computer system validation consultant Jobs

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Computer System Validation (CSV) Engineer

Jobot

•

Scottsdale, Arizona, USA

Full-time

Computer System Validation (CSV) Engineer with strong knowledge of FDA and cGMP regulations and documentation practices and 21 CFR Part 11. needed! (**Full relocation provided**) This Jobot Job is hosted by: Ryan Sullivan Are you a fit? Easy Apply now by clicking the "Apply Now" button and sending us your resume. Salary: $130,000 - $145,000 per year A bit about us: We are a fast-growing, Medical Device Manufacturer in Scottsdale, AZ, passionate about improving the lives of patients suffering
Posted 2 days ago | Updated 4 hours ago

Computer System Validation CSV Engineer

VetForce Solutions

•

Raritan, New Jersey, USA

Contract, Third Party

Role - Computer System Validation CSV Engineer Location - Raritan, NJ(Hybrid) Job Details: 7-10 years experience in Computer System Validation SAP ECC/S4, SolMan/ChaRM Change Control process Experienced in computer systems validation, GXP regulatory knowledge and good documentation methods and CSA approaches and risk-based validation. Knowledge in utilizing SDLC tools such as JIRA, qTest, X-ray, test automation tools and methods, Proficient knowledge on CFR Part 11 regulations and Quality Manag
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Posted 1 day ago

Computer System Validation Engineer

Katalyst Healthcares and Lifesciences

•

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 8 days ago | Updated 8 hours ago

Computer System Validation Engineer

Katalyst Healthcares and Lifesciences

•

Scottsdale, Arizona, USA

Full-time

Responsibilities: Execute and lead the validation of computer systems, ensuring compliance with 21 CFR Part 11, FDA regulations, and cGMP regulations. Develop, review, and approve validation documents, including validation plans, test scripts, and final reports. Coordinate and conduct validation activities in accordance with project timelines and business objectives. Implement and manage document control processes and systems. Evaluate and recommend improvements to existing systems and processe
Posted 8 days ago | Updated 8 hours ago

Computer System Validation Engineer

Katalyst Healthcares and Lifesciences

•

Cincinnati, Ohio, USA

Full-time

Responsibilities: Develop Project Plans for the qualification of the Drug Substance Manufacturing (DSM), Drug Product (DP). Finished Goods Manufacturing (FGM) Manufacturing, and IT Computerized Systems. Assist in the generation and development of documents, processes, and procedures of the Computer Systems Validation (CSV) program. Generate and review Manufacturing and IT Computerized Systems lifecycle documentation including risk and impact assessments, user requirement specifications, function
Posted 8 days ago | Updated 8 hours ago

Computer System Validation Engineer

Katalyst Healthcares and Lifesciences

•

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 8 days ago | Updated 8 hours ago

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
Posted 8 days ago | Updated 8 hours ago

Corporate Automation Computer System Validation Engineer - API Drug Substance

Eli Lilly and Company

•

Indianapolis, Indiana, USA

Full-time

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
Posted 10 days ago | Updated 8 hours ago

Computer System Validation Analyst - R Studio & Clinical Systems

Katalyst Healthcares and Lifesciences

•

Remote or New Jersey, USA

Full-time

Responsibilities: Lead validation planning, risk assessment, and execution for R Studio, GitLab, and Medidata Rave EDC. Develop and execute validation documentation including: Validation Plans (VP.). User Requirements Specifications (URS.). Risk Assessments (RA.). Functional and Design Specifications. Traceability Matrix (RTM.). Test Protocols (IQ/OQ/PQ or CSA-based scripts.). Validation Summary Reports (VSR.). Collaborate with cross-functional stakeholders including Clinical Data Mana
Posted 8 days ago | Updated 8 hours ago

CSV LEAD CONSULTANT

Sharpedge Solutions

•

King of Prussia, Pennsylvania, USA

Full-time

10+ years Experience in Validating systems and Experienced in CSV activities in GxP related applications like SAP Systems, Product Serialization systems, MES systems Perform review for GxP systems to ensure compliance with regulatory requirements Working knowledge on end-to-end validation of GxP applications and is able to perform documentprocess Compliance Analysis Adept with Agile and Waterfall methodology-based software development Compliance and has prior experience in Computer System Valid
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Posted 17 hours ago

Benchling Technical Support Specialist (GxP / CSV Experience Preferred)

Infinite Computer Solutions (ICS)

•

Remote

Third Party, Contract

Job Summary: We are seeking a skilled and proactive Technical Support Specialist with hands-on experience supporting Benchling, a leading cloud-based platform for life sciences R&D. The ideal candidate will have a strong background in providing technical application support within a regulated GxP environment, and exposure to Computer System Validation (CSV) is highly desirable. The role requires close collaboration with the client s IT and Quality teams to ensure consistent and compliant system
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Posted 21 days ago

