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.

• 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