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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

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 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

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

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

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

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

Independent Verification & Validation (IV&V) Principal Engineer

Westinghouse Electric Company LLC

Warrendale, Oregon, USA

Full-time

Are you interested in being part of an innovative team that supports Westinghouse's mission to provide clean energy solutions? At Westinghouse, we recognize that our employees are our most valuable asset and we seek to identify, attract and recruit the most qualified talent while recognizing and encouraging the value of diversity in the global workplace. About the role: We are seeking an experienced Principal Engineer to join our Independent Verification and Validation (IV&V) group supporting

Computer System Validation Engineer

Katalyst Healthcares and Lifesciences

Libertyville, Illinois, USA

Full-time

Responsibilities: The Manufacturing IT Systems Quality & Compliance Specialist- Cell Therapy Manufacturing Systems supports the successful operation of manufacturing and business functions at Libertyville site through interaction with internal team members, peer and higher-level customers as well as external service providers. The individual is responsible for the development of and adherence to system governance procedures. The individual supports multiple IT projects/systems and ongoing work a

Validation Engineer

Katalyst Healthcares and Lifesciences

Summit, New Jersey, USA

Full-time

Position Overview: The CSV Engineer supports the successful implementation of manufacturing and laboratory equipment and computerized systems at multi-use sites through interaction with internal customers and external service providers. The incumbent in this role, contributes to the completion of milestones associated with equipment qualification and systems validation. With minimum supervision and given general instructions, this individual carries out routine tasks and functions and uses basic

Engineer - Verification and Validation Lead

Trimble Mobile Solutions

Dayton, Ohio, USA

Full-time

Your Title: Engineer: Verification and Validation Lead Job Location: Dayton, OH Our Department: CTCT Caterpillar Trimble Control Technologies (CTCT) is a joint venture between Caterpillar and Trimble whose purpose is to transform the way heavy equipment customers shape the world with solutions that differentiate Caterpillar and Trimble. About Trimble Trimble is an exciting, entrepreneurial company, with a history of exceptional growth coupled with a disciplined and strategic focus on being

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