Validation & Compliance Engineer Jobs

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Validation Engineer

Katalyst Healthcares and Lifesciences

Maple Grove, Minnesota, USA

Full-time

Responsibilities: Define the development of comprehensive specifications (hardware and/or software) for equipment/software from basic functionality to complex systems such as PLC's, Visual Basic applications, databases, SCADA applications, and systems with FDA defined electronic records and electronic signatures. Provide project estimates independently. Review estimates for Engineer I's. Submit specification, protocol and report for approvals and documentation control vi Change Request. Develop

Analog Custom Silicon Validation Engineer

Apple, Inc.

No location provided

Full-time

In this dynamic role, you will be responsible for working on leading-edge technology nodes, testing custom analog and mixed signal designs for our world-class products. You will join a hardware characterization team that promotes engineering excellence, creativity, and innovation. Envision the possibilities that await you at Apple! Collaborate with our team to shape the future of exceptional devices, services, and customer experiences. Innovation thrives here, propelling groundbreaking ideas int

Sr. Computer system Validation Engineer

Katalyst Healthcares and Lifesciences

Saint Joseph, 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. Enga

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

Staff Engineer, SSD Validation

Micron Technology, Inc.

Longmont, Colorado, USA

Full-time

Our vision is to transform how the world uses information to enrich life for all. Micron Technology is a world leader in innovating memory and storage solutions that accelerate the transformation of information into intelligence, inspiring the world to learn, communicate and advance faster than ever. Department Intro: The Non-Volatile Engineering Group (NVEG), a division within the Technology and Products Group (TPG), is dedicated to advancing non-volatile memory technologies, such as NAND. Ou

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

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

Verification & Validation Engineer

Katalyst Healthcares and Lifesciences

Plymouth, Minnesota, USA

Full-time

Job description: As a member of the Vantive Acute Therapies Verification and Validation engineering team, you would be responsible for supporting product verification, validation, and compliance test activities on electrical and mechanical medical device components/systems. Your expertise will be applied to all levels of product development from component prototypes to final system design. This will include developing, executing, and validating test methods/creating associated documentation. Int

Test and Validation Engineer II

RTX Corporation

Forest, Mississippi, USA

Full-time

Date Posted: 2025-03-13 Country: United States of America Location: MS301: 19859 Highway 80, Forest 19859 Highway 80 CMC Forest, Forest, MS, 39074 USA Position Role Type: Onsite U.S. Citizen, U.S. Person, or Immigration Status Requirements: Security Clearance: DoD Clearance: Secret At Raytheon, the foundation of everything we do is rooted in our values and a higher calling - to help our nation and allies defend freedoms and deter aggression. We bring the strength of more than 100 years of expe

Senior Engineer, Test and Validation

RTX Corporation

Tucson, Arizona, USA

Full-time

Date Posted: 2025-04-17 Country: United States of America Location: AZ811: RMS AP Bldg 811 1151 East Hermans Road Building 811, Tucson, AZ, 85756 USA Position Role Type: Onsite U.S. Citizen, U.S. Person, or Immigration Status Requirements: Security Clearance: DoD Clearance: Secret At Raytheon, the foundation of everything we do is rooted in our values and a higher calling - to help our nation and allies defend freedoms and deter aggression. We bring the strength of more than 100 years of exper

Electrical Engineer, Test & Validation (Onsite)

RTX Corporation

Rockford, Illinois, USA

Full-time

Date Posted: 2024-12-10 Country: United States of America Location: A01: Rockford - Aerospace 4747 Harrison Avenue, Rockford, IL, 61125 USA Position Role Type: Onsite Collins Aerospace, a leader in Generator and Emergency Power Test Equipment, is seeking an innovative and skilled Electrical Engineer to join our team. In this role, you will be responsible for developing cutting-edge test equipment and setups for the development and production of aircraft power generation components. Our Test Equ

