TN Visa Validation Specialist Jobs
Validation Specialist roles qualify for TN visa sponsorship under the USMCA treaty for Canadian and Mexican professionals with degrees in engineering, chemistry, or a related technical field. No lottery, no annual cap for Canadians, and your employer files directly at the port of entry or via USCIS.
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Get Access To All JobsDate: Sep 9, 2026
Location: Somerset, NJ, US
Company: Lupin
Job Description
- Ensure compliance with regulatory requirements including 21 CFR Part 11, Electronic Records and Electronic Signatures, and applicable predicate rules, aligned with CSA (Computer Software Assurance) and GAMP 5 principles.
- Support validation activities in GMP laboratory and manufacturing systems, including system implementation, upgrades, and remediation.
- Work on networked and standalone systems, including PLC/firmware-based computerized systems.
-
Implement and assess IT and Data Integrity controls, including:
-
User access management
-
Audit trail configuration and review
-
Data protection and integrity controls
-
Backup, restore, and disaster recovery processes
-
Author and review validation lifecycle documentation, including:
-
User Requirements Specification (URS)
-
Functional Requirements Specification (FRS)
-
System Configuration/Design Specifications
-
Prepare, execute, and document validation protocols, including:
-
IQ, OQ, PQ, and UAT
-
Requirements Traceability Matrix (RTM)
-
Discrepancy reports and validation summary reports
-
Collaborate with business stakeholders to gather requirements and ensure timely reviews and approvals of validation documentation.
- Support and manage activities within quality systems such as TrackWise Digital, Veeva, and prior experience in using electronic systems is mandatory.
- Execute system upgrades (including SaaS systems), PLC/SCADA/Firmware-based systems and perform validation activities to maintain systems in a validated state.
- Act as a System Administrator for GxP systems, including configuration and troubleshooting whenever required.
- Coordinate with cross-functional teams (QA, IT, Engineering, QC, Production) and external vendors to ensure successful project execution.
- Deliver multiple projects independently within defined timelines, ensuring compliance with internal SOPs and GMP standards.
- Conduct CSV remediations, gap assessments, risk assessments, and periodic reviews.
Qualification and Experience
- MS/BA Degree in Computer Science, IT, Engineering, Science, or Business
- Bachelor’s degree in engineering, Computer Science, or a related technical discipline.
- Strong knowledge of CSV lifecycle, GAMP 5, and 21 CFR Part 11 compliance requirements.
- Demonstrated experience in GMP-regulated environments (pharmaceutical or biotech).
- Hands-on experience with validation documentation and protocol execution (IQ/OQ/PQ/UAT).
- Strong understanding of data integrity principles and IT controls in GxP systems.
- Experience with enterprise and laboratory systems, including networked and standalone systems.
- Familiarity with QMS/DMS platforms such as TrackWise Digital, Veeva Vault, or MasterControl.
- Experience supporting system upgrades and SaaS validation activities.
- Strong communication and stakeholder engagement skills.
- Prior experience as a System Administrator in GxP-regulated systems is preferred.
The physical requirements of the position generally include: standing, walking, sitting, using hands and fingers, reaching with hands and arms, talking and hearing. In some circumstances, bending, kneeling, crouching, stooping, and crawling may apply. This position may require lifting up to 35 pounds occasionally. Generally work is performed in a combination of a corporate and manufacturing environment.
Lupin is an equal opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, national origin, gender, religion, age, disability, veteran’s status, or any other classification as required by applicable law.
This is an exciting opportunity for a quality-driven leader passionate about advancing patient-centric drug-device combination products and ensuring the highest standards of compliance and operational excellence.
Compensation
- The anticipated salary range for this position in New Jersey is $90,000 - $110,000.00, plus discretionary performance bonus (based upon eligibility). The final salary offered to a successful candidate may vary, and will be dependent on several factors that may include but are not limited to: the type and length of experience within the job, type and length of experience within the industry, skillset, education, business needs, etc. Lupin is a multi-state employer, and this salary range may not reflect positions that work in other states.
