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Lab Instruments Software Validation Analyst
Highland Heights, United States
Job Description:
NTT DATA's Client is seeking an experienced Lab Instruments Software Validation Analyst with 10+ years of proven expertise in the clinical research industry, including a minimum of 5+ years of hands-on, specialized experience in analytical instrument/software validation and equipment qualification to join their team in Highland Heights, KY. This role ensures the reliability, accuracy, and regulatory compliance of laboratory instrument software and computerized systems used in clinical trials.
The ideal candidate will have in-depth knowledge of Good Clinical Practice (GCP), Good Laboratory Practice (GLP), cGMP, and regulatory guidelines such as FDA 21 CFR Part 11 and EU Annex 11, along with strong leadership and cross-functional collaboration skills.
Key Responsibilities:
Validation Planning & Execution
Lead and execute validation protocols (DQ, IQ, OQ, PQ) for analytical instruments and laboratory software.
Design and implement integration, regression, and performance testing strategies.
Oversee validation execution in GxP facilities, ensuring compliance with SOPs and international standards.
Documentation & Compliance
Author, review, and maintain validation life cycle documentation, including URS, FRS, Traceability Matrix, Risk Assessments, Validation Summary Reports, SOPs, and technical specifications.
Ensure validation deliverables comply with FDA 21 CFR Part 11, EU Annex 11, GAMP 5, and internal policies.
Conduct periodic system reviews and manage revalidation activities.
Risk Management & CAPA
Perform in-depth risk assessments and gap analyses to mitigate compliance risks.
Lead investigations into deviations and ensure effective Corrective and Preventive Actions (CAPA) are implemented.
Collaboration & Leadership
Collaborate with Quality Assurance, R&D, Production, IT, and global teams to deliver validation outcomes.
Partner with software/hardware development teams for issue resolution and debugging.
Mentor and train junior analysts, fostering knowledge sharing and best practices.
Required Skills & Experience:
10+ years of progressive experience in laboratory instrument and software validation within the clinical research, pharmaceutical, or biotechnology industry.
5+ years of hands-on expertise in the following skill areas:
Analytical instrument systems validation (e.g., spectroscopy, chromatography, protein analyzers, next-gen sequencers, PCR systems).
Equipment qualification (DQ, IQ, OQ, PQ) and computerized system validation.
Regulatory compliance with FDA 21 CFR Part 11, EU Annex 11, cGMP, GAMP 5.
Risk assessment, root cause analysis, and CAPA management.
Validation documentation authoring and review (Validation Plans, URS/FRS, Risk Assessment Documents, Traceability Matrices, Validation Summary Reports).
Process improvement and SOP/work practice development in validation life cycle management.
Strong leadership skills with the ability to manage multiple validation projects simultaneously.
Excellent communication, technical writing, and collaboration skills across global teams.
Education:
Bachelor's or Master's degree in Life Sciences, Biotechnology, Pharmaceutical Sciences, Chemistry, Engineering, or related discipline.
Preferred certifications: Computer System Validation (CSV), GAMP 5 Practitioner, or Quality/Regulatory Compliance credentials.
About NTT DATA Services:
NTT DATA Services is a recognized leader in IT and business services, including cloud, data and applications, headquartered in Texas. As part of NTT DATA, a $30 billion trusted global innovator with a combined global reach of over 80 countries, we help clients transform through business and technology consulting, industry and digital solutions, applications development and management, managed edge-to-cloud infrastructure services, BPO, systems integration and global data centers. We are committed to our clients' long-term success. Visit nttdata.com or LinkedIn to learn more.
NTT DATA Services is an equal opportunity employer and considers all applicants without regarding to race, color, religion, citizenship, national origin, ancestry, age, sex, sexual orientation, gender identity, genetic information, physical or mental disability, veteran or marital status, or any other characteristic protected by law. We are committed to creating a diverse and inclusive environment for all employees. If you need assistance or an accommodation due to a disability, please inform your recruiter so that we may connect you with the appropriate team..
This position is eligible for company benefits that will depend on the nature of the role offered. Company benefits may include medical, dental, and vision insurance, flexible spending or health savings account, life, and AD&D insurance, short-and long-term disability coverage, paid time off, employee assistance, participation in a 401k program with company match, and additional voluntary or legally required benefits.
