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Internship

Manufacturing Compliance Intern

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KBI Biopharma

27d ago

🚀 Off-cycle Internship

Durham

AI generated summary

  • Enrolled in engineering or life sciences Bachelor's program; able to read and interpret English documents related to safety rules, SOPs, and production records.
  • The candidate will support batch data analysis, deviation investigations, CAPA implementations, and Operational Excellence initiatives in cGMP production runs. They will apply engineering principles to drive projects to completion, manage multiple projects, and support process data analysis for project meetings.

Off-cycle Internship

EngineeringDurham

Description

  • The Manufacturing Compliance Intern will apply scientific principles to support batch report generation, manufacturing record review, and manufacturing improvement projects including CAPAs and manufacturing document revisions. This role will provide exposure to biopharmaceutical manufacturing operations in a cGMP manufacturing facility which also includes pre-quality review and material usage reconciliation.  

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

Education requirements

Currently Studying

Area of Responsibilities

Engineering

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.

Details

Work type

Full time

Work mode

office

Location

Durham