Raas Infotek · 11 hours ago
Validation (CSV) Analyst (USC/GC Only)
Secaucus, NJ
Contract
Hybrid
Entry, Mid Level
2+ years expRaas Infotek is seeking a Validation Analyst who will be responsible for planning, executing, and documenting validation activities to ensure compliance with regulatory requirements and internal quality standards. The role involves supporting Computer System Validation (CSV), equipment qualification, and process validation across the organization.
Information Technology
No H1B
Hiring Manager
Ravi kumar
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
Raas Infotek
RAAS Infotek is a full spectrum global Information Technology services company, providing end-to-end business solutions.
201-500 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase