Data validation Jobs

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Validation Engineer

Katalyst Healthcares and Lifesciences

•

Framingham, Massachusetts, USA

Full-time

Responsibilities: Execute validation activities in computerized system and ensure 21 CFR part 11 compliance. Knowledge in GAMP. Preparing trace matrix to ensure requirements are tested to meet the software intended use. Preparing risk assessment for functional requirements and providing testing. strategy, implementing technical & procedural controls as part of mitigation. Preparing SOP/Work instruction for equipment and software-based systems. Requirements: 6 to 8 years of Non-Product Software
Posted 20 hours ago | Updated 8 hours ago

Validation Engineer

Katalyst Healthcares and Lifesciences

•

Hartford, Connecticut, USA

Full-time

Responsibilities: Functional requirement specification, function risk assessment, installation qualification, operational. Qualification, performance qualification, traceability matrix, project release notes, system certification summary). Execute validation activities in computerized system and ensure 21 CFR part 11 compliance. Knowledge in GAMP. Preparing risk assessment for functional requirements and providing testing strategy, implementing technical & procedural controls as part of mitigat
Posted 20 hours ago | Updated 8 hours ago

Senior Validation Engineer

Katalyst Healthcares and Lifesciences

•

Pomona, California, USA

Full-time

Roles & Responsibilities: 6 to 8 years of Non-Product Software Validation engineer with Manufacturing background (Medical devices or Diagnostics). Non-Product software validation for Manufacturing Equipment's as per Regulatory standards (FDA, ISO requirements). Prepare, review functional requirements, design and testing documents. Prepare, review of SLC deliverables (Validation plan, change requests, User requirements specification, Functional requirement specification, function risk assessment,
Posted 20 hours ago | Updated 8 hours ago

Senior Validation Engineer

Katalyst Healthcares and Lifesciences

•

Pomona, California, USA

Full-time

Responsibilities and requirements: 6 to 8 years of Non-Product Software Validation engineer with Manufacturing background (Medical devices or Diagnostics). Non-Product software validation for Manufacturing Equipment's as per Regulatory standards (FDA, ISO requirements). Prepare, review functional requirements, design and testing documents. Prepare, review of SLC deliverables (Validation plan, change requests, User requirements specification, Functional requirement specification, function risk a
Posted 20 hours ago | Updated 8 hours ago

Computer System Validation Engineer

Katalyst Healthcares and Lifesciences

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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
Posted 20 hours ago | Updated 8 hours ago

CSV Validation Engineer

Katalyst Healthcares and Lifesciences

•

Rockville, Maryland, USA

Full-time

Responsibilities: Our client is currently in the process of starting up a clinical cell therapy site with clean rooms. They are in the commissioning phase and validating documentation and processes for the utilities, facilities, computer systems, and cleanroom environments to meet the requirements for cell-based therapies. The site will be designed to support the production of cell therapies, which necessitates adherence to GMP, regulatory compliance, and the implementation of validation and com
Posted 20 hours ago | Updated 8 hours ago

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
Posted 20 hours ago | Updated 8 hours ago

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
Posted 20 hours ago | Updated 8 hours ago

FMS Verification & Validation Engineer- Aerospace Industry

DBSI Services

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Remote or Cedar Rapids, Iowa, USA

Full-time

Benefits: 401(k) 401(k) matching Relocation bonus Position: FMS Verification & Validation Engineer Location: Remote About the Role: We are seeking a skilled Verification Engineer with expertise in Flight Management Systems (FMS) The ideal candidate will have experience in verification and validation (V&V) processes for avionics systems, with a strong background in display, navigation, and application systems within FMS Skill Matrix: Yrs. In Flight Management Systems Yrs. In verification and v
Posted 60+ days ago | Updated 8 hours ago

