Medical Devices Green Card Sponsorship Jobs in North Carolina
North Carolina's medical devices sector spans Research Triangle Park, the Charlotte metro, and the Triad region, home to employers like Becton Dickinson, Teleflex, and Siemens Healthineers. Companies in this concentrated industry cluster actively sponsor Green Cards for engineers, regulatory specialists, and clinical professionals seeking long-term careers in the state.
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Welcome to Holly Springs, North Carolina— home to Genentech's largest-ever investment with an ambitious goal to be a fully connected Plant of the Future. This is where next-generation technology, capability, digital connectivity and Operational Excellence converge to create the global standard for high-volume, highly-efficient Drug Product manufacturing. This will include Component Prep & Compounding, Liquid PFS Filling, Automated Inspection, Autoinjector Assembly, Packaging/Finished Products.
The facility's core is defined by innovation - leveraging advanced automation, robotics, digital tools, real-time data analytics, and simple, streamlined processes to produce the highest quality medicines. This plant will not only meet today’s demand for CVRM (Cardiovascular, Renal, and Metabolism) medicines but is a strategic commitment to be scalable with this portfolio, which serves one of the largest patient populations in the world. This is a fast-paced, highly entrepreneurial environment with a high-level of accountability from the site team to launch operations in 2028.
Are you a problem-solver and change agent who thrives in a High-Performing Team environment, eager to tackle the most complex manufacturing challenges? If so, this is a once-in-a-lifetime opportunity to not only launch a state-of-the-art facility from the ground-up but to shape the culture of our organization for the next generation.
Join us in Holly Springs, where you won't just build a plant—you will build the future of medicine.
The Opportunity:
Reporting to the Head of Validation, the Principal/Senior Principal Validation Engineer serves as the primary technical expert for establishing and executing validation strategies across high-speed pre-filled syringe (PFS) assembly, labeling, traying, automated cartoning, case packing, and associated facilities and utilities.
In this strategic, high-impact role, you will define, execute, and maintain the lifecycle validation strategy (IQ/OQ/PQ/PPQ as applicable) for combination product assembly and packaging lines, supporting facilities, and utilities—particularly in support of a new greenfield facility setup. You will bridge technical engineering, quality assurance, automation, and regulatory affairs to ensure manufacturing assets achieve peak operational readiness and strictly align with global combination product expectations (FDA 21 CFR Part 4 / Part 820, ISO 11607, EU Annex 1/15).
- You will establish, maintain, and own the Validation Master Plan (VMP) for high-speed PFS assembly, packing lines, and associated facilities/utilities lines as applicable.
- You will author, review, and execute PQ and PPQ protocols, sampling plan and summary reports associated with assembly and packaging lines, supporting utilities and facilities.
- You will contribute expertise in project management, technical design, testing, qualification, recipe development and validation to ensure successful installation, qualification and validation of the assembly/pack and visual inspection program.
- You will provide oversight of validation change control management, deviation management, risk management for validated equipment, utilities, processes and facilities supporting assembly and packaging lines.
- You will review and approve change controls (CRs), engineering specifications, and impact assessments for existing equipment modifications. You will perform appropriate qualifications as needed for change controls including authoring any documentations, executions of studies and summary report to close change controls.
- You will provide technical leadership and mentorship to junior validation engineers, project teams, and external contractors.
- You will lead validation deliverables for New Product Introductions (NPI), capital expansions, and drug-device combination product technology transfers.
- You will collaborate seamlessly across multi-disciplinary teams, including Process Development, Operations, Quality Assurance, Automation Engineering, and Maintenance.
- You will incorporate new regulations into manufacturing processes and validation programs ensuring continued compliance.
- You will prepare, review and approve relevant sections of regulatory submissions.
- You will lead the presentation of the validation program and maintenance of the validated state during periodic audits and regulatory inspections.
- Support and lead other validation activities as needed for the success of the new green field site. Including any equipment qualifications, temperature mapping or partnering with contract organizations.
Who you are:
- You have a BS/MS in chemical, biochemical engineering, or related field/experience, with a minimum of 5-7 years (Principal) and 8-11 years (Senior Principal) experience in drug product fill finish/packaging, Engineering, Manufacturing, or Technical Services.
- You have experience in the pharma/biotech industry.
- You have hands-on experience in the design, selection, installation, and validation of equipment used in assembly and packaging of autoinjectors or pen lines.
- You have knowledge of cGMPs or equivalent regulations, experience working in a regulated environment, and a strong understanding of the regulatory requirements.
- You have working knowledge of visual inspections, assembly, and packaging, equipment qualification in a regulated environment.
- You have experience in managing equipment and process related projects, including commissioning and qualification, performance qualifications, PPQs, new product introduction, and technology transfers.
