senior validation lead Jobs

81 - 100 of 267 Jobs

System Validation EngineerJob Title - System Validation Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

•

Santa Clara, California, USA

Full-time

Responsibilities: Develop, implement, and maintain software quality assurance processes for non-product software used in medical device development. Ensure adherence to regulatory standards (FDA, ISO 13485, IEC 62304) and industry best practices for non-product software. Support audits and inspections by regulatory bodies, ensuring that non-product software systems comply with quality and documentation standards. Ensure computerized systems are appropriately validated Assessment of applicabi

Automotive Validation Technician - Environmental TestingJob Title - Automotive Validation Technician - Environmental Testing

BayOne SolutionsCompany Name - BayOne Solutions

•

Torrance, California, USA

Contract

Must Have Ability to work hands onAble to read electrical schematicsElectrical testing/troubleshooting experienceExperience with High Voltage (800 1000V)Experience with Microsoft OfficeHarness Fabrication Nice To Have Build Technician ExperienceMachine shop toolsSolderingTechnical degree in electronics Responsibilities: Set up and run development and validation tests (thermal, vibration, humidity, corrosion, electrical performance) on High Voltage Power ElectronicDocument test results and prov

Computer System Validation EngineerJob Title - Computer System Validation Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

•

San Juan, San Juan, Puerto Rico

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.

Validation - Project ManagerJob Title - Validation - Project Manager

Futran SolutionsCompany Name - Futran Solutions

•

Seattle, Washington, USA

Full-time

Job Description: Location: Seattle-Dexter, WA*Hybrid Top Skills: - Experience in the Biotech/Cell Therapy industry Preferred - PMP Experience Preferred - Experience with Smartsheets, Tableau, and MS Projects - Strong organizational skills, ability to multi-task and work in a dynamic, fast paced environment. The Project Manager is closely partnered with the GMS&T Leader to enable effective execution of strategy and plans. The scope of responsibilities of the Project Manager fall into 4 general c

SAP Data Validation Analyst - Finance FICOJob Title - SAP Data Validation Analyst - Finance FICO

TEKsystems c/o Allegis GroupCompany Name - TEKsystems c/o Allegis Group

•

Loveland, Colorado, USA

Full-time

TEKsystems has a 12 month contract role for an SAP Data Validation Analyst (Finance). Ideally the client would like resources based in Colorado that could commute occasionally to site -Location: Loveland, CO but they are open to a remote resource. Core Business Problem: Data reconciliation failures between SAP ? HANA ? Power BI causing millions in quarterly audit discrepancies with their auditor. Need someone to eliminate the bottleneck where accounting staff constantly mediate between SAP cons

CSV Validation EngineerJob Title - CSV Validation Engineer

Katalyst Healthcares and LifesciencesCompany Name - 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 Support EngineerJob Title - Validation Support Engineer

Katalyst Healthcares and LifesciencesCompany Name - 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

Computer System Validation (CSV) EngineerJob Title - Computer System Validation (CSV) Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

•

Remote or Massachusetts, USA

Full-time

Responsibilities: Lead and execute CSV activities across GxP-regulated systems (LIMS, MES, ERP, etc. uthor and maintain validation deliverables: URS, FS, DS, IQ, OQ, PQ, and traceability matrices. Ensure systems comply with 21 CFR Part 11, EU Annex 11, and GAMP 5. Support system implementations, upgrades, and periodic reviews. Collaborate with QA, IT, and business users to drive validation strategy. Participate in audits and inspections to demonstrate compliance. Requirements: Bachelor's degree

Computer System Validation EngineerJob Title - Computer System Validation Engineer

Katalyst Healthcares and LifesciencesCompany Name - 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

Associate Manager, Data Validation EngineerJob Title - Associate Manager, Data Validation Engineer