Senior Validation Engineer

Katalyst Healthcares and Lifesciences

Marlborough, Massachusetts, USA

Full-time

Responsibilities: Derive test requirements from the design specifications, define test plan and methodology, estimate effort and resources plan to cover design verification and validation campaign. Establish acceptance criteria, sampling, assess through modeling or qualitative/quantitative testing, evaluate the performance according to URS, SRS (design inputs and outputs). Write test protocol, setup design of experiments, execute tests, analyse results and document reports for design verificati

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

Validation Engineer

Katalyst Healthcares and Lifesciences

Summit, New Jersey, USA

Full-time

Position Overview: The CSV Engineer supports the successful implementation of manufacturing and laboratory equipment and computerized systems at multi-use sites through interaction with internal customers and external service providers. The incumbent in this role, contributes to the completion of milestones associated with equipment qualification and systems validation. With minimum supervision and given general instructions, this individual carries out routine tasks, functions, and uses basi

Validation Engineer

Katalyst Healthcares and Lifesciences

Philadelphia, Pennsylvania, USA

Full-time

Job Summary The Validation Engineer is responsible for executing equipment and system validation activities within a regulated biopharmaceutical environment. This role involves implementing validation protocols, documenting results, and ensuring compliance with regulatory requirements. The position is based in West Philadelphia, Pennsylvania with a hybrid work arrangement. Responsibilities: Proficiency in Kaye AVS validation software. Experience with Valpro validation management systems. Compet

Sr Process Validation Engineer

Katalyst Healthcares and Lifesciences

Grand Rapids, Michigan, USA

Full-time

Roles & Responsibilities: Lead process validation projects of broad scope. Collaborate with clients, Validation, and cross-functional team members to coordinate projects, resolve issues, and meet aggressive timelines. Represent Validation in customer interactions and communicate customer requirements to the broader Validation team as needed. Oversee execution of process validation (PPQ) protocols on the production floor on varying shifts as needed to ensure that protocol requirements are satisfi

Validation Engineer

Katalyst Healthcares and Lifesciences

Waltham, Massachusetts, USA

Full-time

Responsibilities: Independently perform validation activities including installation qualification, operational qualification, performance qualification for Base Camp projects related to facility, utilities, equipment and instrument. Generate protocols for tests, verification, and qualification for GxP assets, as well as reports to document execution. Ensure deliverables meet the overall facility milestones. Perform and support periodic assessment review and revalidation activities. Ensure deliv

Senior Validation Engineer

Katalyst Healthcares and Lifesciences

Pomona, California, USA

Full-time

Roles & Responsibilities: 6 to 8 years of Non-Product Software Validation engineer with Manufacturing background (Medical devices or Diagnostics). Non-Product software validation for Manufacturing Equipment's as per Regulatory standards (FDA, ISO requirements). Prepare, review functional requirements, design and testing documents. Prepare, review of SLC deliverables (Validation plan, change requests, User requirements specification, Functional requirement specification, function risk assessment,

Senior Validation Engineer

Katalyst Healthcares and Lifesciences

Pomona, California, USA

Full-time

Responsibilities and requirements: 6 to 8 years of Non-Product Software Validation engineer with Manufacturing background (Medical devices or Diagnostics). Non-Product software validation for Manufacturing Equipment's as per Regulatory standards (FDA, ISO requirements). Prepare, review functional requirements, design and testing documents. Prepare, review of SLC deliverables (Validation plan, change requests, User requirements specification, Functional requirement specification, function risk a

Validation Engineer

Katalyst Healthcares and Lifesciences

Springfield, Illinois, USA

Full-time

Job summary: Seeking a Facilities Validation Specialist who will be responsible for working across two state-of-the-art medical device facilities. They will have a long-term contract position with significant project ownership an opportunity to work with advanced cleanroom environments and warehouse facilities. Responsibilities: Lead facility commissioning activities across multiple sites. Conduct temperature and humidity mapping studies. Perform cleanroom validation for Class 6, 7, and 8 envi