization projects andinitiatives.Coordinate cross functional teams to drive business and organizationalresults.Work collaboratively with sterility assurance experts to develop/modifysterilization processes for new or existing products and to develop,review, and approve sterilization process qualifications.Work collaboratively with validation engineering to ensure that sterilizationprocesses, equipment, and software are validated in compliance withregulatory Standards and Terumo BCT procedures.Applies sound, systematic problem-solving methodologies in identifying,prioritizing, communicating, and resolving sterilization issues.Receive strategic guidance from business unit management and keep managementwell informed of all major problems, improvement activities, and potentialbarriers.Provide audit support.MINIMUM QUALIFICATION REQUIREMENTSEducationBachelor of Science degree in Engineering or 15+ years equivalent experiencein medical device Sterilization engineering and/or operations management.ExperienceHands-on experience in sterilization including: operations, logistics,process controls, validation IOPQ, facility design/construction, EHSissues, equipment specification, capital purchasing, process optimization,Application of national and international standards to process development,process validation, and sterilization operationsSterilization cycle optimizationDevelopment and maintenance of equipment and process specifications andprocedures.Establishment of Maintenance and Calibration programs for sterilizationfacility.Specification, design, and validation of software for sterilizationchambers, aeration room, ancillary systems, and Supervisory Control AndData Acquisition (SCADA) systems.Strong associate development skills. Sharing and building skills within othersfor robust succession planning.Business continuity planningSkillsExcellent written and oral communication skills.Self-motivated, courageous, and self-assured individual with high personalintegrity and ability to collaborate, influence and develop positiveinterpersonal relationships.Ability to make sound decisions based on scientific principles, raw data,and interpretation of medical device regulations