Takeda pharmaceuticalCompany Name - Takeda pharmaceutical

•

Boston, Massachusetts, 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 Pursuant to Section 20 C.F.R. 656.10, you are hereby notified that an application for Alien Employment Certification will be filed by

Validation Support EngineerJob Title - Validation Support Engineer

Katalyst Healthcares and LifesciencesCompany Name - 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

Validation EngineerJob Title - Validation Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

•

Summit, New Jersey, USA

Full-time

Responsibilities: Maintains all qualified and validated equipment and systems in compliance with policies, guidelines and procedures. Develops protocols, and associated reports while adhering to a change management process. Supports the execution of equipment qualifications and validation protocols. Supervises vendors for qualification functions. Supports equipment qualification and systems validation activities. Configures and documents the configuration of computerized systems. Develops

CSV Engineer (Computer System Validation)Job Title - CSV Engineer (Computer System Validation)

Katalyst Healthcares and LifesciencesCompany Name - 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 EngineerJob Title - System Validation Engineer

SUPERMICRO COMPUTER INCCompany Name - SUPERMICRO COMPUTER INC

•

San Jose, California, USA

Full-time

Job Req ID: 26864 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

Validation EngineerJob Title - Validation Engineer

Salas O'Brien Engineers IncorporatedCompany Name - Salas O'Brien Engineers Incorporated

•

Houston, Texas, USA

Full-time

At Salas O'Brien we tell our clients that we're engineered for impact. This passion for making a difference applies just as much to our team as it does to our projects. That's why we're committed to living our values every day: inspiring, achieving, and connecting as shared owners of our success with a focus on a sustainable future. Building for the long-term means that all of our team members can expect to work on amazing projects with a people-first approach to problem solving. It also means

Validation EngineerJob Title - Validation Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

•

Rockford, Illinois, USA

Full-time

Responsibilities: Perform validation activities to ensure compliance with government and customer requirements. Prepare and execute validation protocols (IOQ, OQ/PQ) and related documentation for new customer/product/system launches. Maintain existing validated processes, coordinating internal and customer approvals as needed. Ensure validation documentation is complete, accurate, and properly closed, including organizing and coordinating multiple approvals. Assist in the change control pro

Verification and Validation EngineerJob Title - Verification and Validation Engineer

Booz Allen HamiltonCompany Name - Booz Allen Hamilton

•

Clearfield, Utah, USA

Full-time

Job Number: R0221685 Verification and Validation Engineer The Opportunity: Are you looking for an opportunity to combine your technical skills with big picture thinking to make an impact in national security? You understand your customer's environment and how to develop the right systems for their mission. Your ability to translate real-world needs into technical specifications makes you an integral part of delivering a customer focused engineering solution. When a user tries new sof tware, they

Principal Verification and Validation EngineerJob Title - Principal Verification and Validation Engineer

BAE SystemsCompany Name - BAE Systems

•

Potomac, Maryland, USA

Full-time

Job Description BAE Systems is seeking a full-time Principal Verification and Validation Engineer to support our work as a prime contractor on a high-profile U.S. Navy weapon system. The candidate will help guide and determine the verification approach for our Systems Engineering team as it incorporates Model Based Systems Engineering (MBSE) tools and methodologies to support the UK TRIDENT Submarine Strategic Weapon System (SWS) program. The ideal candidate would be self-motivated, good at pla

Engineer III, ValidationJob Title - Engineer III, Validation

Thermo Fisher ScientificCompany Name - Thermo Fisher Scientific

•

Remote or Fair Lawn, New Jersey, USA

Full-time

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description When you're part of Thermo Fisher Scientific, you'll do meaningful work, and join a team that values performance, quality and innovation. As part of a successful, growing global organization you will be encouraged to perform at your best. With revenues of more than $40 billion and the largest investment in R&D in the industry, we give our people the resources and chances to create significant contributions to the

Staff Integration Engineer, Verification and ValidationJob Title - Staff Integration Engineer, Verification and Validation

RivianCompany Name - 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