An EB-2 National Interest Waiver petition for a computer systems reliability engineer in biopharmaceuticals was approved after a Request for Evidence (RFE). The main challenge was showing the scale of the future U.S. project: what benefit it would bring beyond a single company and why the applicant was capable of carrying it out. This case shows how such a petition is built and how to respond to an RFE.
Applicant profile and the petition’s basis
The applicant has over 10 years of international experience and a master’s degree in a biomedical field. The initial petition included educational grounds, qualifications equivalent to a U.S. degree (degree and its equivalent), and a project concept with substantial value to their work.
The preparation was built step by step: evidence of experience was gathered, already completed projects and achieved professional results were shown, and recommendations from industry experts were added.
The project: from consulting to a digital platform
The foundation of the future project is assisting several pharmaceutical manufacturers. It starts with consulting, followed by ready-made validation tools and a digital monitoring platform.
The main emphasis is that the applicant’s experience will help reduce the risk of production failures and support the stability of drug supply in the U.S. It was important to connect already completed successful projects with the future concept — that is, with the endeavor of substantial merit.
What was added in response to the Request for Evidence
Strengthening the petition after the RFE, based on the case description
- Processes, regulations, instructionsdeveloped by the applicant, documentary section expanded
- Confirmation of implementationinspection-preparation materials
- Letters of support and intentfrom independent experts and American organizations
- Explanation of independent workworking with several enterprises is broader than one position for one employer
Request for Evidence (RFE) and how it was answered
The petition was not approved right away, but only after an additional request. The main challenge was showing the scale of the future project: what benefit it would bring beyond a single company and why the applicant was capable of carrying it out.
In the response, concrete results were reinforced: processes, regulations, and instructions developed by the applicant were added, the documentary section was expanded, and confirmations of implementation and inspection-preparation materials were included.
U.S. interest was addressed separately. To this end, letters of support and intent were gathered from independent experts and American organizations, specifying concrete projects, areas of cooperation, and expected scope of work. It was also explained why independent work with several enterprises brings broader benefit than working a single position for one employer.
The applicant’s own role
The applicant took the preparation seriously: describing their projects in detail and gathering evidence of results. Their professional experience and involvement became an important part of the joint effort.
After the response to the additional request, the EB-2 NIW petition was approved. The applicant is now going through the stages of interview preparation, followed by visa issuance and entry into the U.S.
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