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Internship

Validation Engineer Intern

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KBI Biopharma

•

1mo ago

🚀 Off-cycle Internship

Durham

AI generated summary

  • 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.

Off-cycle Internship

Engineering•Durham

Description

This position will provide validation support for at least one of the following areas:

  • Facilities qualification
  • Utilities qualification
  • Equipment qualification
  • Manufacturing process control system qualification
  • Cleaning validation
  • Computer system validation
  • 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.
  • 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.

Requirements

  • High school diploma; currently enrolled in a 4-year degree program in a scientific, engineering, biochemical engineering, or related discipline
  • A demonstrated track record in the following key areas:
  • Strong orientation for quality and customer service
  • Demonstrated level of respect for individuals
  • High level of integrity and personal responsibility
  • Ability to read and comprehend instructions, correspondence, and memos. Ability to write routine correspondence. Ability to respond to common inquiries from employees.
  • Ability to manage and prioritize multiple efforts independently. Ability to write, follow, issue and explain clear instructions furnished in written and oral form.
  • Ability to methodically solve problems to their root causes.
  • Ability to walk job sites, climb ladders, lift small equipment and tools.
  • Able to proficiently use Microsoft Word, Excel, Outlook, Teams, etc.

Education requirements

Currently Studying

Area of Responsibilities

Engineering

Responsibilities

  • Support drafting and execution of validation documentation
  • Conform to all cGMP requirements for documentation and data integrity

Details

Work type

Full time

Work mode

office

Location

Durham