E-3 Visa Process Development Engineer Jobs
Process Development Engineer roles in biotech, semiconductors, and advanced manufacturing are strong fits for E-3 visa sponsorship. Australian engineers with a bachelor's in chemical, materials, or process engineering qualify as specialty occupation workers, and the E-3's no-lottery structure means you can start within weeks of receiving a job offer.
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Get Access To All JobsINTRODUCTION
At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.
Overview
At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.
We are seeking a highly motivated candidate for the position of Director/Sr. Director, Late-Stage LNP Process Development. The individual will partner with the following teams - Early-Stage LNP, Tech Transfer and Manufacturing, LNP Platform Innovation, Analytical Development - as well as the broader Delivery Devices and Connected Solutions team, and cross functionally with Bioproduct Research and Development to advance Lilly’s transformative pipeline. The successful candidate will combine deep scientific expertise, operational excellence, and a passion for tackling new challenges in a fast-paced, dynamic environment.
KEY RESPONSIBILITIES
- Establish the technical roadmap for the Late-Stage LNP Process Development team.
- Drive the process development, optimization, scale-up, process characterization, and process understanding activities for the late-stage LNP Drug Product programs.
- Partner with the Early-Stage LNP Process Development and Analytical Development teams to develop the scale up and comparability strategy and mitigate risks during scale-up.
- Develop Phase 3 ready manufacturing processes and partner with the Tech Transfer and Manufacturing team to transfer the process to late-stage internal and external manufacturing partners for Phase 3 and commercialization.
- Establish and execute process characterization strategies and activities to prepare for commercial process lock.
- Define product/product requirements and capacity needs for the Phase 3 and commercial processes and assist in the selection of the Phase 3/commercial manufacturing site.
- Lead development, optimization, and pre-qualification of analytical methods; and build characterization, release, stability, and comparability testing programs across drug substance, process, formulation, and finished product.
- Drive innovative process solutions for robust production of RNA-LNP products including tLNP.
- Author and review technical reports and relevant sections of regulatory submissions, and participate in regulatory interactions as needed.
- Identify external collaborations to enhance internal capabilities and drive process innovation, and represent the company at scientific meetings and industry forums.
BASIC QUALIFICATIONS
- PhD in engineering, chemistry, molecular biology, or a related field with 10+ years of relevant industry experience.
- Demonstrated experience in RNA-LNP process development, scale-up, and tech transfer.
- Proven experience in phase-appropriate assay development, optimization, qualification, and transfer for lot release, stability, and product characterization from early through late-stage development.
- Solid understanding of ICH guidelines and industry best practices for cell and gene therapies.
- Excellent problem-solving skills with the ability to influence scientific direction and drive scientific excellence across stakeholders.
PREFERRED QUALIFICATIONS
- Experience advancing complex parenteral products from clinical to BLA/NDA regulatory submission is highly preferred.
- Prior experience authoring regulatory submission documents and supporting health authority interactions.
- Sound understanding of statistics and data management.
ADDITIONAL INFORMATION
Physical Demands/Travel
The physical demands of this job are consistent with a lab environment. The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
Work Environment
This position’s work environment is in a laboratory environment. The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.
To perform this job successfully, an individual must be able to perform the role and responsibilities satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).
COMPENSATION
Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $168,000 - $246,400.
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities). Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
INTRODUCTION
At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.
Overview
At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.
We are seeking a highly motivated candidate for the position of Director/Sr. Director, Late-Stage LNP Process Development. The individual will partner with the following teams - Early-Stage LNP, Tech Transfer and Manufacturing, LNP Platform Innovation, Analytical Development - as well as the broader Delivery Devices and Connected Solutions team, and cross functionally with Bioproduct Research and Development to advance Lilly’s transformative pipeline. The successful candidate will combine deep scientific expertise, operational excellence, and a passion for tackling new challenges in a fast-paced, dynamic environment.
KEY RESPONSIBILITIES
- Establish the technical roadmap for the Late-Stage LNP Process Development team.
- Drive the process development, optimization, scale-up, process characterization, and process understanding activities for the late-stage LNP Drug Product programs.
- Partner with the Early-Stage LNP Process Development and Analytical Development teams to develop the scale up and comparability strategy and mitigate risks during scale-up.
- Develop Phase 3 ready manufacturing processes and partner with the Tech Transfer and Manufacturing team to transfer the process to late-stage internal and external manufacturing partners for Phase 3 and commercialization.
- Establish and execute process characterization strategies and activities to prepare for commercial process lock.
- Define product/product requirements and capacity needs for the Phase 3 and commercial processes and assist in the selection of the Phase 3/commercial manufacturing site.
- Lead development, optimization, and pre-qualification of analytical methods; and build characterization, release, stability, and comparability testing programs across drug substance, process, formulation, and finished product.
- Drive innovative process solutions for robust production of RNA-LNP products including tLNP.
- Author and review technical reports and relevant sections of regulatory submissions, and participate in regulatory interactions as needed.
- Identify external collaborations to enhance internal capabilities and drive process innovation, and represent the company at scientific meetings and industry forums.
