Senior Engineer

Overview

On Site
Full Time

Skills

Product Development
Aseptic Technique
GxP
Research

Job Details

Responsibilities:
  • 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.
  • In-depth 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.
Requirements:
  • 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.
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