Medical Devices TN Sponsorship Jobs in North Carolina
North Carolina's medical devices sector spans a broad corridor from the Research Triangle to Charlotte, with employers like Becton Dickinson, Teleflex, and Medtronic operating facilities across the state. Canadian and Mexican professionals in engineering, regulatory affairs, and quality assurance can pursue TN visa sponsorship with North Carolina-based manufacturers and device innovators actively hiring internationally.
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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
TN Medical Devices Job Roles in North Carolina
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Search Medical Devices Jobs in North CarolinaMedical Devices TN Sponsorship Jobs in North Carolina: Frequently Asked Questions
Which medical devices companies sponsor TN visas in North Carolina?
Several established medical devices employers in North Carolina have a track record of sponsoring TN visas, including Becton Dickinson in Durham, Teleflex in Research Triangle Park, and Medtronic's operations across the state. Contract manufacturers and diagnostics companies in the Triad region also hire TN-eligible professionals. Sponsorship availability varies by role and hiring cycle, so confirming directly with each employer's HR team is the most reliable approach.
Which cities in North Carolina have the most medical devices TN sponsorship jobs?
Research Triangle Park and the surrounding Raleigh-Durham-Chapel Hill metro area concentrate the largest share of medical devices employers in North Carolina, driven by proximity to major research universities and a dense cluster of life sciences companies. Charlotte has a growing devices and diagnostics presence, while Greensboro and the Piedmont Triad host several manufacturing-focused employers. Most corporate and regulatory roles are centered in the Triangle.
What types of medical devices roles typically qualify for TN sponsorship?
TN visas in the medical devices sector most commonly cover engineers (mechanical, electrical, biomedical, and manufacturing), regulatory affairs specialists, quality engineers, and scientists with relevant degree qualifications. The role must fall within a TN-eligible occupation category and the applicant must hold a qualifying bachelor's degree or higher directly related to the position. Roles in sales, operations management, or general administration are unlikely to qualify under TN criteria.
How do I find medical devices TN sponsorship jobs in North Carolina?
Migrate Mate is a job board built specifically for TN-eligible professionals, letting you filter by visa type, industry, and state to surface medical devices roles in North Carolina that include sponsorship. Because TN sponsorship willingness is not always listed in standard job postings, using a platform like Migrate Mate that curates sponsorship-confirmed listings saves significant research time and helps you focus on employers already open to TN candidates.
Are there any North Carolina-specific considerations for TN sponsorship in medical devices?
North Carolina's medical devices industry is heavily regulated due to FDA oversight, and many employers require candidates to understand U.S. quality system regulations, particularly 21 CFR Part 820. For TN applicants, the employer must document that the offered role matches a TN-eligible occupation and that your degree aligns with the position. Given the technical specificity of devices work, having clear documentation of your engineering or scientific credentials strengthens the TN application considerably.