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.
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
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
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
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Trends of Total Sponsorships
2025 (21)
2024 (11)
2023 (3)
Funding
Current Stage
Growth StageRecent News
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