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Testing & Computer System Validation (CSV) Specialist – Healthcare

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NTT DATA

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Location:
Mexico , Guadalajara

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Category:
IT - Software Development

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Contract Type:
Not provided

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Salary:

Not provided
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Job Description:

We are seeking an experienced Testing & Computer System Validation (CSV) Specialist with strong expertise in IQ, OQ, and PQ activities within the Healthcare / Life Sciences domain. The ideal candidate will ensure that computerized systems are validated and compliant with regulatory standards, supporting quality, safety, and data integrity across regulated environments.

Job Responsibility:

  • Plan, execute, and document Computer System Validation (CSV) activities in compliance with regulatory requirements (GxP, FDA, EMA, etc.)
  • Develop and review validation deliverables including Validation Plans, Risk Assessments, IQ, OQ, PQ protocols, Traceability Matrices, and Validation Summary Reports
  • Perform Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for computerized systems
  • Execute manual and automated testing activities aligned with validation requirements
  • Ensure compliance with 21 CFR Part 11, GAMP 5, and data integrity principles (ALCOA+)
  • Collaborate with cross-functional teams including Quality, IT, Business, and Vendors
  • Support audits and inspections by preparing validation evidence and responding to audit queries
  • Participate in change control, deviation management, CAPA, and periodic reviews of validated systems
  • Provide guidance and mentorship to junior validation/test team members as needed

Requirements:

  • 5–8 years of hands-on experience in Testing and Computer System Validation within the Healthcare / Life Sciences domain
  • 5+ years of strong practical experience with IQ, OQ, and PQ execution
  • 5+ years of in-depth knowledge of CSV methodologies and regulatory standards (FDA, GxP, GAMP 5)
  • 5+ years of experience validating systems such as LIMS, QMS, ERP, EMR, or Clinical systems is a plus
  • Solid understanding of SDLC, STLC, and risk-based validation approaches
  • Excellent documentation, analytical, and communication skills
  • Ability to work independently and manage multiple validation activities simultaneously

Nice to have:

  • Bachelor’s degree in Engineering, Computer Science, Life Sciences, or a related field
  • Exposure to automation testing tools or test management tools is an added advantage
  • Prior experience working in regulated environments with global clients

Additional Information:

Job Posted:
March 13, 2026

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