Allosource Sr Engineer, AV Access in Centennial, Colorado

For more than 20 years, AlloSource s allografts have been the biologicsolutions our surgeon customers use to deliver better care to their patients.As one of the largest and most respected nonprofit tissue banks in the UnitedStates, AlloSource develops, processes and distributes over 200 types oflife-saving and life-enhancing allografts for use in a variety of medicalprocedures. Our commitment to honoring the gift of tissue donation motivatesus to develop innovative allografts and lead the way in cellular and tissuetheCompliance StatementMust comply and ensure adherence with FDA, CGTP, OSHA, AlloSourceSOPs, work instructions & procedures, proper practices and techniques,AATB standards, and applicable company policies, training requirements,safety practices and regulatory requirements that are applicable to the jobresSummaryThe Sr. Engineer, Arteriovenous (AV) Access will be the technicalprocess engineering expert related to vessel and cell production. Thisincludes managing related projects, developing new equipment, processesand systems. Existing operation equipment/processes/systems will also besupported on a day to day basis, including but not limited to standardbioprocess skills, maintenance of common laboratory equipment,process/product engineering, documentation, equipmentvalidation/verification, specification creation and resolution ofproduction processing issues. Responsible for partnering with all keystakeholders to ensure deadlines/statuses and desired end results areachieved and communicated in a timely and efficient mannerEssential Duties and Responsibilities: Responsible for technical troubleshooting of GMP manufacturing issues inclinical study and commercial product manufacturing. Implementation and management of systems that ensure regular and routinecalibration, maintenance and repair when equipment malfunctions. Operational coverage in AV Access, on an as needed basis;(including routine cell culture and bioreactor processes). Support manufacturing in the form of operational process improvements,oversight of tech transfer of changes recommended by contract manufacturingpartner and/or to implement lean manufacturing improvements to existingprocess Provide timely technical support to manufacturing on novel and basicbioprocess equipment, ensuring consistent and reliable operations toinclude bioreactors, incubators, blood gas analysis, pressure sensingand monitoring, etc. 
 Provide technical support with external vendors who provide GMP rawmaterials when investigations and changes to raw materials are necessary.̷ Draft and execute process and equipment verification and validations. Provide written technical background/rationale in response tonon-conformance events in manufacturing 
 Track, analyze and respond to in-process data tracked in on-goingproduction batches to identify potential manufacturing issues and processdrift. Provide feedback to production team as appropriate. Primary interface with Humacyte process development and engineeringteams. Assist process development team in testing prototype equipment for theproduction of tissue engineered products in bioreactors. Assist withtechnology transfer to commercial scale. Oversee transition of newly developed methods to manufacturing tomaintain compliance with regulatory and quality control requirements. 
 Participates in special projects and support Operations activity on anas needed basis. Participates in financial objectives and performance goals. Adheres to and promotes proper practices and techniques which areconsistent with current operating procedures, training requirements,safety practices and company policies.Requirements: Bachelor s degree in an Engineering discipline 5 years engineering, directly supporting operations, validationequipment/processes and addressing customer issues Solid analytical, problem solving and innovative skills are requiredto apply to new methodologies addressing unique and new compan