Physical Requirements
The physical requirements of the position generally include: standing, walking, sitting, using hands and fingers, reaching with hands and arms, talking and hearing. In some circumstances, bending, kneeling, crouching, stooping, and crawling may apply. This position may require lifting up to 15 pounds occasionally. Generally work is performed in an office environment.
Competencies
- Collaboration
- Customer Centricity
- Developing Talent
- Innovation & Creativity
- Process Excellence
- Result Orientation
- Stakeholder Management
- Strategic Agility
Nearest Major Market: New Jersey
Date: Sep 9, 2026
Location: Somerset, NJ, US
Company: Lupin
Job Description
- Ensure compliance with regulatory requirements including 21 CFR Part 11, Electronic Records and Electronic Signatures, and applicable predicate rules, aligned with CSA (Computer Software Assurance) and GAMP 5 principles.
- Support validation activities in GMP laboratory and manufacturing systems, including system implementation, upgrades, and remediation.
- Work on networked and standalone systems, including PLC/firmware-based computerized systems.
-
Implement and assess IT and Data Integrity controls, including:
-
User access management
-
Audit trail configuration and review
-
Data protection and integrity controls
-
Backup, restore, and disaster recovery processes
-
Author and review validation lifecycle documentation, including:
-
User Requirements Specification (URS)
-
Functional Requirements Specification (FRS)
-
System Configuration/Design Specifications
-
Prepare, execute, and document validation protocols, including:
-
IQ, OQ, PQ, and UAT
-
Requirements Traceability Matrix (RTM)
-
Discrepancy reports and validation summary reports
-
Collaborate with business stakeholders to gather requirements and ensure timely reviews and approvals of validation documentation.
- Support and manage activities within quality systems such as TrackWise Digital, Veeva, and prior experience in using electronic systems is mandatory.
- Execute system upgrades (including SaaS systems), PLC/SCADA/Firmware-based systems and perform validation activities to maintain systems in a validated state.
- Act as a System Administrator for GxP systems, including configuration and troubleshooting whenever required.
- Coordinate with cross-functional teams (QA, IT, Engineering, QC, Production) and external vendors to ensure successful project execution.
- Deliver multiple projects independently within defined timelines, ensuring compliance with internal SOPs and GMP standards.
- Conduct CSV remediations, gap assessments, risk assessments, and periodic reviews.
Qualification and Experience
- MS/BA Degree in Computer Science, IT, Engineering, Science, or Business
- Bachelor’s degree in engineering, Computer Science, or a related technical discipline.
- Strong knowledge of CSV lifecycle, GAMP 5, and 21 CFR Part 11 compliance requirements.
- Demonstrated experience in GMP-regulated environments (pharmaceutical or biotech).
- Hands-on experience with validation documentation and protocol execution (IQ/OQ/PQ/UAT).
- Strong understanding of data integrity principles and IT controls in GxP systems.
- Experience with enterprise and laboratory systems, including networked and standalone systems.
- Familiarity with QMS/DMS platforms such as TrackWise Digital, Veeva Vault, or MasterControl.
- Experience supporting system upgrades and SaaS validation activities.
- Strong communication and stakeholder engagement skills.
- Prior experience as a System Administrator in GxP-regulated systems is preferred.
The physical requirements of the position generally include: standing, walking, sitting, using hands and fingers, reaching with hands and arms, talking and hearing. In some circumstances, bending, kneeling, crouching, stooping, and crawling may apply. This position may require lifting up to 35 pounds occasionally. Generally work is performed in a combination of a corporate and manufacturing environment.
Lupin is an equal opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, national origin, gender, religion, age, disability, veteran’s status, or any other classification as required by applicable law.
This is an exciting opportunity for a quality-driven leader passionate about advancing patient-centric drug-device combination products and ensuring the highest standards of compliance and operational excellence.
