Position Summary

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.

Position Responsibilities

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

Position 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.

Salary: $15-$20/hour

KBI Biopharma is committed to providing a safe and healthy workplace. Any employee entering a KBI site located in the US must inform KBI Biopharma of their vaccination status and must submit their vaccination status. All vaccinated employees are required to provide proof of their COVID-19 vaccination, with a COVID-19 vaccination which has been granted FDA approval or Emergency Use Authorization.

KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply.

I understand that neither the completion of this application nor any other part of my consideration for employment establishes any obligation for KBI Biopharma, Inc. to hire me. If I am hired, I understand that either KBI Biopharma, Inc. or I can terminate my employment at any time and for any reason, with or without cause and without prior notice. I understand that no representative of KBI Biopharma, Inc. has the authority to make any assurance to the contrary.

I attest with my signature below that I have given to KBI Biopharma, Inc. true and complete information on this application. No requested information has been concealed. I authorize KBI Biopharma, Inc. to contact references provided for employment reference checks. If any information I have provided is untrue, or if I have concealed material information, I understand that this will constitute cause for the denial of employment or immediate dismissal.