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Terumo BCT Validation Engineer 3 in Lakewood, Colorado

Validation Engineer 3 Please wait...Date: Nov 16, 2020Location:Lakewood, CO, US Company: Terumo BCT, Inc.Requisition ID: 26785At Terumo Blood and Cell Technologies, our 7,000+ global associatesproud to come to work each day, knowing that what we do impacts the lives ofpatients around the world.We make medical devices and related products that are used to collect,separate, manufacture and process various components of blood and cells.With our innovative technologies and service offerings, we touch apatient's life every second of every day and are committed to continuing toincrease the number of patients we serve.With some of the best and brightest minds in the industry, an unmatchedglobal footprint, comprehensive benefits and a distinct culture, TerumoBlood and Cell Technologies is a great place to work, grow and be part of ateam that is focused on making a difference. Consider joining our team andunlock your potential.The Product Quality Validation Engineer will be responsible for generatingvalidations for Terumo BCT and Test Method Validation activities, whichincludes reviewing process parameters and requirements, assessing productand process risk, and understanding equipment to be utilized. This positionwill also be responsible for supporting process and test method validationactivities as needed by the team; this includes but is not limited tomaintaining the validation master plan, reviewing protocol and reportdocuments, and ensuring the procedures used to validate processes areadhered tWork requires the use of judgment with respect to the application andadaptation of standard techniques, procedures, and criteriaESSENTIAL DUTIESIndependently performs validation activities as dictated by assigned projectresponsibilities.Project lead assuming responsibilities for major projects and various smallerprojects.Implements and understands FDA or regulatory requirements as necessary.Demonstrated ability to work independently and lead cross-functional teams.Ability to plan schedules and provide creative solutions to address potentialschedule delays.Interacts with peers across projects to secure resources and commitments.Handles frequent inter-organizational and outside customer contacts.Represents the organization in providing solutions to difficult technicalissues associated with specific projects.Follows technical specification requirements and provides feedback on varioustechnical processes and procedures.Presents effectively complex technical information/analysis and responds toquestions from technical staff members and management.Works cooperatively and effectively within a team environment to achievecommon goals and results, often influencing the outcome of the team(s).OTHER DUTIES AND RESPONSIBILITIESWork direction responsibility may include technicians and junior engineers.May work with manufacturing and other functional groups on manufacturing andregulatory compliance issues.MINIMUM QUALIFICATION REQUIREMENTSEducationBachelor of Science Degree in Engineering, preferred.Bachelor's degree or equivalent of education and experience sufficient tosuccessfully perform the essential functions of the job may be considered.ExperienceMinimum 5 years' experience.Two years of GMP manufacturing experience required.SkillsRequires demonstrated skills in technical innovation, technicalleadership, mechanical, chemical engineering, industrial, orelectrical engineering.Strong interactive skills in communication, cross-functional teaminteractions, technical leadership, project management, and support forsubordinates, junior engineers, technicians, and management.Strong technical problem-solving skills. Strong graphical and statisticalanalysis skillsMechanical and electronic ability aptitude to assist with equipmenttroubleshooting.Understanding of and adherence to GMP practices and FDA regulations.Understanding of measurement system analysis and test method validationapproaches.Knowledge and ability