junior validation lead Jobs

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Independent Verification and Validation (IV&V) Analyst

Dia Software Solutions

•

Lansing, Michigan, USA

Third Party, Contract

Hi, Greetings from DIA SOFTWARE SOLUTIONS LLC! We reaching out about an exciting Direct client opportunity with one of our clients. Please review the requirements and let me know if you are interested in this position? Direct client Req:: Need Senior Technical Strategist MI, Hybrid PLEASE SEND THE RESUMES TO SKUMAR AT DIASOFTWARESOLUTIONS DOT COM ! Job Description: Independent Verification and Validation (IV&V) Analyst **Please Read** Investment Management Team is seeking a seasoned professional
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Posted 3 days ago | Updated 2 days ago

CSV Validation Engineer

Katalyst Healthcares and Lifesciences

•

Austin, Texas, USA

Full-time

Roles and Responsibilities: Strong writing, grammar, and editing abilities to create clear and concise documentation. bility to adapt writing style to various audiences (e.g., end users, technical teams, or regulatory bodies). Document Design and Formattingo Proficiency with documentation tools. Knowledge of design principles to create well-structured documents (manuals, user guides, SOPs, etc.). Version Controlo Familiarity with tools like Git, SVN, or SharePoint to manage document revisions a
Posted 60+ days ago | Updated 5 hours ago

Validation Support Engineer

Katalyst Healthcares and Lifesciences

•

Boston, Massachusetts, USA

Full-time

Job Description: We are seeking an experienced Validation Support Engineer to lead validation activities for Beckhoff Twin CAT PLC-controlled systems in a 24/7 GMP-regulated manufacturing environment. The role focuses on ensuring compliance with FDA regulations (21 CFR Part 11, 210, 211, 820), GAMP5 methodologies, and internal quality standards. Responsibilities: Develop/update Validation Plans (VP) and Master Validation Plans (MVP). Lead GxP risk assessments for system changes. Author and
Posted 44 days ago | Updated 5 hours ago

Validation Engineer

Katalyst Healthcares and Lifesciences

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Raynham, Massachusetts, USA

Full-time

Responsibilities: Ask candidates if they have validated equipment and what type of equipment they have validated. Mechanical/manufacturing experience. Writing and executing validation protocols. CSV is nice to have, but if the candidate has done that exclusively it will not work. Requirements: A minimum of a Bachelor's degree in Engineering is required. Minimum of 1-3 years' experience in medical device manufacturing, Bio/pharma is also good Develop and implement processes to support the
Posted 60+ days ago | Updated 5 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 3 days ago | Updated 5 hours ago

Computer System Validation Engineer

Katalyst Healthcares and Lifesciences

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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 60+ days ago | Updated 5 hours ago

Independent Verification and Validation (IV&V) Analyst @ Lansing, MI - Hybrid - Only Locals

KSN Technologies, Inc.

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Lansing, Michigan, USA

Contract

Independent Verification and Validation (IV&V) Analyst Lansing, MI - Hybrid - Only Locals One Year Contract This is a Hybrid Position - NO REMOTE Position available. Currently we are hiring candidates who are authorized to work on our W2. Candidate with previous state/govt client experience is preferred. Interview Process: Candidates submitted must be willing to come onsite (Lansing, MI) for interviews. Accepting local candidates within 2 hours of Lansing ONLY. Position will be hybrid, in offi
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Posted 3 days ago | Updated 2 days ago

Senior Silicon Validation & Prototyping Engineer

Experis

•

Morrisville, North Carolina, USA

Full-time

Our 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. Job Title: Senior Silicon Validation & Pro
Posted 12 days ago | Updated 13 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 14 days ago | Updated 5 hours ago

Validation Manager(Hybrid) Location:Raleigh, North Carolina

Stellent IT LLC

•

Raleigh, North Carolina, USA

Contract, Third Party

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
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Posted 4 days ago | Updated 1 day ago

Validation Support Engineer

Katalyst Healthcares and Lifesciences

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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
Posted 51 days ago | Updated 5 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 2 days ago | Updated 5 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 13 days ago | Updated 5 hours ago

CSV Engineer (Computer System Validation)

Katalyst Healthcares and Lifesciences

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Kansas City, Missouri, USA

Full-time

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 Manager. Engage
Posted 58 days ago | Updated 5 hours ago

System Validation Engineer

SUPERMICRO COMPUTER INC

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San Jose, California, USA

Full-time

Job Req ID: 26864 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 22 days ago | Updated 5 hours ago

Sr. Validation Engineer (CSV)

Katalyst Healthcares and Lifesciences

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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
Posted 60+ days ago | Updated 5 hours ago

Validation Engineer

Katalyst Healthcares and Lifesciences

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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
Posted 60+ days ago | Updated 5 hours ago

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
Posted 13 days ago | Updated 6 hours ago

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
Posted 15 days ago | Updated 13 hours ago

Engineer III, Validation

Thermo Fisher Scientific

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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
Posted 47 days ago | Updated 5 hours ago