Lab Instruments Software Validation Analyst

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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.

Key Responsibilities:

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.

Required Skills & Experience:

• 6–9 years of experience in laboratory instruments and software validation within a clinical research, pharmaceutical, or biotechnology environment.
• 3–5 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.
• Strong technical writing, analytical, and communication skills.
• Ability to work in global, cross-functional team environments and deliver on multiple projects concurrently.
• 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.

Education:

• Bachelor’s degree in Life Sciences, Biotechnology, Pharmaceutical Sciences, Chemistry, Engineering, or related discipline required.
• Master’s degree or professional certifications in Computer System Validation (CSV), GAMP 5, or Regulatory Compliance preferred.

Workplace Type:

Hybrid Working

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. We invest over $3.6 billion each year in R&D to help organizations and society move confidently and sustainably into the digital future. 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 also one of the leading providers of digital and AI infrastructure in the world. NTT DATA is part of NTT Group and headquartered in Tokyo.

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