You must be enrolled in a relevant degree program, have a strong quality orientation, respect for individuals, integrity, problem-solving skills, and proficiency in Microsoft tools to excel in this internship.

You will support drafting and executing validation documentation, ensuring compliance with cGMP requirements for data integrity.

Engineering

United States

Durham

Large

KBI Biopharma is an award-winning biopharmaceutical contract services organization providing fully-integrated, accelerated drug development and biomanufacturing services to pharmaceutical and biotechnology companies globally.

With each of our 500+ client partners, we have worked closely to personalize and rapidly accelerate their drug development programs. Built upon a foundation of world-class analytical capabilities, we deliver efficient process development and clinical and commercial cGMP manufacturing services for mammalian, microbial, and cell therapy programs.

KBI is proud to be a JSR Life Sciences Company.

Science & Healthcare

KBI Biopharma

Research

<p>This position will provide validation support for at least one of the following areas:</p><ul><li>Facilities qualification</li><li>Utilities qualification</li><li>Equipment qualification</li><li>Manufacturing process control system qualification</li><li>Cleaning validation</li><li>Computer system validation</li><li>The incumbent will support data retrieval, compilation, verification, and comparative analysis from a variety of paper and electronic system formats. This will include authoring of studies, protocols, test scripts, and data tables to facilitate collection, expert data analysis/verification, summary reporting, and conclusions regarding acceptance criteria for validation studies conducted for the above-mentioned disciplines.</li><li>Intern may support operational efficiency projects.</li><li>Intern must have the ability to interface effectively with personnel across quality, engineering and other technical disciplines.</li><li>Intern must possess the ability to work as a member of a team to meet department needs and timelines.</li></ul>

Currently Studying

This position will provide validation support for at least one of the following areas:Facilities qualificationUtilities qualificationEquipment qualificationManufacturing process control system qualificationCleaning validationComputer system validationThe incumbent will support data retrieval, compilation, verification, and comparative analysis from a variety of paper and electronic system formats. This will include authoring of studies, protocols, test scripts, and data tables to facilitate collection, expert data analysis/verification, summary reporting, and conclusions regarding acceptance criteria for validation studies conducted for the above-mentioned disciplines.Intern may support operational efficiency projects.Intern must have the ability to interface effectively with personnel across quality, engineering and other technical disciplines.Intern must possess the ability to work as a member of a team to meet department needs and timelines.

Validation Engineer Intern

Requirements

Responsibilities

KBI Biopharma

Mission & Purpose