Validation Specialist Jobs in USA with Visa Sponsorship
Validation Specialist roles attract strong H-1B visa sponsorship because the work requires a specific technical degree, meets specialty occupation standards, and employers in pharma, biotech, and medical devices regularly hire internationally. Most roles are full-time, permanent positions with multi-year visa pathways. For detailed occupation requirements, see the O*NET profile.
Find Validation Specialist JobsOverview
Showing 5 of 45+ Validation Specialist jobs
See all 45+ Validation Specialist Jobs
Sign up for free to unlock all listings, filter by visa type, and get alerts for new Validation Specialist roles.
Get Access To All JobsINTRODUCTION
Piramal Pharma Solutions is a contract development and manufacturing organization (CDMO), offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our clients through a globally integrated network of facilities in North America, Europe and Asia.
This enables us to offer a comprehensive range of services including Drug Discovery Solutions, Process & Pharmaceutical Development services, Clinical Trial Supplies, Commercial supply of APIs and Finished dosage forms. We also offer specialized services like development and manufacture of Highly Potent APIs and Antibody Drug Conjugation.
Our capability as an integrated service provider & experience with various technologies enables us to serve Innovator and Generic companies worldwide.
ROLE AND RESPONSIBILITIES:
Reporting to the Validation Supervisor, the Validation Specialist executes validation and qualification protocols of manufacturing, packaging, laboratory, utility systems and other equipment, in accordance with current Good Manufacturing Practices (cGMPs), Good Engineering Practices (GEP) and change control.
This position reports to the Validation Supervisor.
Key Responsibilities:
- Write, schedule, plan, manage and execute validation and qualification protocols
- Act as technical interface between the company and 3rd parties for discussions surrounding the on-site validation activities
- Coordinate and interface with Operations, Technical Services, Facility Engineering, Microbiology, and Quality Assurance groups to ensure successful project execution
- Lead qualification activities and timelines for equipment purchased for manufacturing purposes
- Coordinate order timelines and equipment requirements with Technical Services group
- Represent validation at project team meetings and provide expert validation advice
- Independently design, plan and manage own studies
-
Manage the development of the following documents for new equipment:
-
User requirement specification (URS)
-
Design qualification (DQ)
-
Commissioning (CX)
-
Risk assessment (RA)
-
Maintain and develop state of the art knowledge regarding existing and future validation processes and maintain up-to-date knowledge on regulatory expectations
- Lead investigations related to validation discrepancies and ensure thoroughness of investigation, documentation and closure
- Implement preventive/corrective actions as necessary
- Conduct periodic validation reviews of equipment, facilities, utilities, and sterilization cycles
- Author assigned Standard Operating Procedures (SOPs) for Validation department
BASIC QUALIFICATIONS:
- Bachelor’s Degree in the physical or biological sciences or engineering preferred
- 2+ years of QA and/or Regulatory experience in a cGMP/FDA regulated environment
- Sterile manufacturing of injectables strongly preferred
- Thorough knowledge of cGMP (Current Good Manufacturing Practice) regulations, guidance, and general compliance expectations
- Technical writing skills
- In-depth understanding of investigational techniques, including but not limited to root cause analysis, risk assessment, impact evaluation, and technical report writing
- Working knowledge of cGMP data management systems (EDMS, Trackwise, and/or SAP)
- Thorough understanding of Common Technical Document (primarily Chemistry and Manufacturing Controls (CMC) format, content, and filing requirements for US and EU)
- High level of proficiency operating all Microsoft Office applications
- Excellent communication skills, both verbally and in writing
- Detail oriented and organized
LOCATION
Location: Lexington
INTRODUCTION
Piramal Pharma Solutions is a contract development and manufacturing organization (CDMO), offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our clients through a globally integrated network of facilities in North America, Europe and Asia.
This enables us to offer a comprehensive range of services including Drug Discovery Solutions, Process & Pharmaceutical Development services, Clinical Trial Supplies, Commercial supply of APIs and Finished dosage forms. We also offer specialized services like development and manufacture of Highly Potent APIs and Antibody Drug Conjugation.
Our capability as an integrated service provider & experience with various technologies enables us to serve Innovator and Generic companies worldwide.
ROLE AND RESPONSIBILITIES:
Reporting to the Validation Supervisor, the Validation Specialist executes validation and qualification protocols of manufacturing, packaging, laboratory, utility systems and other equipment, in accordance with current Good Manufacturing Practices (cGMPs), Good Engineering Practices (GEP) and change control.
This position reports to the Validation Supervisor.
