Junior Validation Analyst Jobs

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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. 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

Computer Systems Validation engineer

Abbott Laboratories

Green Oaks, Illinois, 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. Abbott is a global healthcare leader, creating breakthrough science to improve people's health. We're always looking towards the future, anticipating

Computer Systems Validation engineer

Abbott Laboratories

Green Oaks, Illinois, 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. Abbott is a global healthcare leader, creating breakthrough science to improve people's health. We're always looking towards the future, anticipating

Computer Systems Validation engineer

Abbott Laboratories

Green Oaks, Illinois, 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. Abbott is a global healthcare leader, creating breakthrough science to improve people's health. We're always looking towards the future, anticipating

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

Senior Engineer Computerized System Validation

Takeda pharmaceutical

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

System Validation Engineer

SUPERMICRO COMPUTER INC

San Jose, California, USA

Full-time

Job Req ID: 26943 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

Sr. Instrument Verification and Validation Engineer

Katalyst Healthcares and Lifesciences

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

Validation Manager(Hybrid) Location:Raleigh, North Carolina

Stellent IT LLC

Raleigh, North Carolina, USA

Third Party, Contract

Validation Manager(Hybrid) Location:Raleigh, North Carolina Interview:Phone+Skype The Validation Manager, R&D IT is responsible for implementing a computer software assurance strategy for the R&D IT department. This includes reviewing and revising the existing processes and procedures, implementing an ALM tool and ensuring its successful adoption within R&D, and developing validation templates. A successful candidate will have recent CSA experience, an understanding of the regulatory landscap

Validation Support Engineer

Katalyst Healthcares and Lifesciences

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

CSV Engineer (Computer System Validation)

Katalyst Healthcares and Lifesciences

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

Sr. Validation Engineer (CSV)

Katalyst Healthcares and Lifesciences

California, USA

Full-time

Responsibilities: Create and execute Computer System Validation (CSV) deliverables (Validation Plans, Protocols, Reports, Trace Matrices, SOPs). Collaborate with Business Users, System Owners, IT teams, and Analysts to define validation requirements. Provide leadership and training in validation activities. Generate IQ/OQ/PQ protocols using Good Documentation Practices (GDP). Ensure compliance with quality system elements for computer systems/software testing. Perform gap assessments and remedia

Verification and Validation Engineer

Booz Allen Hamilton

Clearfield, Utah, USA

Full-time

Job Number: R0221685 Verification and Validation Engineer The Opportunity: Are you looking for an opportunity to combine your technical skills with big picture thinking to make an impact in national security? You understand your customer's environment and how to develop the right systems for their mission. Your ability to translate real-world needs into technical specifications makes you an integral part of delivering a customer focused engineering solution. When a user tries new sof tware, they

Validation Engineer

Katalyst Healthcares and Lifesciences

Rockford, Illinois, USA

Full-time

Responsibilities: Perform validation activities to ensure compliance with government and customer requirements. Prepare and execute validation protocols (IOQ, OQ/PQ) and related documentation for new customer/product/system launches. Maintain existing validated processes, coordinating internal and customer approvals as needed. Ensure validation documentation is complete, accurate, and properly closed, including organizing and coordinating multiple approvals. Assist in the change control pro

Engineer III, Validation

Thermo Fisher Scientific

Remote or Fair Lawn, New Jersey, USA

Full-time

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description When you're part of Thermo Fisher Scientific, you'll do meaningful work, and join a team that values performance, quality and innovation. As part of a successful, growing global organization you will be encouraged to perform at your best. With revenues of more than $40 billion and the largest investment in R&D in the industry, we give our people the resources and chances to create significant contributions to the

Sr. CSV Validation Engineer

Katalyst Healthcares and Lifesciences

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

Sr. CSV Validation Engineer

Katalyst Healthcares and Lifesciences

New Brunswick, New Jersey, USA

Full-time

Responsibilities: 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 establishing standard quality and validation pract

Principal Verification and Validation Engineer

BAE Systems

Potomac, Maryland, USA

Full-time

Job Description BAE Systems is seeking a full-time Principal Verification and Validation Engineer to support our work as a prime contractor on a high-profile U.S. Navy weapon system. The candidate will help guide and determine the verification approach for our Systems Engineering team as it incorporates Model Based Systems Engineering (MBSE) tools and methodologies to support the UK TRIDENT Submarine Strategic Weapon System (SWS) program. The ideal candidate would be self-motivated, good at pla

Validation Engineer

Katalyst Healthcares and Lifesciences

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

Principal Validation Engineer

Johnson & Johnson

Danvers, Massachusetts, USA

Full-time

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn m