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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 47 days ago | Updated 4 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 47 days ago | Updated 4 hours ago

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
Posted 47 days ago | Updated 4 hours ago

System Engineer

Cornerstone Defense

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Annapolis, Maryland, USA

Full-time

Location: Annapolis Junction Type: Contract Job #3719 Title: System Engineer Location: Annapolis Junction, MD Compensation Range: $150 -$170K *Clearance: *Active TS/SCI w/ Polygraph needed to apply * Company Overview: Cornerstone Defense is the Employer of Choice within the Intelligence, Defense, and Space communities of the U.S. Government. Realizing early on that our most prized assets are our employees, we continually focus our attention on improving the overall work/life experience they
Posted 4 days ago | Updated 4 hours ago

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
Posted 47 days ago | Updated 4 hours ago

Software Quality Engineer

Flextronics

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Austin, Texas, USA

Full-time

Job Posting Start Date 06-11-2025 Job Posting End Date 08-11-2025 Flex is the diversified manufacturing partner of choice that helps market-leading brands design, build and deliver innovative products that improve the world. A career at Flex offers the opportunity to make a difference and invest in your growth in a respectful, inclusive, and collaborative environment. If you are excited about a role but don't meet every bullet point, we encourage you to apply and join us to create the extraord
Posted 8 days ago | Updated 4 hours ago

SIT Lead / UAT & Integration Lead

SBS Creatix, LLC

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Remote

Contract

Responsibilities: To organize and drive the test prep and execution efforts for SIT and UAT, maintaining structure and consistency (to include the EDI team, all boundary apps, external trading partner testing.) To ensure proper test scenarios are captured / to ensure quality SIT and UAT testing (to include the EDI team, all boundary apps, external trading partner testing.) To facilitate collaboration among the teams to create test cases and plan for testing. (to include the EDI team, all boundar
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Posted 6 days ago

Software Engineering Advisors- Hybrid

Cigna

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Remote or Denver, Colorado, USA

Full-time

The job profile for this position is Software Engineering Advisor, which is a Band 4 Contributor Career Track Role with Cigna-Evernorth Services Inc. Responsiblities- Develop, maintain, and support applications, with strong emphasis on analysis of business requirements and written communication of technical design; Provide expert professional leadership on complex Software Engineering assignments and projects, and advise functional leaders; Provide comprehensive consultation to business unit an
Posted 24 days ago | Updated 4 hours ago

Information Assurance Engineer

General Dynamics

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Pittsburgh, Pennsylvania, USA

Full-time

Basic Qualifications Requires a Bachelor's degree in Engineering, or a related Science or Mathematics field. Also requires 5+ years of job-related experience, or a Master's degree plus 3 years of job-related experience. CLEARANCE REQUIREMENTS: Department of Defense TS/SCI security clearance is required at time of hire. Applicants selected will be subject to a U.S. Government security investigation and must meet eligibility requirements for access to classified information. Due to the nature of
Posted 13 days ago | Updated 4 hours ago

Advanced Information Assurance Engineer

General Dynamics

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Pittsburgh, Pennsylvania, USA

Full-time

Basic Qualifications Requires a Bachelor's degree in Engineering, or a related Science or Mathematics field. Also requires 5+ years of job-related experience, or a Master's degree plus 3 years of job-related experience. CLEARANCE REQUIREMENTS: Ability to obtain a Department of Defense Secret security clearance is required at time of hire. Applicants selected will be subject to a U.S. Government security investigation and must meet eligibility requirements for access to classified information.
Posted 13 days ago | Updated 4 hours ago

Senior Information Assurance Engineer

General Dynamics

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Colorado Springs, Colorado, USA

Full-time

Basic Qualifications Requires a Bachelor's degree in Engineering, or a related Science or Mathematics field. Also requires 8+ years of job-related experience, or a Master's degree plus 6 years of job-related experience. CLEARANCE REQUIREMENTS: Department of Defense TS/SCI security clearance is required at time of hire. Applicants selected will be subject to a U.S. Government security investigation and must meet eligibility requirements for access to classified information. Due to the nature of
Posted 27 days ago | Updated 4 hours ago

Systems Engineer 3 - Airframe Integration

Judge Group, Inc.