#LI-NorthAmerica
NTT DATA's Client is seeking an experienced Lab Instruments Software Validation Analyst with 10+ years of proven expertise in the clinical research industry, including a minimum of 5+ years of hands-on, specialized experience in analytical instrument/software validation and equipment qualification to join their team in Highland Heights, KY. This role ensures the reliability, accuracy, and regulatory compliance of laboratory instrument software and computerized systems used in clinical trials.
The ideal candidate will have in-depth knowledge of Good Clinical Practice (GCP), Good Laboratory Practice (GLP), cGMP, and regulatory guidelines such as FDA 21 CFR Part 11 and EU Annex 11, along with strong leadership and cross-functional collaboration skills.
Key Responsibilities:
Validation Planning & Execution
Lead and execute validation protocols (DQ, IQ, OQ, PQ) for analytical instruments and laboratory software.
Design and implement integration, regression, and performance testing strategies.
Oversee validation execution in GxP facilities, ensuring compliance with SOPs and international standards.
Documentation & Compliance
Author, review, and maintain validation life cycle documentation, including URS, FRS, Traceability Matrix, Risk Assessments, Validation Summary Reports, SOPs, and technical specifications.
Ensure validation deliverables comply with FDA 21 CFR Part 11, EU Annex 11, GAMP 5, and internal policies.
Conduct periodic system reviews and manage revalidation activities.
Risk Management & CAPA
Perform in-depth risk assessments and gap analyses to mitigate compliance risks.
Lead investigations into deviations and ensure effective Corrective and Preventive Actions (CAPA) are implemented.
Collaboration & Leadership
Collaborate with Quality Assurance, R&D, Production, IT, and global teams to deliver validation outcomes.
Partner with software/hardware development teams for issue resolution and debugging.
Mentor and train junior analysts, fostering knowledge sharing and best practices.
Required Skills & Experience:
10+ years of progressive experience in laboratory instrument and software validation within the clinical research, pharmaceutical, or biotechnology industry.
5+ years of hands-on expertise in the following skill areas:
Analytical instrument systems validation (e.g., spectroscopy, chromatography, protein analyzers, next-gen sequencers, PCR systems).
Equipment qualification (DQ, IQ, OQ, PQ) and computerized system validation.
Regulatory compliance with FDA 21 CFR Part 11, EU Annex 11, cGMP, GAMP 5.
Risk assessment, root cause analysis, and CAPA management.
Validation documentation authoring and review (Validation Plans, URS/FRS, Risk Assessment Documents, Traceability Matrices, Validation Summary Reports).
Process improvement and SOP/work practice development in validation life cycle management.
Strong leadership skills with the ability to manage multiple validation projects simultaneously.
Excellent communication, technical writing, and collaboration skills across global teams.
Education:
Bachelor's or Master's degree in Life Sciences, Biotechnology, Pharmaceutical Sciences, Chemistry, Engineering, or related discipline.
Preferred certifications: Computer System Validation (CSV), GAMP 5 Practitioner, or Quality/Regulatory Compliance credentials.
About NTT DATA Services:
NTT DATA Services is a recognized leader in IT and business services, including cloud, data and applications, headquartered in Texas. As part of NTT DATA, a $30 billion trusted global innovator with a combined global reach of over 80 countries, we help clients transform through business and technology consulting, industry and digital solutions, applications development and management, managed edge-to-cloud infrastructure services, BPO, systems integration and global data centers. We are committed to our clients' long-term success. Visit nttdata.com or LinkedIn to learn more.
NTT DATA Services is an equal opportunity employer and considers all applicants without regarding to race, color, religion, citizenship, national origin, ancestry, age, sex, sexual orientation, gender identity, genetic information, physical or mental disability, veteran or marital status, or any other characteristic protected by law. We are committed to creating a diverse and inclusive environment for all employees. If you need assistance or an accommodation due to a disability, please inform your recruiter so that we may connect you with the appropriate team..
This position is eligible for company benefits that will depend on the nature of the role offered. Company benefits may include medical, dental, and vision insurance, flexible spending or health savings account, life, and AD&D insurance, short-and long-term disability coverage, paid time off, employee assistance, participation in a 401k program with company match, and additional voluntary or legally required benefits.
#LI-NorthAmerica
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