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 Posted: Thu Apr 05, 2007 8:37 pm Post subject: US-NY-Syracuse: ENGINEER SCIENTIST in biotech |
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To apply for this position, please visit this Website.
http://biotech.fyicenter.com/jobs/99896943_ENGINEER__SCIENTIST_in_biotech.html
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Date: 05-Apr-2007
ENGINEER SCIENTIST in biotech
Position Description and Responsibilities: The Technical Services
Engineer or Scientist will support the Operations group,Downstream
processing, cryogenics facility, facilities, materials management, on
a daily basis, as well as lead or contribute to strategic projects.
The successful candidate will author relevant sections of exception
documentation, Deviations, Failure Investigation, Environmental
Excursions, Calibration Alerts, and Maintenance Alerts, providing a
thorough root cause analysis, make a product impact assessment and
provide recommendations for suitable CAPA. Will identify opportunities
for process improvements, make formal recommendations and drive
improvements to completion. Review and evaluate product and process
impact of change controls. Support process validation, PV, studies by
providing input into PV protocols and on plant support for operations.
Collate data from manufacturing and perform statistical analysis to
trend and track process performance as well as identify opportunities
for process improvements. Author protocols and final technical reports
for specific studies required in Operations. Identify and assist in
the implementation of new technologies and procedures from Development
into Operations. Review manufacturing batch records, MBR, standard
operating procedures, SOP, and other cGMP documentation, as required.
Follow cGMP requirements. Position Requirements: The candidate will
have a B.Sc, B.Eng, M.Sc, M.Eng or Ph.D in Chemical Engineering or
Biochemical Engineering, Biological degree, i.e., Biochemistry,
Microbiology, or relevant Biotechnology course and relevant experience
in a cGMP biologics facility, R& D, technology transfer,
manufacturing. The candidate must have demonstrated verbal, written,
and communication skills and a successful proven history of working
with technical teams. Experience with manufacturing support or
technical transfer preferred, technical writing ability a must.
Thank you,
BioTech FYI Center
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