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Edmundson, Missouri, USA

Full-time

Location: Edmundson, MO Salary: Negotiable Description: Our client is currently seeking a Systems Engineer 3 - Airframe Integration Job Title: Airframe Integration & Verification (I&V) Engineer Location: St. Louis, MO Duration: 12+ Months Job Overview: We are seeking a motivated and skilled Airframe Integration & Verification Engineer to join our Systems Engineering, Integration, and Test (SEIT) team on the T-7 platform. This role plays a crucial part in ensuring airframe systems meet perf
Posted 45 days ago | Updated 1 hour ago

Computer System Validation Analyst - R Studio & Clinical Systems

Katalyst Healthcares and Lifesciences

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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 47 days ago | Updated 4 hours ago

IV&V Engineer

Westinghouse Electric Company LLC

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Warrendale, Oregon, USA

Full-time

Are you interested in being part of an innovative team that supports Westinghouse's mission to provide clean energy solutions? At Westinghouse, we recognize that our employees are our most valuable asset and we seek to identify, attract and recruit the most qualified talent while recognizing and encouraging the value of diversity in the global workplace. About the role: As an IV&V Engineer you will perform Independent Verification and Validation (IV&V) activities in support of safety system pr
Posted 35 days ago | Updated 4 hours ago

Software/Hardware Compliance Engineer

CDM Technology

•

Carlsbad, California, USA

Full-time

Job DescriptionWe are seeking an experienced Quality Engineer to manage creation of quality deliverables on a diagnostic instrument design project which includes software development and IEC 62304 compliance. This role ensures the integration of quality into both hardware and software design processes, maintaining compliance with regulatory standards such as ISO 13485, FDA 21 CFR Part 820, and IEC 62304. The successful candidate will work cross-functionally to ensure the diagnostic system meets
Posted 12 days ago | Updated 14 hours ago

Controls Systems Engineer IV (Electronics)

Rheem Manufacturing Company

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Lewisville, Texas, USA

Full-time

Job Description The Controls Systems Engineer IV is responsible for planning, implementing/executing, and documenting system engineering activities for Rheem electronic controls. This position will serve our Air Division located in Lewisville, TX (Hybrid). Responsibilities Active engagement with software, hardware, test, and product development teams over the entire product life cycle to ensure that system engineering work products are planned, documented, and completed.Document / Define / Updat
Posted 14 days ago | Updated 1 hour ago

Senior Information Systems Security Officer

Realm One

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Annapolis, Maryland, USA

Full-time

We're searching for talented individuals who provide intelligence, engineering, and mission management expertise for the Government.This program will maximize the effectiveness and efficiency of our country's most important missions both at home and abroad. If you are ready to support a high-performing team that truly makes a difference, thencome join us! Job Description: The Information System Security Officer will provide vital support for the implementation and maintenance of our information
Posted 47 days ago | Updated 4 hours ago

Airframe Integration & Verification (I&V) Engineer

Boeing Company

•

Berkeley, Missouri, USA

Full-time

This posting is for a contract assignment and is not a full-time employment offer with Boeing. Candidates selected for roles will be employed as contract workers through a Boeing approved 3rd party for the duration of the specified project. Job Title: Airframe Integration & Verification (I&V) Engineer (Associate or Experienced) Job Description: Client is seeking a highly skilled Associate or Experienced Airframe Integration & Verification Engineer to join our team working on the T-7 platform t
Posted 42 days ago | Updated 4 hours ago

Lead Information Systems Cyber Engineer

The MITRE Corporation

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San Diego, California, USA

Full-time

Why choose between doing meaningful work and having a fulfilling life? At MITRE, you can have both. That's because MITRE people are committed to tackling our nation's toughest challenges-and we're committed to the long-term well-being of our employees. MITRE is different from most technology companies. We are a not-for-profit corporation chartered to work for the public interest, with no commercial conflicts to influence what we do. The R&D centers we operate for the government create lasting im
Posted 17 days ago | Updated 4 hours ago

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
Posted 22 days ago | Updated 4 hours ago