validation engineer senior jobs

Warsaw, Indiana

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Today

Roles & Responsibilities: Develops and Executes Process Validation Strategies Creates plans, protocols (IQ, OQ, PQ), and risk assessments to ensure effective processes for medical devices and equipment. Ensures Regulatory Compliance Adheres to FDA (21 CFR 820), ISO 13485, and other relevant regulations, participating in audits and maintaining up-to-date knowledge. nalyses Data and Reports Findings Compiles and analyzes validation data, writes comprehensive reports, and identifies trends for proc

Full-time

Intern - Hardware Validation Engineer

Boise, Idaho

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Today

Our vision is to transform how the world uses information to enrich life for all. Micron Technology is a world leader in innovating memory and storage solutions that accelerate the transformation of information into intelligence, inspiring the world to learn, communicate and advance faster than ever. Department Introduction Micron Technology's DIMM Module Development Group is at the forefront of advancing memory technologies that power high-performance computing, AI, and next-generation data c

Full-time

Data Validation QA Engineer - Remote (Must have: QA, K-anonymity validation techniques, SQL, data comparison and profiling, defect tracking tools) 12 months contract - direct client...

Remote

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4d ago

Must have: QA and data validation, strong understanding of K-anonymity validation techniques, SQL for data comparison and profiling, defect tracking tools & good communication skills Job Summary: We are seeking an experienced QA Engineer Anonymization Validator to ensure the accuracy, quality, and compliance of data masking and anonymization solutions. The role focuses on validating anonymized datasets against privacy standards and regulatory requirements while supporting UAT and compliance sign

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Contract

Depends on Experience

Jr Embedded Systems Validation

Mossville, Illinois

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5d ago

Must have 3+ yrs of embedded systems validation experience Must have experience designing and conducting test cases for complex electronic systems Must have Linux OS, wire and wireless networking experience Must have HIL-based system testing, preferably dSPACE Must have Matlab/Simulink experience Education: Bachelors in Electrical or Electronics, Mechanical, Computer Engineering , or Computer Science Qualifications: 3-5 years of embedded systems validation experience Top Skills: Experience des

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Contract

$30 - $35

Kneat System Developer (Technical & Validation Focus)

Remote or Parsippany-Troy Hills, New Jersey

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2d ago

Job Title: Kneat System Developer (Technical & Validation Focus) Location Remote/WFH Duration: 6 months+ contract Note: Need strong Kneat Development / Configuration and not a user of Kneat. Overview of the Project: You will be configuring Kneat workflows and interacting with business stakeholders. Key Responsibilities: Develop, configure, and maintain Kneat GxP Validation software. Create and manage disciplines and templates. Ensure system validation and compliance with GxP, 21 CFR Part 11,

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Contract, Third Party

Computer System Validation Analyst

Foster City, California

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Today

Summary : Plan, lead, and execute the validation efforts for SCADA, Rockwell Factory Talk, PLC's and Ignition Create/write validation documentation (VP/URS/FS/DS/Trace Matrix/Risk Assessment/IQ/OQ/PQ, etc.) for process control systems. Author documents related to GxP Systems Draft Requirements and computer systems validation documents using GAMP 5 Execute test protocols for the software validation. Initiate and execute change management for existing qualified systems. Develop change management

Full-time

Clinical Imaging & Machine Learning (ML) Validation Specialist

Remote

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5d ago

Job Title: Clinical Imaging & Machine Learning (ML) Validation Specialist Location: Remote Duration: Long Term Experience: 8 Years Job Summary The Clinical Imaging & ML Validation Specialist is responsible for validating, evaluating, and clinically contextualizing machine learning models applied to medical imaging. This role bridges clinical imaging expertise (radiology, pathology, cardiology, etc.) with data science and regulatory rigor to ensure ML models are accurate, reliable, unbiased, and

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Contract

Depends on Experience

GXP Systems Validation Lead

Oregon City, California

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12d ago

GXP Systems Validation Lead Oregon City, California 12+ Months Job Description: Configuration Specialists and Tester Team (Leads) Determines validation approach, identifies deliverables needed or impacted by a project enhancement or change for GXP computerized systems and Infrastructure Responsible for the review of software documentation according to CSV corporateSOP39s, and regulatory guidance Provide estimates and forecast validation activities for a project Author validation plans reports,

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Third Party, Contract

Depends on Experience

Software Validation Engineer Intern - Master's Degree

Santa Clara, California

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Today

About Marvell Marvell's semiconductor solutions are the essential building blocks of the data infrastructure that connects our world. Across enterprise, cloud and AI, automotive, and carrier architectures, our innovative technology is enabling new possibilities. At Marvell, you can affect the arc of individual lives, lift the trajectory of entire industries, and fuel the transformative potential of tomorrow. For those looking to make their mark on purposeful and enduring innovation, above and be

Full-time

USD 25.00 - 50.00 per hour

DATA ANALYST (VALIDATION) | COLUMBUS, OH (REMOTE)

