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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

Senior Validation Engineer

Katalyst Healthcares and Lifesciences

Marlborough, Massachusetts, USA

Full-time

Responsibilities: Derive test requirements from the design specifications, define test plan and methodology, estimate effort and resources plan to cover design verification and validation campaign. Establish acceptance criteria, sampling, assess through modeling or qualitative/quantitative testing, evaluate the performance according to URS, SRS (design inputs and outputs). Write test protocol, setup design of experiments, execute tests, analyse results and document reports for design verificati

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

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

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,

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

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

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

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

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

FMS Verification & Validation Engineer- Aerospace Industry

DBSI Services

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

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

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

Corporate Automation Computer System Validation Engineer - API Drug Substance

Eli Lilly and Company

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

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

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

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

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

Senior Staff Integration Engineer, Verification & 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