US-NorthCarolina-Durham: Bio Integration Specialist
http://biotech.fyicenter.com
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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
Thank you,
BioTech FYI Center
http://biotech.fyicenter.com/