Responsibilities : • Validate software installed on laboratory and manufacturing instruments in compliance with EMA, FDA, and GxP guidelines • Develop and execute validation protocols including ...
Responsibilities : • Validate software installed on laboratory and manufacturing instruments in compliance with EMA, FDA, and GxP guidelines • Develop and execute validation protocols including ...
Laboratory Systems and Validation Manager
Cincinnati, OH · On-site
$105K - $140K/yr
Software validation of laboratory data systems to ensure data integrity and compliance with 21CFR Part 11 and EU Annex 11 requirements as well as GAMP 5 guidelines. * Responsible for system ...
Laboratory Systems and Validation Manager
Cincinnati, OH · On-site
$105K - $140K/yr
Software validation of laboratory data systems to ensure data integrity and compliance with 21CFR Part 11 and EU Annex 11 requirements as well as GAMP 5 guidelines. * Responsible for system ...
Software Development Co-Op - Fall 2026
Cincinnati, OH · On-site
$35.25 - $48.25/hr
They are seeking a Software Development Intern to assist with software development, support, and installation, as well as participate in user requirements analysis and software validation.
Software Development Co-Op - Fall 2026
Cincinnati, OH · On-site
$35.25 - $48.25/hr
They are seeking a Software Development Intern to assist with software development, support, and installation, as well as participate in user requirements analysis and software validation.
Laboratory Systems and Validation Manager
Cincinnati, OH · On-site
$105K - $140K/yr
Software validation of laboratory data systems to ensure data integrity and compliance with 21CFR Part 11 and EU Annex 11 requirements as well as GAMP 5 guidelines. * Responsible for system ...
Laboratory Systems and Validation Manager
Cincinnati, OH · On-site
$105K - $140K/yr
Software validation of laboratory data systems to ensure data integrity and compliance with 21CFR Part 11 and EU Annex 11 requirements as well as GAMP 5 guidelines. * Responsible for system ...
Laboratory Systems and Validation Manager
$105K - $140K/yr
Responsible for system administration functions for QC software systems, including data backup.Validation/verification of quality control methods to ensure active pharmaceutical ingredients are ...
Laboratory Systems and Validation Manager
$105K - $140K/yr
Responsible for system administration functions for QC software systems, including data backup.Validation/verification of quality control methods to ensure active pharmaceutical ingredients are ...
Responsibilities : • Lead validation staff in developing, coordinating, and maintaining full SDLC validation deliverables for Medpace regulated software applications, including Validation & Test ...
Responsibilities : • Lead validation staff in developing, coordinating, and maintaining full SDLC validation deliverables for Medpace regulated software applications, including Validation & Test ...
Junior Software Engineer
Cincinnati, OH · On-site
... software validation process through development, review, and/or execution of test plan/cases/scripts. • Learn patterns, approaches, and business practices across multiple development teams ...
Junior Software Engineer
Cincinnati, OH · On-site
... software validation process through development, review, and/or execution of test plan/cases/scripts. • Learn patterns, approaches, and business practices across multiple development teams ...
Lead Software Engineer
Cincinnati, OH · On-site
... software validation process through development, review, and/or execution of test plan/cases/scripts. • Provide technical and professional mentorship for junior team members. • Recommend and ...
Lead Software Engineer
Cincinnati, OH · On-site
... software validation process through development, review, and/or execution of test plan/cases/scripts. • Provide technical and professional mentorship for junior team members. • Recommend and ...
Embedded Software Engineer III
Twinsburg, OH · On-site
$90K - $130K/yr
Support software validation activities by analyzing, documenting, and resolving verification issues. * Collaborate with multidisciplinary engineering teams to ensure successful product development ...
Embedded Software Engineer III
Twinsburg, OH · On-site
$90K - $130K/yr
Support software validation activities by analyzing, documenting, and resolving verification issues. * Collaborate with multidisciplinary engineering teams to ensure successful product development ...
Senior Software Engineer (Ohio)
Akron, OH · On-site
$125 - $150/hr
Develop comprehensive test sets for validation and verification of released software. * Lead root cause analysis of issues stemming from internal and external test activities. * Lead software ...
Senior Software Engineer (Ohio)
Akron, OH · On-site
$125 - $150/hr
Develop comprehensive test sets for validation and verification of released software. * Lead root cause analysis of issues stemming from internal and external test activities. * Lead software ...
Embedded Software Engineer III
Twinsburg, OH · On-site
$90K - $130K/yr
Support software validation activities by analyzing, documenting, and resolving verification issues. * Collaborate with multidisciplinary engineering teams to ensure successful product development ...
Quick apply
Embedded Software Engineer III
Twinsburg, OH · On-site
$90K - $130K/yr
Support software validation activities by analyzing, documenting, and resolving verification issues. * Collaborate with multidisciplinary engineering teams to ensure successful product development ...
Embedded Software Engineer III
Akron, OH · On-site
$90K - $130K/yr
Support software validation activities by analyzing, documenting, and resolving verification issues. * Collaborate with multidisciplinary engineering teams to ensure successful product development ...
Quick apply
Embedded Software Engineer III
Akron, OH · On-site
$90K - $130K/yr
Support software validation activities by analyzing, documenting, and resolving verification issues. * Collaborate with multidisciplinary engineering teams to ensure successful product development ...
Embedded Software Engineer III
Cleveland, OH · On-site
$90K - $130K/yr
Support software validation activities by analyzing, documenting, and resolving verification issues. * Collaborate with multidisciplinary engineering teams to ensure successful product development ...
Quick apply
Embedded Software Engineer III
Cleveland, OH · On-site
$90K - $130K/yr
Support software validation activities by analyzing, documenting, and resolving verification issues. * Collaborate with multidisciplinary engineering teams to ensure successful product development ...