Compensation
- The anticipated salary range for this position in New Jersey is $90,000 - $110,000.00, plus discretionary performance bonus (based upon eligibility). The final salary offered to a successful candidate may vary, and will be dependent on several factors that may include but are not limited to: the type and length of experience within the job, type and length of experience within the industry, skillset, education, business needs, etc. Lupin is a multi-state employer, and this salary range may not reflect positions that work in other states.
Physical Requirements
The physical requirements of the position generally include: standing, walking, sitting, using hands and fingers, reaching with hands and arms, talking and hearing. In some circumstances, bending, kneeling, crouching, stooping, and crawling may apply. This position may require lifting up to 15 pounds occasionally. Generally work is performed in an office environment.
Competencies
- Collaboration
- Customer Centricity
- Developing Talent
- Innovation & Creativity
- Process Excellence
- Result Orientation
- Stakeholder Management
- Strategic Agility
Nearest Major Market: New Jersey
See all 318+ TN Visa Validation Specialist Jobs
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Get Access To All JobsTips for Finding TN Visa Sponsorship as a Validation Specialist
Align your credential to the TN category
Validation Specialist roles most often qualify under the Engineer or Chemist TN visa category. Pull your transcripts now and confirm your degree field maps to the category your target job description requires before applying.
Target regulated industries with validation mandates
Pharmaceutical, medical device, and biotech employers routinely hire Validation Specialists because FDA 21 CFR Part 11 and GMP regulations require it. These companies already understand TN sponsorship and file it as a standard part of onboarding.
Request a support letter before your border crossing
Canadians applying at a port of entry need a detailed employer support letter stating the TN category, job duties, and your qualifications. A vague letter is the most common reason CBP officers ask for additional review on the spot.
Use Migrate Mate to find employers actively sponsoring TN roles
Search Migrate Mate to identify Validation Specialist openings at employers with recent visa filings. Filtering by role and industry cuts the time you spend pursuing employers experienced with work visa sponsorship.
Clarify GMP validation scope during offer negotiations
TN petitions require a precise job description. Ask the hiring manager for a written scope of duties covering equipment, process, or software validation before accepting an offer, so your support letter matches your actual work.
Understand Mexican TN allocation and plan your timeline accordingly
Mexico has a 5,500 annual TN cap, processed by USCIS rather than at the border. File early in the fiscal year and budget for USCIS premium processing to avoid delays that could push your start date.
Validation Specialist TN Visa: Frequently Asked Questions
Does a Validation Specialist role qualify for TN visa status?
Yes, Validation Specialist positions typically qualify under the Engineer or Chemist TN category, depending on your degree and the job duties. Your degree field must align with the TN category listed in the petition. Roles focused on software validation or process validation in regulated industries like pharma and medical devices are the most straightforward cases.
How does TN compare to H-1B for Validation Specialist roles?
TN has no lottery and no annual cap for Canadians, so you can start as soon as your employer files and you clear entry. H-1B visa requires surviving a random lottery, waiting until October 1 to begin work, and competing with hundreds of thousands of other applicants. For Validation Specialists with Canadian citizenship, TN is the faster and more predictable path.
What documents do I need to support a TN petition as a Validation Specialist?
You need a detailed employer support letter naming the TN category, describing your validation duties, and confirming your qualifications. You also need your degree transcripts and, if your degree is from outside the U.S. or Canada, a credential evaluation. Canadians bring these to the port of entry; Mexican citizens file through USCIS with Form I-129.
Where can I find Validation Specialist jobs with TN visa sponsorship?
Migrate Mate is built specifically for TN-eligible professionals and lists Validation Specialist roles at employers experienced with TN sponsorship. Searching by role and industry there saves you from pursuing companies that have never filed a TN petition and would need to start from scratch.
Can my TN status as a Validation Specialist be renewed indefinitely?
TN status is granted in three-year increments with no statutory limit on renewals, as long as you maintain a qualifying job offer and continue to meet the category requirements. Canadians renew at a port of entry or through USCIS; Mexican citizens renew through USCIS. Each renewal requires a current employer support letter reflecting your active role.