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Sr. CSV Validation Engineer

Katalyst Healthcares and Lifesciences

New Brunswick, New Jersey, USA

Full-time

Responsibilities: Review computerized systems validation documents such as: Requirements Specification, Design Specification, CSV Risk Assessment, Test Plans, Test Summary Reports, Data Migration Plan, Pre/Post Executed Test Scripts, Traceability Matrix. Release to Production Statements Direct and review testing Provide guidance on quality issues that affect the integrity of the data, or the system Obtain and respond to QA review. Participate in establishing standard quality and validation pract

Sr. CSV Validation Engineer

Katalyst Healthcares and Lifesciences

Lawrence Township, New Jersey, USA

Full-time

Roles & Responsibilities: 8-10+ Years of Overall IT Experience Review computerized systems validation documents such as: Requirements Specification, Design Specification, CSV Risk Assessment, Test Plans, Test Summary Reports, Data Migration Plan, Pre/Post Executed Test Scripts, Traceability Matrix. Release to Production Statements Direct and review testing Provide guidance on quality issues that affect the integrity of the data, or the system Obtain and respond to QA review. Participate in

CSV Validation Engineer

Katalyst Healthcares and Lifesciences

Austin, Texas, USA

Full-time

Roles and Responsibilities: Strong writing, grammar, and editing abilities to create clear and concise documentation. bility to adapt writing style to various audiences (e.g., end users, technical teams, or regulatory bodies). Document Design and Formattingo Proficiency with documentation tools. Knowledge of design principles to create well-structured documents (manuals, user guides, SOPs, etc.). Version Controlo Familiarity with tools like Git, SVN, or SharePoint to manage document revisions a

Validation Engineer

Katalyst Healthcares and Lifesciences

Raynham, Massachusetts, USA

Full-time

Responsibilities: Ask candidates if they have validated equipment and what type of equipment they have validated. Mechanical/manufacturing experience. Writing and executing validation protocols. CSV is nice to have, but if the candidate has done that exclusively it will not work. Requirements: A minimum of a Bachelor's degree in Engineering is required. Minimum of 1-3 years' experience in medical device manufacturing, Bio/pharma is also good Develop and implement processes to support the

Sr. Validation Engineer (CSV)

Katalyst Healthcares and Lifesciences

California, USA

Full-time

Responsibilities: Creates Computer System Validation (CSV) deliverables (Validation Plan, Requirements Specifications, Protocols, Summary Reports, Trace Matrices, SOPs, Risk assessments). Collaborates with Business Users, System Owner, Global IT teams and Business Analysts to define validation requirements and plans. Providing leadership, oversight, and training related to validation activities to multi-functional teams. Generate and execute validation protocols (IQ/OQ/PQ) using Good Documentati

Staff Integration Engineer, Verification and Validation

Rivian

Irvine, California, USA

Full-time

About Rivian Rivian is on a mission to keep the world adventurous forever. This goes for the emissions-free Electric Adventure Vehicles we build, and the curious, courageous souls we seek to attract. As a company, we constantly challenge what's possible, never simply accepting what has always been done. We reframe old problems, seek new solutions and operate comfortably in areas that are unknown. Our backgrounds are diverse, but our team shares a love of the outdoors and a desire to protect it

Validation Lead

TechDigital Corporation

King of Prussia, Pennsylvania, USA

Contract, Third Party

Computer System Validation, Computed system assurance, GAMP, GxP risk assessments, Change Management 10+ years' Experience in Validating systems and Experienced in CSV activities in GxP related applications like SAP Systems, Product Serialization systems, MES systems Perform review for GxP systems to ensure compliance with regulatory requirements Working knowledge on end-to-end validation of GxP applications and is able to perform document/process Compliance Analysis Adept with Agile and Waterf

Validation Support Engineer

Katalyst Healthcares and Lifesciences

Boston, Massachusetts, USA

Full-time

Job Description: We are seeking an experienced Validation Support Engineer to lead validation activities for Beckhoff Twin CAT PLC-controlled systems in a 24/7 GMP-regulated manufacturing environment. The role focuses on ensuring compliance with FDA regulations (21 CFR Part 11, 210, 211, 820), GAMP5 methodologies, and internal quality standards. Responsibilities: Develop/update Validation Plans (VP) and Master Validation Plans (MVP). Lead GxP risk assessments for system changes. Author and

Bluetooth Software Validation Engineer

Tesla Motors

Palo Alto, California, USA

Full-time

Tesla is seeking a highly motivated Bluetooth Software Validation Engineer who will be part of Wireless Connectivity team that is focused on delivering high quality Wireless technologies on various Tesla vehicle platforms (S, 3, X, Y, Cybertruck, and Cybercab). In this role, you will be responsible for the architecture, design, and validation of Bluetooth solutions for telematics systems. The position requires close collaboration with cross functional teams and external suppliers and partners, w

Computer System Validation Engineer

Katalyst Healthcares and Lifesciences

Remote or New Jersey, USA

Full-time

Roles & Responsibilities: Full lifecycle validation for all applicable computerized systems, ensuring they are designed, validated, operated and retired in compliance with GxP regulation and computer system validation (CSV) guidance. Compiling and maintaining accurate CSV documentation, ensuring full traceability throughout system lifecycles. Compliance Analysis, Validation Planning, Risk Assessments Test planning and strategy creation and execution of test protocols, scripts and reports. V