- You have demonstrated experience in writing and reviewing SOPs, sampling plans, protocols and reports for traceability, and compliance.
- You have experience in performing and leading validation studies within the pharmaceutical and biotechnology industry.
- You have experience working collaboratively with cross-functional teams, including development, operations, quality assurance, automation engineering, and maintenance.
- You have experience in driving continuous improvement initiatives related to process, equipment, and quality systems.
- You have demonstrated project management skills.
- You have operational excellence and industrial engineering skills.
- You have professional level written and oral communication skills.
This role will require full onsite work at the project office before transition to the site offices once complete.
The expected salary range for this position in Holly Springs, NC is $95,000 - $176,000 (Principal) or $114,400 - $212,400 (Senior Principal). Actual pay will be determined based on experience, level, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance.
Relocation benefits are provided.
Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.
If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.
JOB FACTS
-
Job Sub Category
Process Development
-
Schedule
Full time
-
Job Type
Regular
-
Posted Date
Sep 10th 2026
-
Job ID
202609-123314
The Position
Welcome to Holly Springs, North Carolina— home to Genentech's largest-ever investment with an ambitious goal to be a fully connected Plant of the Future. This is where next-generation technology, capability, digital connectivity and Operational Excellence converge to create the global standard for high-volume, highly-efficient Drug Product manufacturing. This will include Component Prep & Compounding, Liquid PFS Filling, Automated Inspection, Autoinjector Assembly, Packaging/Finished Products.
The facility's core is defined by innovation - leveraging advanced automation, robotics, digital tools, real-time data analytics, and simple, streamlined processes to produce the highest quality medicines. This plant will not only meet today’s demand for CVRM (Cardiovascular, Renal, and Metabolism) medicines but is a strategic commitment to be scalable with this portfolio, which serves one of the largest patient populations in the world. This is a fast-paced, highly entrepreneurial environment with a high-level of accountability from the site team to launch operations in 2028.
Are you a problem-solver and change agent who thrives in a High-Performing Team environment, eager to tackle the most complex manufacturing challenges? If so, this is a once-in-a-lifetime opportunity to not only launch a state-of-the-art facility from the ground-up but to shape the culture of our organization for the next generation.
Join us in Holly Springs, where you won't just build a plant—you will build the future of medicine.
The Opportunity:
Reporting to the Head of Validation, the Principal/Senior Principal Validation Engineer serves as the primary technical expert for establishing and executing validation strategies across high-speed pre-filled syringe (PFS) assembly, labeling, traying, automated cartoning, case packing, and associated facilities and utilities.
In this strategic, high-impact role, you will define, execute, and maintain the lifecycle validation strategy (IQ/OQ/PQ/PPQ as applicable) for combination product assembly and packaging lines, supporting facilities, and utilities—particularly in support of a new greenfield facility setup. You will bridge technical engineering, quality assurance, automation, and regulatory affairs to ensure manufacturing assets achieve peak operational readiness and strictly align with global combination product expectations (FDA 21 CFR Part 4 / Part 820, ISO 11607, EU Annex 1/15).
- You will establish, maintain, and own the Validation Master Plan (VMP) for high-speed PFS assembly, packing lines, and associated facilities/utilities lines as applicable.
- You will author, review, and execute PQ and PPQ protocols, sampling plan and summary reports associated with assembly and packaging lines, supporting utilities and facilities.
- You will contribute expertise in project management, technical design, testing, qualification, recipe development and validation to ensure successful installation, qualification and validation of the assembly/pack and visual inspection program.
- You will provide oversight of validation change control management, deviation management, risk management for validated equipment, utilities, processes and facilities supporting assembly and packaging lines.
- You will review and approve change controls (CRs), engineering specifications, and impact assessments for existing equipment modifications. You will perform appropriate qualifications as needed for change controls including authoring any documentations, executions of studies and summary report to close change controls.
- You will provide technical leadership and mentorship to junior validation engineers, project teams, and external contractors.
- You will lead validation deliverables for New Product Introductions (NPI), capital expansions, and drug-device combination product technology transfers.
- You will collaborate seamlessly across multi-disciplinary teams, including Process Development, Operations, Quality Assurance, Automation Engineering, and Maintenance.
- You will incorporate new regulations into manufacturing processes and validation programs ensuring continued compliance.
- You will prepare, review and approve relevant sections of regulatory submissions.
- You will lead the presentation of the validation program and maintenance of the validated state during periodic audits and regulatory inspections.
- Support and lead other validation activities as needed for the success of the new green field site. Including any equipment qualifications, temperature mapping or partnering with contract organizations.
Who you are:
- You have a BS/MS in chemical, biochemical engineering, or related field/experience, with a minimum of 5-7 years (Principal) and 8-11 years (Senior Principal) experience in drug product fill finish/packaging, Engineering, Manufacturing, or Technical Services.