Key Responsibilities:
- Write, schedule, plan, manage and execute validation and qualification protocols
- Act as technical interface between the company and 3rd parties for discussions surrounding the on-site validation activities
- Coordinate and interface with Operations, Technical Services, Facility Engineering, Microbiology, and Quality Assurance groups to ensure successful project execution
- Lead qualification activities and timelines for equipment purchased for manufacturing purposes
- Coordinate order timelines and equipment requirements with Technical Services group
- Represent validation at project team meetings and provide expert validation advice
- Independently design, plan and manage own studies
-
Manage the development of the following documents for new equipment:
-
User requirement specification (URS)
-
Design qualification (DQ)
-
Commissioning (CX)
-
Risk assessment (RA)
-
Maintain and develop state of the art knowledge regarding existing and future validation processes and maintain up-to-date knowledge on regulatory expectations
- Lead investigations related to validation discrepancies and ensure thoroughness of investigation, documentation and closure
- Implement preventive/corrective actions as necessary
- Conduct periodic validation reviews of equipment, facilities, utilities, and sterilization cycles
- Author assigned Standard Operating Procedures (SOPs) for Validation department
BASIC QUALIFICATIONS:
- Bachelor’s Degree in the physical or biological sciences or engineering preferred
- 2+ years of QA and/or Regulatory experience in a cGMP/FDA regulated environment
- Sterile manufacturing of injectables strongly preferred
- Thorough knowledge of cGMP (Current Good Manufacturing Practice) regulations, guidance, and general compliance expectations
- Technical writing skills
- In-depth understanding of investigational techniques, including but not limited to root cause analysis, risk assessment, impact evaluation, and technical report writing
- Working knowledge of cGMP data management systems (EDMS, Trackwise, and/or SAP)
- Thorough understanding of Common Technical Document (primarily Chemistry and Manufacturing Controls (CMC) format, content, and filing requirements for US and EU)
- High level of proficiency operating all Microsoft Office applications
- Excellent communication skills, both verbally and in writing
- Detail oriented and organized
LOCATION
Location: Lexington
See all 45+ Validation Specialist Jobs
Sign up for free to unlock all listings, filter by visa type, and get alerts for new Validation Specialist roles.
Get Access To All JobsTips for Finding Visa Sponsorship as a Validation Specialist
Confirm your degree field matches the role
Validation Specialist positions typically require a degree in engineering, life sciences, chemistry, or a related field. A general science degree may qualify, but a mismatch between your major and the job's technical requirements can trigger an H-1B RFE.
Target regulated industries with established sponsorship pipelines
Pharmaceutical, biotechnology, and medical device companies sponsor Validation Specialists most consistently. These industries operate under FDA oversight, meaning validation is a core compliance function, not an optional hire, which makes sponsorship far more defensible.
Understand the specialty occupation argument for your specific role
USCIS scrutinizes validation roles that list a degree as preferred rather than required. Before accepting an offer, confirm the job description explicitly requires a bachelor's degree in a specific technical field to avoid petition complications.
Ask employers about their H-1B cap-exempt status
Universities, research hospitals, and nonprofits affiliated with higher education institutions are cap-exempt. Joining one means you skip the H-1B lottery entirely and can file any time of year, which significantly improves your odds of securing status.
Document your GMP and regulatory experience clearly
Employers sponsoring Validation Specialists need to demonstrate the role requires specialized knowledge. Your resume should explicitly reference GMP, FDA 21 CFR Part 11, IQ/OQ/PQ protocols, or equivalent frameworks to support the specialty occupation petition.
Use Migrate Mate to find employers who have sponsored before
Not every company that posts validation roles will sponsor visas. Migrate Mate filters jobs by sponsorship willingness, so you spend time applying to employers who have already committed to hiring internationally rather than guessing from a generic job listing.
Frequently Asked Questions
Do Validation Specialist roles qualify for H-1B sponsorship?
Yes, most do, but the petition needs to establish specialty occupation status. Roles in pharmaceutical, biotech, or medical device companies that require a degree in engineering, chemistry, or life sciences have a strong track record of H-1B visa approval. Roles where any bachelor's degree satisfies the requirement are harder to sponsor and face higher RFE rates from USCIS.
What degree do I need for a sponsored Validation Specialist position?
Most employers require a bachelor's degree in chemical engineering, biomedical engineering, pharmaceutical sciences, chemistry, or a closely related field. Some roles accept biology or microbiology for validation work tied to laboratory systems. A general business or unrelated technical degree will not support an H-1B petition for this role, even if you have years of relevant experience.
How do I find Validation Specialist jobs that offer visa sponsorship?
Migrate Mate lists Validation Specialist roles specifically filtered for employers willing to sponsor work visas. This is more reliable than browsing general job boards, where sponsorship willingness is either unstated or buried in the job description. Searching by role on Migrate Mate surfaces employers with a demonstrated history of international hires in this function.
Can Validation Specialist experience substitute for a degree on an H-1B petition?
Only in limited circumstances. USCIS allows three years of specialized experience to substitute for one year of university education, but this is difficult to apply in practice for roles that industry norm treats as degree-required. If your employer's own job postings for the same title consistently require a degree, experience substitution arguments are unlikely to succeed without an immigration attorney building a detailed evidentiary record.
Are there visa options beyond H-1B for Validation Specialists?
Yes. Australian citizens can apply for the E-3 visa, which has no lottery and a separate annual allocation. Canadian and Mexican nationals may qualify under TN visa status if the role maps to a covered USMCA category. O-1A is an option for senior validation professionals who have published, led industry groups, or received formal recognition in their field, though the bar is significantly higher.
What is the prevailing wage requirement for sponsored Validation Specialist jobs?
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.