Manufacturing Compliance Intern

KBI Biopharma

Mar 20

Applications are closed

Internship
Full-time
Off-cycle Internship
Engineering
Durham

Requirements

High school degree or equivalent, and is currently enrolled in a Bachelor’s degree program in engineering or life sciences program, or equivalent.
Ability to read and interpret English documents such as safety rules, SOPs, and batch and production records

Responsibilities

Supporting the preparation of batch trends and reports as required. This will include reports for the process monitoring of upstream cell culture, harvest, and downstream purification operations. Compiling and analyzing process data to identify process excursions and entering appropriate comments in the electronic batch records.
This includes supporting deviation investigations and CAPA implementations as needed.
Supporting Operational Excellence initiatives in support of cGMP production runs. This includes review of ongoing operations, determining opportunities for improvement, and implementing solutions. This may also include supporting 5S implementation activities.
The candidate should be able to apply engineering principles in order to problem-solve and drive assigned projects to successful completion within defined timelines. The ability to manage multiple projects and resources is required.
Supporting Operational Excellence initiatives in support of cGMP production runs. This includes review of executed batch operations and determining opportunities for improvement.
Training on KBI Standard Operating Procedures
Collect, organize, and analyze process data from engineering and manufacturing runs for presentation at project meetings if needed.

KBI Biopharma

Science Driven. Customer Centric.

Science & Healthcare

Industry

1001-5000

Employees

1996

Founded Year

Mission & Purpose

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.