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Lab Instruments Software Validation Analyst / Technical Writers

Lab Instruments Software Validation Analyst / Technical Writers

NTT DATAHighland Heights, KY, United States
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Req ID : 342369

NTT DATA strives to hire exceptional, innovative and passionate individuals who want to grow with us. If you want to be part of an inclusive, adaptable, and forward-thinking organization, apply now.

We are currently seeking a Lab Instruments Software Validation Analyst / Technical Writers to join our team in Highland Heights, Kentucky (US-KY), United States (US).

We are currently seeking a Lab Instruments Software Validation Analyst / Technical Writer to join our team in Highland Heights, KY .

We are seeking a Lab Instruments Software Validation Analyst with 6-9 years of progressive experience in the clinical research, pharmaceutical, or biotechnology industry. The successful candidate will be responsible for ensuring the reliability, accuracy, and regulatory compliance of laboratory instruments and software systems used in clinical trials.

This role requires a strong technical background in validation methodologies, regulatory compliance, and equipment qualification, along with the ability to collaborate effectively with cross-functional teams. The candidate should bring at least 3-5 years of focused, hands-on expertise in specialized validation skill areas.

Validation Planning & Execution

  • Develop, review, and execute validation protocols (DQ, IQ, OQ, PQ) for laboratory instruments and computerized systems.
  • Support integration, regression, and performance testing of software and equipment.
  • Participate in validation execution in GxP-regulated facilities .

Documentation & Compliance

  • Prepare and maintain validation life cycle documentation including URS, FRS, Risk Assessments, Traceability Matrix, SOPs, and Validation Summary Reports.
  • Ensure compliance with FDA 21 CFR Part 11, EU Annex 11, cGMP, and GAMP 5 guidelines.
  • Contribute to periodic reviews and revalidation processes for laboratory systems.
  • Risk Management & CAPA

  • Conduct risk assessments and gap analyses to identify potential issues.
  • Assist in deviation investigations and support Corrective and Preventive Actions (CAPA) implementation.
  • Collaboration & Continuous Improvement

  • Work closely with Quality Assurance, R&D, Production, and IT teams to deliver validation deliverables.
  • Collaborate with hardware / software development teams on troubleshooting and debugging activities.
  • Recommend process improvements and contribute to updates of SOPs and validation practices.
  • Qualifications

  • 6+ years of experience in laboratory instruments and software validation within a clinical, research, pharmaceutical, or biotechnology environment.
  • 3+ years of specialized experience in the following areas :
  • Validation of analytical instrument systems (e.g., spectroscopy, chromatography, protein analyzers, PCR systems, sequencers).

  • Equipment qualification (DQ, IQ, OQ, PQ).
  • Regulatory compliance with FDA 21 CFR Part 11, EU Annex 11, cGMP, GAMP 5.
  • Validation documentation authoring (Validation Plans, URS / FRS, Risk Assessments, Traceability Matrix, Validation Reports).
  • Risk management and CAPA support for validated systems.
  • #LI-NorthAmerica

    About NTT DATA

    NTT DATA is a $30 billion trusted global innovator of business and technology services. We serve 75% of the Fortune Global 100 and are committed to helping clients innovate, optimize and transform for long term success. As a Global Top Employer, we have diverse experts in more than 50 countries and a robust partner ecosystem of established and start-up companies. Our services include business and technology consulting, data and artificial intelligence, industry solutions, as well as the development, implementation and management of applications, infrastructure and connectivity. We are one of the leading providers of digital and AI infrastructure in the world. NTT DATA is a part of NTT Group, which invests over $3.6 billion each year in R&D to help organizations and society move confidently and sustainably into the digital future. Visit us at us.nttdata.com

    Whenever possible, we hire locally to NTT DATA offices or client sites. This ensures we can provide timely and effective support tailored to each client's needs. While many positions offer remote or hybrid work options, these arrangements are subject to change based on client requirements. For employees near an NTT DATA office or client site, in-office attendance may be required for meetings or events, depending on business needs. At NTT DATA, we are committed to staying flexible and meeting the evolving needs of both our clients and employees. NTT DATA recruiters will never ask for payment or banking information and will only use @nttdata.com and @talent.nttdataservices.com email addresses. If you are requested to provide payment or disclose banking information, please submit a contact us form,

    NTT DATA endeavors to make accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact us at This contact information is for accommodation requests only and cannot be used to inquire about the status of applications. NTT DATA is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. For our EEO Policy Statement, please click here. If you'd like more information on your EEO rights under the law, please click here. For Pay Transparency information, please click here.

    #LI-NorthAmerica

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    Technical Analyst • Highland Heights, KY, United States

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