- You have experience in the pharma/biotech industry.
- You have hands-on experience in the design, selection, installation, and validation of equipment used in assembly and packaging of autoinjectors or pen lines.
- You have knowledge of cGMPs or equivalent regulations, experience working in a regulated environment, and a strong understanding of the regulatory requirements.
- You have working knowledge of visual inspections, assembly, and packaging, equipment qualification in a regulated environment.
- You have experience in managing equipment and process related projects, including commissioning and qualification, performance qualifications, PPQs, new product introduction, and technology transfers.
- You have demonstrated experience in writing and reviewing SOPs, sampling plans, protocols and reports for traceability, and compliance.
- You have experience in performing and leading validation studies within the pharmaceutical and biotechnology industry.
- You have experience working collaboratively with cross-functional teams, including development, operations, quality assurance, automation engineering, and maintenance.
- You have experience in driving continuous improvement initiatives related to process, equipment, and quality systems.
- You have demonstrated project management skills.
- You have operational excellence and industrial engineering skills.
- You have professional level written and oral communication skills.
This role will require full onsite work at the project office before transition to the site offices once complete.
The expected salary range for this position in Holly Springs, NC is $95,000 - $176,000 (Principal) or $114,400 - $212,400 (Senior Principal). Actual pay will be determined based on experience, level, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance.
Relocation benefits are provided.
Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.
If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.
JOB FACTS
-
Job Sub Category
Process Development
-
Schedule
Full time
-
Job Type
Regular
-
Posted Date
Sep 10th 2026
-
Job ID
202609-123314
Green Card Medical Devices Job Roles in North Carolina
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Search Medical Devices Jobs in North CarolinaMedical Devices Green Card Sponsorship Jobs in North Carolina: Frequently Asked Questions
Which medical devices companies sponsor Green Card visas in North Carolina?
Several major medical devices employers in North Carolina have established histories of Green Card sponsorship, including Becton Dickinson, Teleflex, Siemens Healthineers, and Hologic. Research Triangle Park hosts a number of mid-size and global medtech firms that file PERM labor certifications regularly for engineering, quality, regulatory, and R&D roles. Sponsorship patterns vary by role, team, and hiring cycle, so it is worth researching specific employers through DOL PERM disclosure data.
Which cities in North Carolina have the most medical devices Green Card sponsorship jobs?
The Research Triangle area, covering Raleigh, Durham, and Chapel Hill, concentrates the largest share of medical devices sponsorship activity in North Carolina, partly due to its proximity to major research universities and a dense medtech employer base. Charlotte is the second most active market, with growing presence in diagnostics and medical equipment. Greensboro and the broader Triad region also host established manufacturing and quality operations for several device companies.
What types of medical devices roles typically qualify for Green Card sponsorship in North Carolina?
Roles most commonly sponsored in North Carolina's medical devices sector include regulatory affairs specialists, R&D engineers, quality engineers, software engineers working on medical software, manufacturing engineers, and clinical applications specialists. These positions generally require a bachelor's degree or higher in a specific technical or scientific field, which supports EB-2 or EB-3 immigrant visa petitions through the PERM labor certification process. Roles requiring advanced or specialized expertise may also qualify for EB-2 National Interest Waiver consideration.
How do I find medical devices Green Card sponsorship jobs in North Carolina?
Migrate Mate filters job listings specifically by visa sponsorship type, so you can search for medical devices roles in North Carolina where employers are actively offering Green Card sponsorship. This saves time compared to sorting through general job boards where sponsorship details are rarely stated upfront. Migrate Mate's listings are tagged by industry and visa category, making it straightforward to identify relevant opportunities across the Research Triangle, Charlotte, and Triad markets.
Are there any state-specific or industry-specific considerations for Green Card sponsorship in North Carolina's medical devices sector?
North Carolina does not impose state-level immigration requirements on top of federal PERM and USCIS processes, but the medical devices industry adds regulatory complexity that affects sponsorship timelines. FDA-regulated roles often require demonstrated compliance or clinical expertise, and employers typically need time to document that no qualified U.S. worker is available before filing PERM. North Carolina's competitive medtech talent pool around Research Triangle Park means employers in that area are generally more experienced with the sponsorship process than those in smaller markets.
What is the prevailing wage for Green Card medical devices jobs in North Carolina?
U.S. employers sponsoring a visa must pay at least the prevailing wage, which is what workers in the same role, area, and experience level typically earn. The Department of Labor sets this rate to make sure companies aren't hiring foreign workers simply because they'd accept lower pay than a U.S. worker. It varies by job title, location, and experience. You can look up current prevailing wage rates for any occupation and location using the OFLC Wage Search page.