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US: Senior Process Development Engineer

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

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