Validation Engineer

Katalyst Healthcares and Lifesciences

•

Tucson, Arizona, USA

Full-time

Responsibilities: Designs and drafts validation sampling and testing plan/protocols. Executes and reports on validation studies such as Process Validation, Cleaning Validation, CSV, Commissioning, IQ, OQ and PQ studies. Resolve technical issues encountered during study execution. Track and expedite the review and sign-off of qualification documentation. Support execution of validation activities. Interact with individuals from different departments to plan, execute, and complete qualification a
Posted 20 hours ago | Updated 8 hours ago

Validation Engineer

Katalyst Healthcares and Lifesciences

•

Tucson, Arizona, USA

Full-time

Responsibilities: Designs and drafts validation sampling and testing plan/protocols. Executes and reports on validation studies such as Process Validation, Cleaning Validation, CSV, Commissioning, IQ, OQ and PQ studies. Resolve technical issues encountered during study execution. Track and expedite the review and sign-off of qualification documentation. Support execution of validation activities. Interact with individuals from different departments to plan, execute, and complete qualification a
Posted 20 hours ago | Updated 8 hours ago

Corporate Automation Computer System Validation Engineer - API Drug Substance

Eli Lilly and Company

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Indianapolis, Indiana, USA

Full-time

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined
Posted 2 days ago | Updated 8 hours ago

Validation Engineer

Katalyst Healthcares and Lifesciences

•

King of Prussia, Pennsylvania, USA

Full-time

Responsibilities: Designing and executing validation including support of computer system validation protocols to ensure consistency of data production and compliance with client's quality standards (including internal ISPE referenced guidelines, client procedures, and 21 Code of Federal Regulations Part 2XX and 8XX level standards which apply to the equipment and product being validated). Ensuring product and process development activities have all necessary validation and supporting justifica
Posted 20 hours ago | Updated 8 hours ago

Computer System Validation Engineer

Katalyst Healthcares and Lifesciences

•

Scottsdale, Arizona, USA

Full-time

Responsibilities: Execute and lead the validation of computer systems, ensuring compliance with 21 CFR Part 11, FDA regulations, and cGMP regulations. Develop, review, and approve validation documents, including validation plans, test scripts, and final reports. Coordinate and conduct validation activities in accordance with project timelines and business objectives. Implement and manage document control processes and systems. Evaluate and recommend improvements to existing systems and processe
Posted 20 hours ago | Updated 8 hours ago

CSV Engineer (Computer System Validation)

Katalyst Healthcares and Lifesciences

•

Kansas City, Missouri, USA

Full-time

Roles & 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 Manage
Posted 20 hours ago | Updated 8 hours ago

Senior Systems Engineer, AI Safety Validation

Nuro Inc.

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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
Posted 60+ days ago | Updated 8 hours ago

Senior Staff Integration Engineer, Verification & Validation

Rivian

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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
Posted 60+ days ago | Updated 8 hours ago

Software Validation Engineer, Simulation Infrastructure, High Voltage Systems

Tesla Motors

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Palo Alto, California, USA

Full-time

As a Validation Engineer on the High Voltage Systems team, you will have the opportunity to develop validation plans and automation tooling to help accelerate the development of new products and features for Tesla vehicles. Through the lens of validation, you will have the opportunity to assist in the bringup of new products and features, working closely with firmware developers to ensure the quality of Tesla products. Join a dedicated and highly skilled team of engineers and you will have oppor
Posted 60+ days ago | Updated 7 hours ago

Sr. Validation Engineer (CSV)

Katalyst Healthcares and Lifesciences

•

California, USA

Full-time

Responsibilities: Create and execute Computer System Validation (CSV) deliverables (Validation Plans, Protocols, Reports, Trace Matrices, SOPs). Collaborate with Business Users, System Owners, IT teams, and Analysts to define validation requirements. Provide leadership and training in validation activities. Generate IQ/OQ/PQ protocols using Good Documentation Practices (GDP). Ensure compliance with quality system elements for computer systems/software testing. Perform gap assessments and remedia
Posted 20 hours ago | Updated 8 hours ago

Sr. Computer system Validation Engineer

Katalyst Healthcares and Lifesciences

•

Saint Joseph, 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. Enga
Posted 20 hours ago | Updated 8 hours ago