Computer system validation Consultant Jobs

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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

Computer System Validation (CSV) Engineer

Katalyst Healthcares and Lifesciences

Remote or Massachusetts, USA

Full-time

Responsibilities: Lead and execute CSV activities across GxP-regulated systems (LIMS, MES, ERP, etc. uthor 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 degree

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.

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

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

IT CSV Manager

4A IT Services LLC

Durham, North Carolina, USA

Contract, Third Party

We are seeking an experienced and highly motivated CSV Implementation Lead to drive the successful deployment and integration of enterprise systems including Dynamics 365, LIMS, POMS, MES, and other automation and data management platforms at a major life sciences/biotech site in the Raleigh, NC area. This is a 100% onsite role with a strong emphasis on leadership, mentoring, and capability-building of internal teams, reporting directly to the CSV/QA Manager. Required Skills & Qualifications: Mi

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

System Validation Engineer

Katalyst Healthcares and Lifesciences

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

Computer Vision- Data Scientist Consultant

Enexus Global

California, USA

Contract, Third Party

Role - Computer Vision- Data Scientist Consultant Location - Remote Exp - 12+ Years Tax Term- C2C, w2 Department Overview The Data Science & Artificial Intelligence Department consists of a "Delivery" team that develop data science and machine learning solutions and a "Center of Excellence" team that supports other practitioners in an enterprise-wide Hub & Spoke analytics adoption model. As a Delivery team, this Department uses industry leading data science and change management practices to d

System Validation Engineer

SUPERMICRO COMPUTER INC

San Jose, California, USA

Full-time

Job Req ID: 26644 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

Senior System Validation Engineer

Marvell Semiconductor Inc.

Santa Clara, California, USA

Full-time

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

Senior System Validation Engineer

NVIDIA Corporation

Santa Clara, California, USA

Full-time

Our technology has no boundaries! Nvidia is building the world's most groundbreaking and state of the art compute platforms for the world to use. It's because of our work that scientists, researchers and engineers can advance their ideas. At its core, our visual computing technology not only enables an amazing computing experience, but it is also energy efficient! We pioneered a supercharged form of computing loved by the most demanding computer users in the world - scientists, designers, artist

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

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

IT Consultant, SAFE-T System Telehealth

Penn State

State College, Pennsylvania, USA

Full-time

APPLICATION INSTRUCTIONS: CURRENT PENN STATE EMPLOYEE (faculty, staff, technical service, or student), please login to Workday to complete the internal application process. Please do not apply here, apply internally through Workday.CURRENT PENN STATE STUDENT (not employed previously at the university) and seeking employment with Penn State, please login to Workday to complete the student application process. Please do not apply here, apply internally through Workday.If you are NOT a current empl

Lead ACI Money Transfer System (MTS) Consultant--Charlotte, NC(Onsite)

HUMAC INC.

Charlotte, North Carolina, USA

Contract

Hello Friends, I Hope you are doing well. This is Surya from Humac Inc., Please check the following job description, and if you are interested, or know someone who might be interested, please share your updated resume to reach you. Role: Lead ACI Money Transfer System (MTS) Consultant Location:Charlotte, NC(Onsite) Job Details: Position Overview: We are looking for a Lead Consultant having 12 plus years of deep expertise in ACI Money Transfer System (MTS) and Universal Payment Framework (UPF) to

SAP LMS (Learning Management System) Consultant

Nexxora Inc.

Remote

Third Party, Contract

SAP LMS (Learning Management System) Consultant REMOTE LONGTERM Job Summary: We are seeking an experienced SAP LMS (Learning Management System) Consultant to implement, configure, and support SAP SuccessFactors Learning solutions. The consultant will work closely with HR, L&D, and IT stakeholders to design, deliver, and optimize digital learning experiences that align with business and compliance needs. Key Responsibilities: Implement and configure SAP SuccessFactors Learning (LMS) module based

Oracle Cloud Payroll Functional Consultant

SolutionIT, Inc.

US

Full-time, Third Party, Contract

Solution IT Inc. is looking for a Oracle Cloud Payroll Functional Consultant for one of its clients - Remote Job Title - Oracle Cloud Payroll Functional Consultant Job Description: Summary: We are seeking an experienced Oracle Fusion Payroll Consultant with a strong background in Public Sector implementations to join a high-impact project for a government customer in Florida. The ideal candidate will be responsible for the design, configuration, and implementation of Oracle Fusion Payroll module

Senior Staff System Validation Engineer

Marvell Semiconductor Inc.

Santa Clara, California, USA

Full-time

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

M365 Dynamics Consultant

GDH

US

Third Party, Contract

Job Description: Our client is seeking a highly skilled M365 Dynamics Consultant to manage, support, and optimize their enterprise resource planning (ERP) system using Microsoft Dynamics 365. This role is crucial for ensuring the effective configuration, maintenance, and performance of the Dynamics 365 environment across various departments. The ideal candidate will be adept at monitoring system performance, troubleshooting issues, and ensuring system security and data integrity. Responsibilit