Validation Engineer

AdientOne LLC

California, USA

Contract

Role: Validation Engineer Location: Santa clara USA 95054| Onsite Duration: 6+ months contract Job Description: In this role, this engineer will be part of a highly technical team that develops test plans, completes functional & electrical validation, & debugs issues for memory controller, NOC & other silicon interface features. Executes electrical & functional test plans for client processors using hardware & software validation tools, oscilloscopes, & logic analyzers. Debug of electrical &

Verification and Validation R&D Engineer

Katalyst Healthcares and Lifesciences

Marlborough, Massachusetts, USA

Full-time

Responsibilities: Designs, develops, and implements cost-effective methods of testing and troubleshooting systems and equipment. Prepares test and diagnostic plans/programs and infrastructure, designs test fixtures and equipment, and completes specifications and procedures for new products. Plans the labor, schedules, and equipment required for testing and evaluating standard and special devices. Lead and execute Verification and Validation (V&V) activities for disposable kit development. De

Senior Engineer Computerized System Validation

Takeda pharmaceutical

Social Circle, Georgia, USA

Full-time

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description About the Role: The Computerized Systems Validation Engineering, is responsible for leading, managing, and performing engineering op

Validation Engineer

Katalyst Healthcares and Lifesciences

Schaumburg, Illinois, USA

Full-time

Responsibilities: Strong understanding of regulations and guidance related to Computer System Validation principles and Quality Management Systems (21CFR Part 11, GAMP- 5, EU Annex 11 and other relevant regulations). Bachelor's degree or equivalent experience in computer science, information technology, or a related field. High degree of proficiency in Microsoft Office Suite and Smartsheet. Detail-oriented with a strong analytical mindset and problem-solving capabilities. Excellent project

Internship, Wireless Connectivity Software Validation Engineer, Electronic Devices(Fall 2025)

Tesla Motors

Palo Alto, California, USA

Full-time

Consider before submitting an application: This position is expected to start around August or September 2025 and continue through the Fall term (ending approximately December 2025) or continuing into Winter/Spring 2026 if available and there is an opportunity to do so. We ask for a minimum of 12 weeks, full-time and on-site, for most internships. Our internship program is for students who are actively enrolled in an academic program. entry level candidates seeking employment after graduation a

CSV Engineer (Computer System Validation)

Katalyst Healthcares and Lifesciences

Kansas City, Missouri, USA

Full-time

Responsibilities: Validation documentation Authoring (validation plans, user requirements specifications, risk assessment, IQ-OQ-PQ protocols, trace matrix and summary reports) Experience in validating GMP Lab systems and Equipment. Responsible for assuring a system/application meets its requirements as outlined in system specification (URS/FRS) per process defined in the Validation Plan for the project. Identify and escalate, as necessary project risks and issues to the CSVC Manager. Engage

System Validation Engineer

SUPERMICRO COMPUTER INC

San Jose, California, USA

Full-time

Job Req ID: 26975 About Supermicro: Supermicro is a Top Tier provider of advanced server, storage, and networking solutions for Data Center, Cloud Computing, Enterprise IT, Hadoop/ Big Data, Hyperscale, HPC and IoT/Embedded customers worldwide. We are the #5 fastest growing company among the Silicon Valley Top 50 technology firms. Our unprecedented global expansion has provided us with the opportunity to offer a large number of new positions to the technology community. We seek talented, pass

Senior Systems Engineer, AI Safety Validation

Nuro Inc.

Mountain View, California, USA

Full-time

Who We Are Nuro exists to better everyday life through robotics. Founded in 2016, Nuro has spent eight years developing autonomous driving (AD) technology and commercializing AD applications. The Nuro Driver is our world-class autonomous driving system that combines AD hardware with our generalized AI-first self-driving software. Built to learn and improve through data, the Nuro Driver is one of the few driverless autonomous technologies on public roads today. Nuro has raised over $2B in capi

Validation Support Engineer

Katalyst Healthcares and Lifesciences

Johns Creek, Georgia, USA

Full-time

Roles & Responsibilities: Validation Planning: Develop/update Master Validation Plans (MVP) and individual Validation Plans (VP) for system changes. Required: Proven expertise in CSV (Computer System Validation) methodologies (e.g., GAMP5), FDA regulations (21 CFR Part 11, 210, 211, 820 as applicable), and validation of automated manufacturing/control systems. Experience validating PLC-based systems (Beckhoff Twin CAT experience is a significant plus). Responsibilities: Perform tasks under S

Sr. Instrument Verification and Validation Engineer

Katalyst Healthcares and Lifesciences

Rochester, New York, USA

Full-time

Responsibilities: Designing and implementing software of embedded devices and systems. Designing, developing, coding, testing, and debugging system software. Develop Requirements based manual test procedures. Access requirements for testability and determine best test approach. Compile and analyze test results. Document and manage system software defects. Participate in regular scheduling and team meetings. Participate in regular off hour meetings with partner in China. Understand projec