Senior Engineer
Senior Engineer
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
- Under direction of supervisor or the sterility assurance focal point contributes to the design development or enhancement of new products and processes.
- Effectively contribute solid technical knowledge to a variety of projects within the sterility assurance discipline with minimal assistance.
- Display basic technical understanding of related sterility assurance disciplines specifically sterilization modalities.
- Utilize engineering tools to solve straightforward problems.
- With minimal assistance perform standard engineering assignments and provide sound. technical recommendations regarding projects/matters that are more routine than not.
- Independently execute routine assignments within negotiated deadlines.
- Indepth knowledge and understanding of GxP and related regulations and guidance.
- Provide support to the Sterility Assurance Focal Point for product development or on change controls.
- Write execute and review validation and qualification protocols and reports.
- Evaluate and interpret technical data and test results.
- Display a solid technical understanding of engineering principles and procedures.
- Demonstrate application of engineering principles on individual/small projects.
- B.S. in Engineering and 3 5 years related experience.
- Understanding of aseptic technique (RAII).
- Ability to conduct experiments with minimal assistance.
- Knowledge and understanding of GxP and related regulations and guidance.
- Must have Basic technical understanding of sterilization (Moist Heat Aseptic Irradiation).
- Must have Basic technical understanding of microbiological method validations (sterility.
- Must have bioburden and bacterial endotoxin) (specific for the Research Associate II).
- Must have the Ability to write execute and review validation and qualification protocols and reports.
- Must have the Ability to Evaluate and interpret technical data and test results.
Employment Type
Full Time
