Manufacturing Engineer II
Job Location : Woodinville, WA US
Tracking Code : R12-007
Job Description
The focus of this position is the transfer of new assays from R&D to commercial manufacturing and implementation of process improvements for existing product lines. Responsible for process scale-up and transfer projects related to BioPlex 2200 in vitro diagnostic immunoassays. Write, execute, and report validation studies in a timely manner. Maintain organized records of results. Create and maintain risk assessments and validation plans. Coordinate the manufacture and testing of validation/clinical lot builds. Draft manufacturing and testing procedures. Must have capacity to review, analyze, and summarize data in a concise, scientific manner. Knowledge of bioconjugation chemistry desired. Good group communication and planning skills are needed, in addition to the ability to work with a team in a highly technical environment. Must be able to interface with individuals from different departments/disciplines to complete projects and summarize activities.
Required Skills
Bachelor’s degree in a life or physical science or a related engineering discipline desired. Advanced degree preferred. Knowledge and experience with bioconjugation and protein purification techniques is desired. Advanced to expert level Microsoft Excel skills are required; strong expertise with Excel formulas, macros, graphing, and formatting is preferred. Six Sigma Green Belt certified desired. Excellent written and verbal communication, interpersonal, presentation, project management, and organizational skills are required.
Required Experience
Minimum of two years experience in a manufacturing/development environment where typical duties include performing engineering activities such as validation study design/execution, risk assessment, failure investigations, process development, and product transfer. Experience working under cGMP, FDA regulations and ISO standards, and with the development, manufacture or support of in vitro diagnostic or biological products is highly desirable. Knowledge and experience with bioconjugation and protein purification techniques is desired. Experience in writing, executing, and reporting validation studies related to processes and test methods is required. Experience with FMEA, process risk assessment, and technical skills encompassing investigation and troubleshooting desired.
If you fit the above criteria please submit your application along with your CV, academic transcripts, recent photo and references to our email address provided below
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The focus of this position is the transfer of new assays from R&D to commercial manufacturing and implementation of process improvements for existing product lines. Responsible for process scale-up and transfer projects related to BioPlex 2200 in vitro diagnostic immunoassays. Write, execute, and report validation studies in a timely manner. Maintain organized records of results. Create and maintain risk assessments and validation plans. Coordinate the manufacture and testing of validation/clinical lot builds. Draft manufacturing and testing procedures. Must have capacity to review, analyze, and summarize data in a concise, scientific manner. Knowledge of bioconjugation chemistry desired. Good group communication and planning skills are needed, in addition to the ability to work with a team in a highly technical environment. Must be able to interface with individuals from different departments/disciplines to complete projects and summarize activities.
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