pharma validation engineer Jobs

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Senior Engineer Computerized System Validation

Takeda pharmaceutical

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Social Circle, Georgia, 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 About the Role: The Computerized Systems Validation Engineering, is responsible for leading, managing, and performing engineering op
Posted 18 days ago | Updated 4 hours ago

Validation Engineer

Katalyst Healthcares and Lifesciences

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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
Posted 6 days ago | Updated 5 hours ago

Computer System Validation Engineer

Katalyst Healthcares and Lifesciences

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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.
Posted 60+ days ago | Updated 5 hours ago

Sr. Instrument Verification and Validation Engineer

Katalyst Healthcares and Lifesciences

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Rochester, New York, USA

Full-time

Job Description: Client is seeking a Verification and Validation SR Engineer to help with formal verification and validation of complex medical devices under the regulations of the FDA. The individual will be part of an engineering team that is responsible for requirements based manual test case design and execution of test procedures in a BL2 lab environment. The team is highly collaborative and will require regular interactions in formal reviews, test planning activities, and working with so
Posted 17 days ago | Updated 5 hours ago

Validation Support Engineer

Katalyst Healthcares and Lifesciences

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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
Posted 47 days ago | Updated 4 hours ago

System Validation Engineer

SUPERMICRO COMPUTER INC

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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
Posted 26 days ago | Updated 5 hours ago

Principal Engineer, Validation

Novo Nordisk Inc

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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
Posted 15 days ago | Updated 5 hours ago

CSV Validation Engineer

Katalyst Healthcares and Lifesciences

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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
Posted 60+ days ago | Updated 5 hours ago

Bluetooth Software Validation Engineer

Tesla Motors

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Palo Alto, California, USA

Full-time

Tesla is seeking a highly motivated Bluetooth Software Validation Engineer who will be part of Wireless Connectivity team that is focused on delivering high quality Wireless technologies on various Tesla vehicle platforms (S, 3, X, Y, Cybertruck, and Cybercab). In this role, you will be responsible for the architecture, design, and validation of Bluetooth solutions for telematics systems. The position requires close collaboration with cross functional teams and external suppliers and partners, w
Posted 20 days ago | Updated 5 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 60+ days ago | Updated 5 hours ago

Validation Support Engineer

Katalyst Healthcares and Lifesciences

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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
Posted 54 days ago | Updated 4 hours ago

Sr. Validation Engineer (CSV)

Katalyst Healthcares and Lifesciences

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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 60+ days ago | Updated 5 hours ago

Validation Engineer

Katalyst Healthcares and Lifesciences

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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
Posted 39 days ago | Updated 4 hours ago

Principal Validation Engineer

Johnson & Johnson

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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
Posted 38 days ago | Updated 5 hours ago

Engineer III, Validation

Thermo Fisher Scientific

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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
Posted 50 days ago | Updated 5 hours ago

Validation Engineer

Katalyst Healthcares and Lifesciences

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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
Posted 60+ days ago | Updated 5 hours ago

CSV Engineer (Computer System Validation)

Katalyst Healthcares and Lifesciences

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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
Posted 60+ days ago | Updated 5 hours ago

Senior Quantum Systems Validation Engineer

PsiQuantum

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Palo Alto, California, USA

Full-time

Quantum computing holds the promise of humanity's mastery over the natural world, but only if we can build a real quantum computer. PsiQuantum is on a mission to build the first real, useful quantum computers, capable of delivering the world-changing applications that the technology has long promised. We know that means we will need to build a system with roughly 1 million qubits that supports fault tolerant error correction within a scalable architecture, and a data center footprint. By harnes
Posted 45 days ago | Updated 5 hours ago

Staff Integration Engineer, Verification and 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 55 days ago | Updated 4 hours ago

Independent Verification & Validation (IV&V) Principal Engineer

Westinghouse Electric Company LLC

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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
Posted 56 days ago | Updated 5 hours ago