Senior Validation Analyst Jobs

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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

Space Vehicle Verification and Validation Lead - Blue Ring

Blue Origin, LLC

Seattle, Washington, USA

Full-time

Application close date: Applications will be accepted on an ongoing basis until the requisition is closed. At Blue Origin, we envision millions of people living and working in space for the benefit of Earth. We're working to develop reusable, safe, and low-cost space vehicles and systems within a culture of safety, collaboration, and inclusion. Join our team of problem solvers as we add new chapters to the history of spaceflight! The role is part of the In-Space Systems business unit, which is

Validation Engineer

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

Associate Manager, Data Validation Engineer

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 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

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: 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 Engineer

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 Engineer

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 Engineer

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

Engineer III, Validation

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

Principal Verification and Validation Engineer

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

Validation Engineer

Katalyst Healthcares and Lifesciences

Warren, 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 calibration, equipment qualification and validation activities. Configures and documents the configuration of computerized systems. Dev

Validation Lead, SAP S4 HANA

Katalyst Healthcares and Lifesciences

Remote or New Jersey, USA

Full-time

Responsibilities: Lead the validation team in a strategic, risk-based approach that optimizes legacy Computer System documentation, CSA strategies and strong SAP ECC->S/4 HANAconversion knowledge to successfully deliver a validated system meeting all project requirements. Review, approval, and processing of Computer System Lifecycle deliverables including: User Requirements, Specifications, Test Plans, IQ, OQ, PQ Test Scripts, User Guides. Fostering of effective relationships with implementati

Principal Validation Engineer

Johnson & Johnson

Danvers, Massachusetts, USA

Full-time

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn m

Ethernet NIC Software and Validation Engineer

Broadcom Corporation

Irvine, California, USA

Full-time

Please Note: 1. If you are a first time user, please create your candidate login account before you apply for a job. (Click Sign In > Create Account) 2. If you already have a Candidate Account, please Sign-In before you apply. Job Description: Broadcom is a leading supplier of high speed, highly optimized, highly integrated ASICs to the Cloud and Enterprise Data Center markets. In the Network Switching and Controller Group, we are operating at the cutting edge of the market, creating high pe

Principal Engineer, Validation

Novo Nordisk Inc

Bloomington, Indiana, USA

Full-time

About the Department At Novo Nordisk, we want to make a difference. For more than 100 years, we have led the way in diabetes care. Being part of Novo Nordisk allows our employees to embark on life-changing careers, and the opportunity to help improve the quality of life for millions of people around the world. Our Bloomington, Indiana site is a state-of-the-art facility where we have an integrated model from process and formulation to clinical and commercial biomanufacturing and drug product f

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

Verification & Validation Engineer

Katalyst Healthcares and Lifesciences

Plymouth, Minnesota, USA

Full-time

Job description: As a member of the Vantive Acute Therapies Verification and Validation engineering team, you would be responsible for supporting product verification, validation, and compliance test activities on electrical and mechanical medical device components/systems. Your expertise will be applied to all levels of product development from component prototypes to final system design. This will include developing, executing, and validating test methods/creating associated documentation. Int

Data Integrity QA Validation Engineer

Katalyst Healthcares and Lifesciences

Rensselaer, New York, USA

Full-time

Responsibilities: Participate on teams of internal resources in delivery of CSV projects. Author functional requirements specifications that are complete, accurate, and testable. Author system Risk Assessments, 21 CFR 11 Assessments, and Annex 11 Assessments. Author Validation Plans and Validation Reports. Author validation and verification testing protocols/scripts (i.e., IQ, OQ, PQ) and Trace Matrices. Experience in validation at least two of these computer system categories: automation contro