Keywords: jobs

AMGEN is looking for Process Engineers to support commercial
biopharmaceutical manufacturing in Manufacturing Sciences and Technology
group. Process data mining, modeling, process chemometrics, batch modeling,
multivariate statistical batch SPC are among the skill set we desire to
support our exciting projects on Process Analytical Technology, continuous
process improvement and troubleshooting. Please find more detailed job
description below. Those who are interested may contact Dr. Cenk Undey
([log in to unmask], 401-392-8245).

Job Summary:
We are looking for an engineer/scientist to support commercial
biopharmaceutical manufacturing process troubleshooting and continuous
improvement efforts via advanced data mining, statistical modeling, and
multivariate data analysis. This role will also include supporting Process
Analytical Technologies (PAT) projects and working with analytical
scientists on the application of new measurement technologies in combination
with chemometrics analysis and modeling.

General responsibilities will include:
' Manufacturing support at Amgen's or contracted manufacturing sites for
' Process performance monitoring
' Development and/or use of process models (including input-output and first
principles models)
' Troubleshooting of manufacturing processes, and identification of process
improvement projects through advanced data analysis and statistical
' Provide input to corrective and preventive actions
' Support technology transfer of new processes across sites
' Support process data system improvement projects
' Perform individually or in teams; prioritize project tasks; handle
multiple projects and assignments simultaneously
BS or MS degree in Biochemical, Biomedical or Chemical Engineering, or
appropriate scientific field, or equivalent. At least 2 years of years
experience in biopharmaceutical or pharmaceutical industry. Advanced
education (e.g., Ph.D. or post-doctoral appointment) may be acceptable in
lieu of industry experience. The position title may be adjusted based on the
experience and expertise of the candidate.

Knowledge and skills required in one or more of the following areas:
Mammalian or bacterial cell culture, biopharmaceutical production processes
including bioreactors, and/or protein purification processes and systems
including chromatography, filtration and ultrafiltration 
Statistical analysis (of process data for process troubleshooting,
improvement and optimization studies), application of statistical principles
and probability theory
' Statistical Process Control (SPC)
' Data mining (statistical, parametric and non-parametric)
' Design of Experiments (DOE) and Optimization
' Experience with statistical and data analysis/modeling software tools such
as JMP, Spotfire, SIMCA and Matlab
The following skills are highly desirable:
Advanced applied statistics including multivariate analysis and
Process data management systems including process databases, automation
systems and process data historians.
Equipment, process and software validation and change control methodology
within a regulated manufacturing environment.
Experience with requirements specification development of software,
equipment and processes.

Excellent written and verbal communication is essential. Strong customer
orientation, collaboration and ability to lead/participate in teams are

Cenk Undey, Ph.D.
Senior Engineer
Amgen Inc.
Manufacturing Sciences and Technology
Process Engineering
40 Technology Way
West Greenwich, RI 02817
Phone: 401-392-8245  Fax: 401-392-3710