STEM OPT Process Development Engineer Jobs
Process Development Engineer roles qualify for the STEM OPT 24-month extension if your degree falls under an eligible CIP code in engineering or a related STEM field. Your employer must be enrolled in E-Verify, and you'll need an approved I-983 training plan before your extension begins.
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Position Summary:
The Downstream Process Development Associate II supports and executes laboratory studies within the KBI Biopharma (KBI) Downstream Process Development organization under general supervision.
Position Responsibilities:
- Conducts laboratory experiments in support of downstream/drug substance process development including preparing solutions, running downstream unit operations (chromatography, tangential flow filtration, clarification, normal filtration, etc.), sampling and executing basic analysis of process samples (concentration, pH, conductivity, etc.).
- Exercises judgment within defined procedures and practices to determine appropriate action (sometimes called upon to exercise judgment outside of defined procedures).
- Observes and analyzes data resulting from executed experiments; identifies and troubleshoots unexpected results with input and/or review from peers or management.
- Compiles data and contributes to drafting of templated technical documents. May contribute to client presentation development and may interact with clients.
- May contribute to the evaluation, development and implementation of new downstream technologies leading to process improvements and efficiency of operation in support of downstream process development and manufacturing activities.
- Documents procedures, observations, and results in laboratory notebooks and responsible for maintaining training compliance, according to site expectation. Reviews documentation and records as assigned.
- Contributes to general lab maintenance and operation excellence initiatives in accordance with internal guidance. Assures proper labeling, handling, and storage of all chemicals used in the area; assures proper labeling and disposition of hazardous waste in satellite areas; adheres to all safety requirements and follows safe procedures, and attends all required safety and health training, including handling hazardous waste.
- Reacts to change productively and handles other essential tasks as assigned.
Minimum Requirements:
Process Development Associate II requires a B.S. degree and 2+ years experience or a M.S. degree.
Excellent written and verbal communication skills, focus on customer service, and ability to meet strict client deadlines. Flexibility of hours to support downstream processes. Knowledge of GMPs and biotechnology-derived product regulations preferred.
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.
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Get Access To All JobsTips for Finding STEM OPT Authorization as a Process Development Engineer
Verify your CIP code before applying
Check that your degree's Classification of Instructional Programs code appears on the DHS STEM OPT eligible fields list. Chemical engineering, materials science, and bioengineering codes all qualify for Process Development Engineer roles, but adjacent degrees like applied chemistry may require confirmation from your DSO.
Build an I-983 training plan around process milestones
Write your training objectives around specific deliverables in scale-up, validation, or manufacturing process design, not generic engineering tasks. Employers reviewing your I-983 need to see measurable learning goals tied to your actual role, or USCIS may issue a request for evidence.
Target employers who already file LCAs for engineers
Search the OFLC Wage Search to identify companies that have certified Labor Condition Applications for Process Engineer or Process Development titles. Repeat LCA filers in pharma, semiconductors, and specialty chemicals are already familiar with STEM OPT compliance requirements.
Confirm E-Verify enrollment before accepting any offer
Ask your recruiter to confirm E-Verify company ID or check the employer's status directly through the E-Verify employer search. An employer that isn't enrolled cannot legally employ you on a STEM OPT extension, regardless of how far you are in the offer process.
Use Migrate Mate to filter roles by E-Verify status
Search Process Development Engineer openings on Migrate Mate, which surfaces employers verified for STEM OPT hiring so you don't spend time applying to companies that can't support your extension. Filter by industry to focus on biotech, pharma, or semiconductor manufacturing.
Start cap-gap planning before your OPT expires
If your employer files an H-1B visa petition on your behalf before your OPT end date and you're selected in the lottery, cap-gap automatically extends your work authorization through September 30. Confirm your employer's H-1B filing calendar during the offer stage, not after your EAD runs out.
Frequently Asked Questions
Does a Process Development Engineer role qualify for the STEM OPT extension?
Yes, if your degree is in an eligible STEM field such as chemical engineering, materials science, biomedical engineering, or a related discipline with a qualifying CIP code. The role itself must also provide practical training directly related to your degree. Your DSO confirms eligibility and updates your I-20 before USCIS approves the extension.
What goes into the I-983 training plan for a Process Development Engineer?
Your I-983 must list specific learning objectives tied to your day-to-day engineering work, such as process scale-up, design of experiments, or validation protocol development. Vague goals like 'gain industry experience' are insufficient. Both you and your employer's authorized representative sign the form, and your DSO must receive it before your extension start date.
How do I verify that my employer is enrolled in E-Verify?
You can confirm enrollment through the E-Verify employer search tool, which lets you look up companies by name or employer identification number. Ask your recruiter for the company's E-Verify ID during the offer stage. Employers in federal contracting or operating in certain states may be required to enroll, but many smaller manufacturers are not and may need to register before hiring you.
What happens to my STEM OPT authorization if my employer changes the role after I start?
A material change in job duties, location, or employer requires an amended I-983 submitted to your DSO within five days. If you move to a different legal entity, such as a subsidiary or acquired company, that entity must also be enrolled in E-Verify. Failing to update your training plan puts your STEM OPT status at risk, so notify your DSO promptly when any significant change occurs.
Where can I find Process Development Engineer jobs that are open to STEM OPT students?
Migrate Mate lists Process Development Engineer openings from employers with verified E-Verify enrollment, so you can focus on roles where your STEM OPT extension is actually supported. You can also cross-reference the O*NET profile for this occupation to confirm that job descriptions align with your degree field before you apply.