🚨 We're Hiring: CSV Validation Engineers

📍 Location: Irvine, TX and Santa Clara, CA (Onsite Only)
🏢 Client: TCS / Johnson & Johnson
🔢 Requirement IDs: 10165846 / 47 / 48 / 49
💵 Rate: $40/hr (W2)
⏳ Duration: Long-term Contract

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🛠 Key Responsibilities

• Develop, implement, and maintain QA processes for non-product software in the medical device space
• Ensure compliance with FDA, ISO 13485, IEC 62304, GxP, and 21 CFR Part 11 standards
• Create & review validation documentation including:
  • User & Functional Requirements
  • Validation Plans, IQ/OQ/PQ Protocols
  • Summary & Exception Reports
  • Traceability Matrices
  • Periodic Reviews & System Decommissioning
• Execute dry/test runs of validation protocols
• Support audits/inspections and maintain a validated state for systems
• Collaborate with software and IT teams on best QA/compliance practices
• Drive continuous improvement aligned with quality management systems

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📌 Required Competencies

• Strong experience in CSV (Computer System Validation)
• Understanding of GxP, 21 CFR Part 11, FDA regulations
• Experience with ISO 13485 and IEC 62304 standards
• Background in medical devices or related regulated environments
• Excellent documentation and protocol creation skills
• Knowledge of EIS: Medical Device & Regulations

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📬 Submit Resumes

Please send qualified resumes to: raju@valzosoft.com
Use subject line: “CSV Validation Engineer – TCS/J&J – [Candidate Name]”

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📌 Tags:

CSV jobs in Texas, medical device validation, FDA CSV jobs, onsite CSV jobs California, Irvine engineering jobs, Santa Clara validation careers, GxP, Part 11, ISO 13485, TCS hiring, J&J contractor jobs

🚀 Interviews starting soon – Submit ASAP!