System Validation Engineer

SUPERMICRO COMPUTER INC

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San Jose, California, USA

Full-time

Job Req ID: 26645 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 2 days ago | Updated 8 hours ago

Specialist Quality Management

Yoh - A Day & Zimmerman Company

•

Addison, Texas, USA

Contract

Are you a Quality Engineer with a passion for ensuring product integrity and regulatory compliance in a manufacturing environment? We re looking for a hands-on quality professional to lead root cause investigations, support validation efforts, and drive continuous improvement across our quality systems all within a highly regulated GMP setting. Must be local to the Dallas-Fort Worth area onsite required W2 only no C2C or third-party submissions accepted This is not a software QA position this ro
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Posted 8 days ago | Updated 5 hours ago

Software Validation Quality Consultant | Contract, W2

Alpha Business Solutions LLC

•

Nutley, New Jersey, USA

Contract

Our direct client a large pharmaceutical company is seeking to hire a Software Validation Quality Consultant for 6 months plus contract to work hybrid from their Nutley, NJ Job Title: Software Validation Quality Consultant Duration: 6 months plus Location: Nutley, NJ | Hybrid - must be a local candidate willing to come on site at least 2 days a week, with one of them being Wednesday (more, if needed). Looking for someone who has done Validation in the clinical space. Google Cloud Platform and
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Posted 15 days ago | Updated 2 hours ago

Embedded Software Engineer, Vehicle Computer Hardware System Validation

Tesla Motors

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Palo Alto, California, USA

Full-time

Tesla's Vehicle Computer Hardware System Validation team is expanding! We are seeking a skilled Embedded Software Engineer to lead the development of BIOS for new product bring-up, integrate firmware packages for contract manufacturers, and maintain testing firmware. You will play a pivotal role in driving projects forward at an accelerated pace by uniting contributions from cross-functional engineering and manufacturing teams into robust, scalable solutions. This position is integral to deliver
Posted 60+ days ago | Updated 6 days ago

Code Data Validation Consultant (Machine Learning & Data Processing)

U.S. Tech Solutions Inc.

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San Jose, California, USA

Contract

Job Description: Join our team to enable cutting-edge AI/ML innovation by building robust data pipelines and automation tools.You ll work closely with human data operators and generative AI teams to process, analyze, and optimize high-quality datasets for training machine learning models.Your work will directly impact the efficiency and performance of AI systems, from automating data quality checks to designing infrastructure that scales with evolving model requirements.This role is ideal for a
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Posted 28 days ago

Software Engineer: SoC System Stress Validation

Apple, Inc.

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No location provided

Full-time

Apple is where individual imaginations gather together, committing to the values that lead to great work. Every new product we build, service we create, or Apple Store experience we deliver is the result of us making each other's ideas stronger. That happens because every one of us shares a belief that we can make something wonderful and share it with the world, changing lives for the better. It's the diversity of our people and their thinking that inspires the innovation that runs through every
Posted 5 days ago | Updated 7 hours ago

Sr. Systems Development Engineer, Antenna System Validation, Kuiper

Amazon Kuiper Manufacturing Enterprises LLC

•

Redmond, Washington, USA

Full-time

Project Kuiper is an initiative to increase global broadband access through a constellation of 3,236 satellites in low Earth orbit (LEO). Its mission is to bring fast, affordable broadband to unserved and underserved communities around the world. Project Kuiper will help close the digital divide by delivering fast, affordable broadband to a wide range of customers, including consumers, businesses, government agencies, and other organizations operating in places without reliable connectivity. Key
Posted 15 days ago | Updated 11 hours ago

Sr. Systems Development Engineer, Antenna System Validation, Kuiper

Amazon Kuiper Manufacturing Enterprises LLC

•

Redmond, Washington, USA

Full-time

Project Kuiper is an initiative to increase global broadband access through a constellation of 3,236 satellites in low Earth orbit (LEO). Its mission is to bring fast, affordable broadband to unserved and underserved communities around the world. Project Kuiper will help close the digital divide by delivering fast, affordable broadband to a wide range of customers, including consumers, businesses, government agencies, and other organizations operating in places without reliable connectivity. Key
Posted 15 days ago | Updated 11 hours ago

Independent Verification & Validation (IV&V) Consultant ** Largely Remote **

Amerit Consulting

•

Sacramento, California, USA

Contract

Overview: Our client, a state agency, seeks an accomplished Independent Verification & Validation (IV&V) Consultant. Location: Sacramento, CA 95814 (Largely remote with occasional on-site work) Duration: 24 months contract with 1 optional year (total possible term: 3 years) Description: Seeks an IV&V Consultant to provide independent oversight and validation services.The project aims to replace eight legacy systems supporting the oversight of 72,000+ licensed community care facilities.The
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Posted 4 days ago | Updated 13 hours ago