Software Engineer
Cincinnati, OH · Hybrid
Contribute to the software validation process through development, review, and/or execution of test plan/cases/scripts. * Provide technical assistance for junior team members. * Learn patterns ...
Software Engineer
Cincinnati, OH · Hybrid
Contribute to the software validation process through development, review, and/or execution of test plan/cases/scripts. * Provide technical assistance for junior team members. * Learn patterns ...
Lead validation staff in developing, coordinating, and maintaining full SDLC validation deliverables for Medpace regulated software applications, including Validation & Test Plans, User Requirements ...
Lead validation staff in developing, coordinating, and maintaining full SDLC validation deliverables for Medpace regulated software applications, including Validation & Test Plans, User Requirements ...
Embedded Software Engineer III
Twinsburg, OH · On-site
$90K - $130K/yr
Support software validation activities by analyzing, documenting, and resolving verification issues. * Collaborate with multidisciplinary engineering teams to ensure successful product development ...
Embedded Software Engineer III
Twinsburg, OH · On-site
$90K - $130K/yr
Support software validation activities by analyzing, documenting, and resolving verification issues. * Collaborate with multidisciplinary engineering teams to ensure successful product development ...
Remote MES Consultant
Columbus, OH · Remote
... software validation. Our Philosophy We believe in a simple business philosophy: Listen to our customer's needs and work closely with them to provide the highest quality solutions to help them meet ...
Remote MES Consultant
Columbus, OH · Remote
... software validation. Our Philosophy We believe in a simple business philosophy: Listen to our customer's needs and work closely with them to provide the highest quality solutions to help them meet ...
Remote MES Consultant
Columbus, OH · On-site +1
... software validation. Our Philosophy We believe in a simple business philosophy: Listen to our customer's needs and work closely with them to provide the highest quality solutions to help them meet ...
Remote MES Consultant
Columbus, OH · On-site +1
... software validation. Our Philosophy We believe in a simple business philosophy: Listen to our customer's needs and work closely with them to provide the highest quality solutions to help them meet ...
QA Software Testing Manager
Cincinnati, OH · On-site +1
Lead validation staff in developing, coordinating, and maintaining full SDLC validation deliverables for Medpace regulated software applications, including Validation & Test Plans, User Requirements ...
QA Software Testing Manager
Cincinnati, OH · On-site +1
Lead validation staff in developing, coordinating, and maintaining full SDLC validation deliverables for Medpace regulated software applications, including Validation & Test Plans, User Requirements ...
Senior Software Engineer (Ohio)
Akron, OH · On-site
$125K - $150K/yr
Develop comprehensive test sets for validation and verification of released software. * Lead root cause analysis of issues stemming from internal and external test activities. * Lead software ...
Senior Software Engineer (Ohio)
Akron, OH · On-site
$125K - $150K/yr
Develop comprehensive test sets for validation and verification of released software. * Lead root cause analysis of issues stemming from internal and external test activities. * Lead software ...
Software Validation information
What does software validation do?
In a Software Validation role, your day typically involves developing and executing test cases, identifying and documenting software defects, and collaborating closely with development and quality assurance teams. You may also participate in requirement reviews, create validation reports, and ensure that software meets specified regulatory or industry standards. Many roles involve a mix of manual and automated testing tasks to comprehensively assess software performance and functionality. Regular communication with cross-functional teams is vital to resolve issues quickly and maintain product quality. This dynamic environment provides continuous learning and development opportunities, especially as new tools and standards are adopted.
What are the key skills and qualifications needed to thrive in software validation?
To thrive as a Software Validation professional, you need a solid understanding of software testing principles, validation methodologies, and quality assurance processes, often complemented by a degree in computer science, engineering, or a related field. Familiarity with test automation tools (such as Selenium or JUnit), validation frameworks, and compliance standards like ISO or FDA regulations is highly valuable. Attention to detail, analytical thinking, and effective communication skills help professionals excel in this role. These competencies are essential to ensure the reliability, safety, and compliance of software products before they reach end users.
What is software validation?
A Software Validation job involves ensuring that software meets its intended purpose and complies with regulatory or industry standards. Professionals in this role design and execute test plans, document findings, and work closely with developers to resolve issues. This position is common in industries like healthcare, automotive, and finance, where software reliability and compliance are critical. The goal is to verify that software operates correctly, safely, and effectively before release.

Full-time
Re-posted 17 days ago
Job description
NTT DATA is a global innovator of business and technology services, seeking an experienced Instrument Software Validation Analyst to join their team in Cincinnati, Ohio. This role focuses on ensuring that laboratory, manufacturing, and embedded software systems operate reliably and in compliance with regulatory requirements, while maintaining validated systems through structured validation processes.
Responsibilities:
• 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
Qualifications:
Required:
• Education: Bachelor's degree in Computer Science, Engineering, Life Sciences, or related field
• Experience: 2–5+ years of experience in Computer System Validation (CSV) or software validation in regulated industries (pharmaceutical, biotech, or medical devices)
• Regulatory Knowledge: 5+ years of strong understanding of: FDA, EMA, and GMP regulations, 21 CFR Part 11, GAMP 5 guidelines, Data integrity principles
• Technical Expertise: 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
• Core Competencies: 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
Preferred:
• Experience in global regulatory environments
• Exposure to instrument software in laboratory or manufacturing settings
• Knowledge of SOP migration and system lifecycle management
Company:
NTT DATA, Inc. is a trusted global innovator of business and technology services. Founded in 1988, the company is headquartered in Plano, USA, with a team of 10001+ employees. The company is currently Late Stage.