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Contract role: Validation Analyst at Secaucus, NJ or Chantilly, VA (Onsite – Hybrid Model) jobs in United States
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Yochana · 1 day ago

Contract role: Validation Analyst at Secaucus, NJ or Chantilly, VA (Onsite – Hybrid Model)

Yochana is seeking a Validation Analyst to ensure compliance with regulatory requirements and internal quality standards. The role involves planning, executing, and documenting validation activities, including Computer System Validation and equipment qualification.
Business Information SystemsInformation and Communications Technology (ICT)Information ServicesInformation TechnologySoftwareStaffing Agency
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H1B Sponsor Likelynote
Hiring Manager
Naveen Babu Moggala
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Responsibilities

Develop and maintain validation documentation including Validation Plans, Risk Assessments, IQ/OQ/PQ protocols, and Summary Reports
Perform Computer System Validation (CSV) activities in alignment with GAMP 5 and 21 CFR Part 11 guidelines
Ensure compliance with GxP, ICH Q9/Q10, and other applicable regulatory standards
Execute validation testing, record results, and manage deviations/CAPA as required
Collaborate with cross-functional teams (IT, QA, Manufacturing, R&D) for validation deliverables
Support audit readiness and respond to regulatory inspections
Maintain validation traceability matrices and ensure proper documentation control
Participate in periodic reviews and re-validation activities for systems and equipment

Qualification

Computer System ValidationGAMP 5FDA 21 CFR Part 11Validation DocumentationRisk-based ValidationMS Office SuiteAnalytical SkillsERP/LIMS ValidationAutomation ToolsISPE GAMP CertificationASQ CQE CertificationCSV Specialist CertificationProblem-solving SkillsCommunication Skills

Required

Bachelor's degree in Life Sciences, Engineering, Computer Science, or related field
2–5 years of experience in Validation, Quality Assurance, or Compliance within regulated industries
Strong knowledge of CSV principles, GAMP 5, FDA 21 CFR Part 11, EU Annex 11, and HIPAA
Familiarity with risk-based validation approaches and data integrity principles
Proficiency in documentation tools and MS Office Suite
Excellent analytical, problem-solving, and communication skills

Preferred

Experience with ERP/LIMS/Clinical Systems validation
Knowledge of automation tools and AI-enabled compliance workflows
Certifications such as ISPE GAMP, ASQ CQE, or CSV Specialist are a plus

Company

Yochana

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Yochana: Your Trusted Workforce Partner Across North America & Beyond For over 16 years, Yochana has been a leading talent acquisition firm, connecting businesses with top professionals across industries.

H1B Sponsorship

Yochana has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (21)
2024 (11)
2023 (3)

Funding

Current Stage
Growth Stage

Leadership Team

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Anusha Sharath
Global Talent Acquisition Lead / HR-BP
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Company data provided by crunchbase