Lab Instruments Software Validation Analyst / Tech Writer

At NTT DATA, we know that with the right people on board, anything is possible. The quality, integrity, and commitment of our employees have been key factors in our company's growth and market presence. By hiring the best people and helping them grow both professionally and personally, we ensure a bright future for NTT DATA and for the people who work here.

For more than 25 years, NTT DATA Services have focused on impacting the core of your business operations with industry-leading outsourcing services and automation. With our industry-specific platforms, we deliver continuous value addition, and innovation that will improve your business outcomes. Outsourcing is not just a method of gaining a one-time cost advantage, but an effective strategy for gaining and maintaining competitive advantages when executed as part of an overall sourcing strategy.

NTT DATA's Client is seeking a Lab Instruments Software Validation Analyst with 6-9 years of progressive experience in the clinical research, pharmaceutical, or biotechnology industry to join their team in Highland Heights, KY. 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 clinical research, pharmaceutical, or biotechnology environment.

3-5 years of specialized experience in the following areas :

Education

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.

Where required by law, NTT DATA provides a reasonable range of compensation for specific roles. The starting hourly range for this remote role is ($40-45hourly ) . This range reflects the minimum and maximum target compensation for the position across all US locations. Actual compensation will depend on several factors, including the candidate's actual work location, relevant experience, technical skills, and other qualifications.

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.