BASIC QUALIFICATIONS
- PhD in engineering, chemistry, molecular biology, or a related field with 10+ years of relevant industry experience.
- Demonstrated experience in RNA-LNP process development, scale-up, and tech transfer.
- Proven experience in phase-appropriate assay development, optimization, qualification, and transfer for lot release, stability, and product characterization from early through late-stage development.
- Solid understanding of ICH guidelines and industry best practices for cell and gene therapies.
- Excellent problem-solving skills with the ability to influence scientific direction and drive scientific excellence across stakeholders.
PREFERRED QUALIFICATIONS
- Experience advancing complex parenteral products from clinical to BLA/NDA regulatory submission is highly preferred.
- Prior experience authoring regulatory submission documents and supporting health authority interactions.
- Sound understanding of statistics and data management.
ADDITIONAL INFORMATION
Physical Demands/Travel
The physical demands of this job are consistent with a lab environment. The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
Work Environment
This position’s work environment is in a laboratory environment. The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.
To perform this job successfully, an individual must be able to perform the role and responsibilities satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).
COMPENSATION
Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $168,000 - $246,400.
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities). Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
See all E-3 Visa Process Development Engineer Jobs
Sign up for free to unlock all listings, filter by visa type, and get alerts for new E-3 Visa Process Development Engineer Jobs.
Get Access To All JobsTips for Finding E-3 Visa Sponsorship as a Process Development Engineer
Frame your credentials for U.S. specialty occupation
Australian three-year engineering degrees meet the E-3 visa specialty occupation standard, but your offer letter must tie your specific degree field directly to the role. Ask your employer to specify 'chemical engineering' or 'materials science' rather than a generic engineering title.
Target industries with established LCA filing history
Pharmaceutical manufacturers, semiconductor fabs, and contract development and manufacturing organizations regularly file Labor Condition Applications for process roles. Searching DOL's Foreign Labor Application Gateway by SOC code 17-2041 surfaces which employers have sponsored this role before.
Raise E-3 early in the offer conversation
Many U.S. hiring managers conflate E-3 with H-1B visa and assume a lottery is involved. Clarifying that your E-3 sponsorship requires no lottery, no cap, and a DOL-certified LCA often removes the main objection before it becomes a blocker.
Align your start date with LCA certification timelines
DOL typically certifies an LCA within seven business days, but your employer should file before you schedule your consulate appointment. Build at least two weeks of buffer into your proposed start date so the certified LCA is in hand before your interview.
Use Migrate Mate's E-3 filing service for the LCA and consulate prep
Process engineers changing employers mid-project often face tight timelines. Migrate Mate's E-3 filing service manages the LCA submission, visa paperwork, and consulate preparation end-to-end, which reduces the administrative load on your new employer and keeps the process moving.
Prepare a degree equivalency letter if your major is adjacent
If your degree is in a related field such as biotechnology or mechatronics rather than chemical or industrial engineering, obtain a credential evaluation from a USCIS-recognized evaluator before your interview. Consular officers can and do question degree-to-role fit on technical specialty occupation cases.
E-3 Visa Process Development Engineer: Frequently Asked Questions
How do I find Process Development Engineer jobs with E-3 sponsorship?
Migrate Mate lists Process Development Engineer roles from employers who have already sponsored E-3 and H-1B visas, so you're not guessing at sponsorship willingness. Filter by role and visa type to surface active openings. Standard job platforms don't filter by sponsorship history, which means you waste time applying to employers who won't sponsor an Australian engineer on an E-3.
How much does it cost to get an E-3 visa?
Migrate Mate's E-3 filing service covers the entire process for $499, including the Labor Condition Application, visa document preparation, and consulate appointment guidance. Traditional immigration lawyers charge $2,000–$5,000+ for the same work. The E-3 has less paperwork than most work visas, so paying thousands for legal help is usually unnecessary.
Does a Process Development Engineer role qualify as a specialty occupation for the E-3?
Yes, provided the position requires a bachelor's degree or higher in a specific technical field such as chemical engineering, materials science, or biomedical engineering. Generic engineering roles where any bachelor's degree suffices can fail the specialty occupation test. Your employer's job description and offer letter should specify the required degree field explicitly to support the LCA and visa application.
How does the E-3 visa compare to the H-1B for a Process Development Engineer role?
Both visas require the role to qualify as a specialty occupation, and both require a DOL-certified LCA. The practical difference is significant: the H-1B is subject to an annual lottery with roughly a 25% selection rate, while the E-3 has no lottery and no cap. An Australian process engineer can receive an offer, complete the LCA, and attend a consulate appointment within four to six weeks. The H-1B path typically takes six months or longer from registration to start date.
Can I switch process engineering employers while on an E-3?
Yes, but you can't port your existing E-3 the way an H-1B holder can under portability rules. Your new employer files a fresh LCA, and you apply for a new E-3 at a U.S. consulate or embassy. There's no grace period that allows you to remain in status between jobs, so time the transition carefully and have the new LCA certified before your current role ends.