Date: 29-May-2012
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Senior Process Development Engineer
* Maintain detailed documentation throughout all phases of research and development and prepare comprehensive reports
* Lead process design activities for new manufacturing concepts; coordinate external collaboration with vendors and outside resources to design and test concepts
* Lead project teams in the development, optimization, transfer and validation of processes from pilot scale to commercial scale; perform cost calculations to ensure new products will be cost effective in commercialization
* Develop detailed procedures for new processes and prepare appropriate specifications for materials, components and product testing
* Design, specify and test equipment required to manufacture product
In collaboration with Commerical Operations, recommend process improvements based on analysis of process data and scrap rates.
* Design and modify processes to cost effectively manufacture products which meet critical product attributes
* Perform experiments to screen critical process control factors
* Use experimental design techniques to develop robust processes at laboratory scale
* Through experiments, literature searches, internal and external interaction identify new technologies aimed at improving manufacturing efficiencies and product quality
* Other duties and projects as assigned
* Bachelors Degree in Chemical or Biochemical Engineering with a Masters Degree preferred
* Minimum of 5 years direct experience working with R&D to develop and transfer cost effective manufacturing processes into commercial production
* Knowledge of medical device manufacturing equipment (benchtop/pilot/commercial)process and systems, including aseptic processing and terminal sterilization techniques
* Knowledge of pharmaceutical/medical device packaging design, materials and equipment
* Knowledge of equipment fabrication techniques, cost estimation, and practical ability to review and create engineering drawings required
* Strong written and verbal communication skills; experience with Microsoft Office Suite
* Familiarity with AutoCAD, Solid works, Machine Vision Systems and Allen Bradley PLCs is desirable
* Project management and validation protocol writing and execution is required
To apply for this position, please visit
this Website.
Thank you,
BioTech FYI Center
http://biotech.fyicenter.com/
