US-NorthCarolina-Durham: Bio Integration Specialist

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Date: 15-Sep-2009

Bio Integration Specialist



Principal Duties and Responsibilities (Essential Functions) •Participate on team to establish bioprocess devices specifications and influence designs that ensure integrity and success of in ovo administration are maintained. Effectively communicate specifications to Engineering development teams and to device validation teams. Participate in the development and introduction of new test and validation technologies and analytical methods to ensure continuous improvement. •Interact with appropriate cross functional groups to coordinate bioprocess alpha tests to de-bug bio-mechanical devices both in house and in the field while maintaining biological integrity. Manage relationships with internal and external customers to ensure tests minimize negative impact. •Participate in the development and implementation of device cleaning validation methods and analytical tests. Assist with optimizing operation and effectiveness for clean-in-place equipment and associated control systems. Troubleshoot and correct problems with existing equipment and processes •Assist in the design and conduct of alpha tests and protocols for bioprocess functionality, equipment and process validation, durability testing, target animal safety and efficacy and product potency and purity. Provide technical consultation and specifications to Device Validation for beta tests. •Participates in the execution of device performance evaluations of new biomechanical designs and requested modifications within in-house and real production test settings. This evaluation includes software and hardware evaluations against bioprocess performance. Evaluations will support commercialization of new device designs. Directly responsible for maintaining and improving established relationships with customers. •Participate in problem solving and troubleshooting for existing processes. Write related documents including SOPs, validation protocols and evaluation documents in a team environment. •Provide biological expertise for the development and commercialization of applied bio-mechanical technology. Facilitate the handoff/technology transfer of new commercial technology/devices to the Sales and Marketing, Field Service, and Manufacturing Departments. Qualifications •Minimum 4-year college degree with 3 – 5 years experience in microbiology, bioprocess engineering, embryology, hatchery automation, or related field preferred. Biological sciences degree with mechanical aptitude and experience preferred; engineering degree with strong biological aptitude and experience considered. •Experience conducting tests and protocols for product functionality, cleaning validation, durability testing, target animal safety and efficacy and product potency and purity. •Strong interpersonal and communication skills and ability to interact effectively with internal and external customers •Ability to manage multiple projects and function in an environment of changing priorities and directions

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