Terumo BCT Engineer 3 - Process Validation in Lakewood, Colorado

Engineer 3 - Process ValidationDate: Jan 8, 2019Location:Lakewood, CO, US Company: Terumo BCT, Inc.Requisition ID: 22882JOB SUMMARYThis is an engineering role on the Process Validation team with an emphasis onethylene oxide sterilization. This position will be responsible for validatingnew high-volume sterilization equipment and processes. Work will involveassessing product and process risk(s), understanding equipment andprocess parameters, writing, executing and reviewing protocols andreports, and ensuring the validation of manufacturing processes arecompliant with applicable internal procedures and external standards.ESSENTIAL DUTIESDesign, execution, analysis and approval of manufacturing IQ, OQ and PQprotocols and reports.Perform independent evaluation, selection, and application in makingadaptations and modifications to projects.Receives assigned total project leadership responsibilities on a portion ofmajor significant projects and will be given total management responsibilityfor smaller projects.Manages and provides leadership for the functional group's development,direction, and effectiveness, adhering to organizational policies andprocesses and supporting overall business and corporate objectives.Implements and understands FDA or regulatory requirements as necessary.Applies technology principles to multiple tasks. Working knowledge ofcross-functional and related technical areas.Highlights risks and understands how to approach and complete tasks,avoiding serious delays and considerable expenditure of time and resources.Advises team members pro-actively on technical ideas and promotes skilldevelopment of team work.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 respondsto questions 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's degree or equivalent of education and experience sufficient tosuccessfully perform the essential functions of the job may be considered.Bachelor of Science Degree in Engineering, preferred.ExperienceMinimum 5 years experience.Two years of GMP manufacturing experience required.SkillsRequires demonstrated skills in technical innovation, technicalleadership, mechanical and or chemical engineering, fluids engineering,and cellular biology.Strong interactive skills in general communication, cross-functionalparticipation and influence, mentoring and acceptance of guidance,technical leadership, project management, coordination withcross-functional team member, team behavior, and support forsubordinates, junior engineers, technicians, and management.Strong technical problem solving skills.Mechanical and electronic ability aptitude to assist with equipmenttrouble-shooting.Understanding of and adherence to GMP practices and FDA regulations.Knowledge and ability to implement FDA or regulatory requirements asnecessary.Demonstrated ability to communicate effectively both verbally and in writing.Knowledge and use of relevant PC software applications and skills to use themeffectively.-Or-An equivalent competency level acquired through a variation of thesequalifications may be considered.PHYSICAL REQUIREMENTSGeneral Labor Environment requirements include: use of personal protectiveequipment, reading, speaking, hearing, walking, bend