thermal validation engineer Jobs

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ATE Software Validation Engineer

Katalyst Healthcares and Lifesciences

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Skaneateles, New York, USA

Full-time

Roles & Responsibilities: Lead software validation efforts for ATE systems used in testing infusion pumps, patient monitors, or diagnostic devices. Develop validation protocols, test plans, scripts, and reports in alignment with FDA 21 CFR Part 820, Part 11, and ISO 13485. Collaborate with cross-functional teams (R&D, Quality, Manufacturing) to define software validation requirements and risk-based testing strategies. Perform IQ/OQ/PQ for ATE systems and ensure traceability from requirements
Posted 1 day ago | Updated 7 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 60+ days ago | Updated 7 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 60+ days ago | Updated 6 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 60+ days ago | Updated 7 hours ago

CSV Engineer (Computer System Validation)

Katalyst Healthcares and Lifesciences

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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
Posted 60+ days ago | Updated 7 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 2 days ago

Validation Engineer

Katalyst Healthcares and Lifesciences

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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, functions, and uses basi
Posted 60+ days ago | Updated 6 hours ago

Computer System Validation (CSV) Engineer

Katalyst Healthcares and Lifesciences

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Remote or Massachusetts, USA

Full-time

Responsibilities: Lead and execute CSV activities across GxP-regulated systems (LIMS, MES, ERP, etc. Author 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
Posted 27 days ago | Updated 7 hours ago

Validation Engineer

Katalyst Healthcares and Lifesciences

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North Haven, Connecticut, USA

Full-time

Responsibilities: As a Validation Engineer within the Mold & Capital Tooling Organization, you'll play a pivotal role on a global enterprise team, collaborating with various sites around the world. In this role, you'll facilitate or perform critical validation & qualification activities, ensuring the seamless release of high-quality injection molded components that drive our mission forward. Ensure proper qualification and validation of suppliers and their processes, ensuring supplier meets th
Posted 8 days ago | Updated 6 hours ago

Validation Engineer

Katalyst Healthcares and Lifesciences

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Santa Clara, California, USA

Full-time

Roles & Responsibilities: Software quality assurance or software validation. Preferably within the medical device industry. Strong knowledge of FDA 21 CFR Part 820, ISO 13485, IEC 62304. Experience in non-product software validation. Includes tools for development, testing, maintenance. Deep understanding of quality standards and regulatory requirements: FDA 21 CFR Part 820. ISO 13485. IEC 62304. Software quality assurance. Software validation. Non-product software tools (for testing
Posted 10 days ago | Updated 6 hours ago

Senior Staff GPU Validation and Emulation Engineer

Qualcomm Technologies

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San Diego, California, USA

Full-time

Company: Qualcomm Technologies, Inc. Job Area: Engineering Group, Engineering Group > GPU ASICS Engineering General Summary: As a leading technology innovator, Qualcomm pushes the boundaries of what's possible to enable next-generation experiences and drives digital transformation to help create a smarter, connected future for all. As a Qualcomm GPU Engineer, you may architect, design, implement, verify, and/or optimize the performance and power of GPU cores. Qualcomm Engineers collaborate wi
Posted 5 days ago | Updated 7 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 7 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 59 days ago | Updated 6 hours ago

System Validation Engineer

Katalyst Healthcares and Lifesciences

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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
Posted 19 days ago | Updated 6 hours ago

Verification and Validation R&D Engineer

Katalyst Healthcares and Lifesciences

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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
Posted 60+ days ago | Updated 6 hours ago

Sr. Validation Engineer (CSV)

Katalyst Healthcares and Lifesciences

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Muskegon, Michigan, USA

Full-time

Roles & Responsibilities: The Validation Specialist carries out quality control checks on engineering project work under the supervision of the Validation Lead, Automation Lead and Project Manager. Perform initial CSV at client site for systems including DeltaV, Historian, MES, ABB as well as other DCS and OT systems. They will review and approve risk assessment link to CSV of systems. Collaborate with the other departments, within their respective areas of responsibility for Change Managemen
Posted 17 days ago | Updated 6 hours ago

Computer System Validation Engineer

Katalyst Healthcares and Lifesciences

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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
Posted 60+ days ago | Updated 7 hours ago

Sr. Instrument Verification and Validation Engineer

Katalyst Healthcares and Lifesciences

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Rochester, New York, USA

Full-time

Responsibilities: Designing and implementing software of embedded devices and systems. Designing, developing, coding, testing, and debugging system software. Develop Requirements based manual test procedures. Access requirements for testability and determine best test approach. Compile and analyze test results. Document and manage system software defects. Participate in regular scheduling and team meetings. Participate in regular off hour meetings with partner in China. Understand projec
Posted 53 days ago | Updated 6 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 7 hours ago

Sr. CSV Validation Engineer

Katalyst Healthcares and Lifesciences

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Lawrence Township, New Jersey, USA

Full-time

Roles & Responsibilities: 8-10+ Years of Overall IT Experience Review computerized systems validation documents such as: Requirements Specification, Design Specification, CSV Risk Assessment, Test Plans, Test Summary Reports, Data Migration Plan, Pre/Post Executed Test Scripts, Traceability Matrix. Release to Production Statements Direct and review testing Provide guidance on quality issues that affect the integrity of the data, or the system Obtain and respond to QA review. Participate in
Posted 60+ days ago | Updated 6 hours ago