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Validation Engineer/CSV Engineer

Katalyst Healthcares and Lifesciences

•

Walnut Creek, 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 12 days ago | Updated 4 hours ago

Sr. Electrical Engineer Power Electronics Test & Validation

DynPro Inc.

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San Francisco, California, USA

Contract

Position: Sr. Electrical Engineer Power Electronics Test & Validation Location: SFO, CA Work Mode: 100% Onsite Responsibilities Apply strong understanding of power electronics topologies and control in design and testing.Review schematics, PCB designs, calculations, and simulations for power electronics converters.Conduct verification and validation tests for power electronics systems, ensuring compliance with industry standards and requirements.Perform hands-on testing and troubleshooting of po
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Posted 8 hours ago

System Validation Engineer (DDR3/DDR4)

Cognowiz

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Santa Clara, California, USA

Contract

Job Title: System Validation Engineer (DDR3/DDR4) Job Location: Santa Clara, CA (Onsite) Duration: 12+ months Interview: Onsite Job Description: We are seeking a skilled engineer to support DDR (DDR3/DDR4) bring-up, margining, and characterization activities. The ideal candidate will have hands-on experience in DDR diagnostics, margin testing, and qualification of different DIMMs, as well as strong scripting skills in C and Python. Key Responsibilities Execute DDR3/DDR4 memory bring-up and syste
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Posted 7 days ago

Electrical Power Electronics Test & Validation Engineer

Tranzeal, Inc.

•

Newark, California, USA

Contract

Role: Electrical Power Electronics Test & Validation Engineer Location: Newark, CA (Onsite) Top 3 Hard Skills Required Strong understanding of power electronics topologies and control.Minimum 5 years experience with Strong hands-on and trouble-shooting skills in testing and verification of power electronics systems, including the use of lab equipment (battery simulators, power supplies, E-loads, scope, etc.).Minimum 5 years experience with Strong technical writing and communication skills, wi
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Posted 19 days ago

Sr. Validation Engineer (CSV)

Katalyst Healthcares and Lifesciences

•

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 23 days ago | Updated 4 hours ago

Verification & Validation (V&V) System Engineer, Designer

EXCEL CONSULTANTS

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Remote or El Segundo, California, USA

Contract

Verification & Validation (V&V) System Engineer, Designer Deep dives into component and subsystem designs to develop and define verification approaches, types, levels in a clearly defined RVCM (requirements verification compliance matrix)Collaborating with diverse technical teams such as software, mechanical, modem, and compliance teams to validate expectations for system-level and network-level operations, from concept through executionIntegrating and performing verification of the end-to-end R
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Posted 8 days ago

Lead/Sr Computer System Validation Engineer

Katalyst Healthcares and Lifesciences

•

Muskegon, Michigan, USA

Full-time

Responsibilities: The CSV Lead manages quality control checks on engineering project work. The CSV Lead will have 10 plus years of experience of automation systems computer systems validation in a GMP environment. The CSV Lead will be responsible to assist Client in designing the validation strategy for the overall project and to coordinate production of the required CSV protocols. The CSV Lead will provide leadership to the CSV team members in reviewing CSV protocols for the various streams
Posted 11 days ago | Updated 4 hours ago

Computer Systems Validation Engineer

Katalyst Healthcares and Lifesciences

•

Bethlehem, Pennsylvania, USA

Full-time

Job Description: We're seeking an experienced Computer Systems Validation (CSV) professional to join our team and lead end-to-end validation activities supporting laboratory system upgrades and data integrity initiatives. This role is ideal for someone with a strong background in regulated environments and hands-on experience with modern lab software and instrumentation. This is a short-term contract assignment running through September and requires individuals to work onsite. Responsibilities
Posted 17 days ago | Updated 4 hours ago

Validation Engineer

Katalyst Healthcares and Lifesciences

•

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 16 days ago | Updated 4 hours ago

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 7 days ago | Updated 4 hours ago

Senior Silicon Validation & Prototyping Engineer

Experis

•

Morrisville, North Carolina, USA

Full-time

Job DescriptionOur client, a leader in advanced silicon engineering, is seeking a Senior Silicon Validation & Prototyping Engineer to join their team. As a Senior Silicon Validation & Prototyping Engineer, you will be part of the engineering department supporting cutting-edge hardware platforms. The ideal candidate will have strong problem-solving skills, excellent communication abilities, and a collaborative mindset which will align successfully in the organization. \n \n\nJob Title: Senior Si
Posted 13 days ago | Updated 2 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 33 days ago | Updated 4 hours ago

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 44 days ago | Updated 4 hours ago

Lead Hardware Validation Engineer

Cloud Destinations LLC

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Santa Clara, California, USA

Contract

Job Summary: We are looking for a highly skilled Senior Validation Engineer to lead the testing and validation of semiconductor components, data center hardware, and GPUs. This role requires deep expertise in designing, executing, and analyzing validation tests, as well as hands-on experience with Python scripting for test automation and software testing methodologies. The ideal candidate will play a critical role in ensuring the reliability, performance, and functionality of cutting-edge hardwa
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Posted 20 days ago

Validation Engineer

Katalyst Healthcares and Lifesciences

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Irvine, California, USA

Full-time

Job Description: The Senior Validation Engineer will serve as a subject matter expert in validation, leading critical projects in support of GMP-compliant manufacturing and product development. This role involves strategic planning, execution, and continuous improvement of validation processes across multiple sites, while supporting audits, risk assessments, and global quality initiatives. Responsibilities: Interpret and implement validation requirements based on FDA regulations, corporate stan
Posted 23 days ago | Updated 4 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 43 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 32 days ago | Updated 4 hours ago

Associate Manager, Data Validation Engineer

Takeda pharmaceutical

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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
Posted 28 days ago | Updated 4 hours ago

Software Data Validation Engineer II

Abbott Laboratories

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Milpitas, California, USA

Full-time

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries. Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. Yo
Posted 7 days ago | Updated 7 hours ago

Computer System Validation Engineer

TSR Consulting Services, Inc.

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Bothell, Washington, USA

Contract

Our client, a leading pharmaceutical company, is hiring a Computer System Validation Engineer, on a contract basis. Job ID: 83095 Work Location: Bothell, WA - Hybrid role Summary: The Computer Systems Validation (CSV) Contractor works cross-functionally to lead and execute validation activities for GxP electronic systems and applications. This role is an individual contributor. The CSV Contractor will partner with Business Owners, Technical Owners, and Quality to create and manage validation de
Posted 1 day ago | Updated 12 hours ago