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Instrument Software Validation Analyst

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NTT DATA

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Location:
United States , Cincinnati

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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 Instrument Software Validation Analyst to ensure that laboratory, manufacturing, and embedded software systems operate reliably, compliantly, and in accordance with regulatory requirements (GxP/FDA/EMA). The role focuses on maintaining validated systems through structured validation processes (IQ/OQ/PQ) and serves as a bridge between technical software testing and regulatory compliance.

Job Responsibility:

  • Validate software installed on laboratory and manufacturing instruments in compliance with EMA, FDA, and GxP guidelines
  • Develop and execute validation protocols including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ)
  • Ensure systems remain in a validated state throughout their lifecycle
  • Author and maintain validation documentation including Validation Plans and Reports, User Requirement Specifications (URS), Functional/Design Specifications, Traceability Matrices
  • Ensure compliance with 21 CFR Part 11, GAMP 5, and data integrity standards
  • Gather and document system requirements
  • Develop software specifications and validation test cases
  • Create infrastructure diagrams and data flow documentation
  • Document current-state software configurations
  • Perform functional, integration, regression, and data integrity testing
  • Identify, document, and troubleshoot validation deviations
  • Conduct root cause analysis and collaborate with cross-functional teams to resolve issues
  • Conduct risk assessments (e.g., FMEA) to identify and mitigate system risks
  • Support and implement change control procedures for software updates and enhancements
  • Transition legacy SOPs to updated IT software management SOPs

Requirements:

  • Bachelor’s degree in Computer Science, Engineering, Life Sciences, or related field
  • 2–5+ years of experience in Computer System Validation (CSV) or software validation in regulated industries (pharmaceutical, biotech, or medical devices)
  • 5+ years of strong understanding of FDA, EMA, and GMP regulations, 21 CFR Part 11, GAMP 5 guidelines, Data integrity principles
  • 3 to 5 years of experience with Laboratory systems such as LIMS, Chromatography Data Systems (e.g., Empower)
  • Familiarity with validation lifecycle and documentation standards
  • Strong analytical and problem-solving skills
  • Excellent technical writing and documentation abilities
  • Attention to detail with a quality-focused mindset
  • Ability to work cross-functionally with IT, QA, and business teams

Nice to have:

  • Experience in global regulatory environments
  • Exposure to instrument software in laboratory or manufacturing settings
  • Knowledge of SOP migration and system lifecycle management

Additional Information:

Job Posted:
May 06, 2026

Work Type:
On-site work
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