Remote or Columbus, Ohio

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2d ago

JOB TITLE: DATA ANALYST (VALIDATION) JOB DURATION: 1 YEAR JOB LOCATION: COLUMBUS, OH (REMOTE) EXPERIENCE: 8+ YEARS VISA: , - 1099 Job Description The ideal candidate brings 8+ years of data quality engineering experience with a strong analytical mindset and the ability to investigate datasets holistically understanding how data relates to itself and to adjacent datasets, formulating the right questions, and designing targeted analyses to uncover issues or validate accuracy. They should be

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Contract

USD 50-57

Computer System Validation - CSV Engineer

Remote or New Jersey

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Today

Roles & Responsibilities: Minimum 8+ years of relevant experience; can work independently and guide/mentor Junior resources. Experience in the Pharmaceutical, biotechnology, or medical device industry with System Development Lifecyle in Computer System Validation Experience in FDA and/or Global regulated environment with good understanding of GxP standards and Risk based validation. Knowledge of FDA guidance's and industry standards (i.e., GAMP) Experience in writing and executing documen

Full-time

IT CSV & CQV Validation Lead

Boston, Massachusetts

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Today

Responsibilities: Documentation & Deliverables: Develop and author comprehensive validation and quality documentation, including protocols, reports, risk assessments, SOPs, and other project-related materials. Ensure all documentation complies with applicable regulatory standards such as FDA, EMA, GxP, and other relevant guidelines. Review and approve validation documents to confirm alignment with both project objectives and regulatory requirements. Project Management: Lead and oversee multiple

Full-time

2026 Summer Internship Program: Engineering Validation Intern - Operational Technology and Computerized Systems Validation

Brooklyn Park, Minnesota

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Today

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 At Takeda's Brooklyn Park, MN, Facility, we manufacture Entyvio and Adcetris - monoclonal antibody therapies that help patients live

Full-time

USD 21.00 - 46.00 per hour

AWS Infrastructure Qualification & Validation Specialist

Redwood City, California

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Today

Summary: We are seeking a skilled professional to lead and execute Infrastructure Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) documentation for AWS-hosted environments. This role is critical in ensuring our cloud infrastructure meets regulatory compliance standards (e.g., GxP, HIPAA, ISO 27001) through robust validation and documentation practices. Roles & Responsibilities: Develop and maintain IQ/OQ/PQ documentation for AWS infrastructure components. C

Full-time

AWS Infrastructure Qualification & Validation Specialist

California

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Today

Job Description (JD): For a role focused on Infrastructure Qualification and Validation Documentation for AWS-tailored for regulated environments like pharma, biotech, or any GxP-compliant organization. We are seeking a skilled professional to lead and execute Infrastructure Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) documentation for AWS-hosted environments. This role is critical in ensuring our cloud infrastructure meets regulatory compliance standar

Full-time

Clinical Imaging & ML Validation Specialist

Remote

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5d ago

REMOTE OPPORTUNITY Role Overview We are seeking a highly skilled professional with expertise in clinical imaging workflows and machine learning (ML) validation within the framework of Good Clinical Practices (Google Cloud Platform). The ideal candidate will bridge the gap between clinical imaging standards and advanced AI/ML technologies, ensuring compliance, accuracy, and reliability of algorithms used in life science.Key Responsibilities Understand and document end-to-end clinical imaging pro

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Part-time

Depends on Experience

SAP Validation Consultant

No location provided

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Today

Position: SAP Validation Consultant Location/ Travel Onsite Requirements 100% remote Responsibilities: Lead GxP validation efforts for the SAP S4 HANA system, ensuring compliance with industry regulations and standards Develop and execute validation plans, protocols, and reports to document compliance and system performance Collaborate with cross-functional teams to identify validation requirements and ensure alignment with business objectives Provide expert guidance and support during audi

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Full-time, Contract, Third Party

Manager, Computer System Validation

Petersburg, Virginia

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Today

About Civica: Critical shortages of essential generic injectable drugs are an ongoing crisis in U.S. healthcare and have reached an all-time high. Over 300 essential medications are currently reported to be in shortage, according to industry and FDA reports. Shortages put patients at risk and waste hospital resources. Civica is a market-based nonprofit solution created in 2018 by health systems and philanthropies for the express purpose of preventing and mitigating drug shortages. Today, near

Full-time

Advanced Measurements Technology - Section Leader (Product Validation - Test Measurements)

Evendale, Ohio

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Today

Job Description Summary The Advanced Measurements Technology section leader will lead a high-performing team to define the strategy and drive the execution for our core measurements technology platforms and products. You will be responsible for advancing measurements and sensing technologies to support next generation aerospace products and propulsion technologies. This role requires a unique blend of leadership skills, deep technical expertise, and a strong technical product management backgro

Full-time

Associate Director, Site Data Integrity and Computer System Validation Lead

Pleasant Prairie, Wisconsin

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Today

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined

Full-time

USD 111,000.00 - 178,200.00 per year

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validation engineer senior jobs