medical validation/qualification engineer Jobs

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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

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

Senior Engineer - Product Validation

Apptronik

Austin, Texas, USA

Full-time

Apptronik is building robots for the real world to improve human quality of life and to help solve the ever-increasing labor shortage problem. Our team has been building some of the most advanced robots on the planet for years, dating back to the DARPA Robotics Challenge. We apply our expertise across the full robotics stack to some of the most important and impactful problems our society faces, and expect our products and technology to change the world for the better. We value passion, creativi

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. Validation Engineer (CSV)

Katalyst Healthcares and Lifesciences

California, USA

Full-time

Responsibilities: Creates Computer System Validation (CSV) deliverables (Validation Plan, Requirements Specifications, Protocols, Summary Reports, Trace Matrices, SOPs, Risk assessments). Collaborates with Business Users, System Owner, Global IT teams and Business Analysts to define validation requirements and plans. Providing leadership, oversight, and training related to validation activities to multi-functional teams. Generate and execute validation protocols (IQ/OQ/PQ) using Good Documentati

Validation Engineer

Katalyst Healthcares and Lifesciences

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

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

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

Data Integrity QA Validation Engineer

Katalyst Healthcares and Lifesciences

Rensselaer, New York, USA

Full-time

Responsibilities: Participate on teams of internal resources in delivery of CSV projects. Author functional requirements specifications that are complete, accurate, and testable. Author system Risk Assessments, 21 CFR 11 Assessments, and Annex 11 Assessments. Author Validation Plans and Validation Reports. Author validation and verification testing protocols/scripts (i.e., IQ, OQ, PQ) and Trace Matrices. Experience in validation at least two of these computer system categories: automation contro

Embedded Software Validation Engineer, Optimus

Tesla Motors

Palo Alto, California, USA

Full-time

Optimus firmware team is growing, and we are looking to hire a Software Validation Engineer to take ownership of architecting, building and maintaining test infrastructure for joint controllers. This work will enable the team to ship software releases to our growing robot fleet with high confidence. We are looking for an experienced Validation Engineer to create validation infrastructure from scratch to continuously test safety critical code changes for joint controllers. In addition, this role

Quality Assurance Engineer - Process and Validation

Civica Rx

Petersburg, Virginia, USA

Full-time

About Civica Civica is a 501(c)(4) social welfare organization established in 2018 by health systems and philanthropies to reduce chronic generic drug shortages and related high prices in the United States. Civica is led by an experienced team of healthcare and pharmaceutical industry leaders. Today, more than 55 health systems have joined Civica. They represent over 1,500 hospitals and one-third of all U.S. hospital beds. Civica has also begun to supply the U.S. Department of Veteran's Affairs

Engineer III, Validation

Thermo Fisher Scientific

Remote or Waltham, Massachusetts, USA

Full-time

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description COMPANY: Thermo Fisher Scientific Inc. LOCATION: 168 Third Avenue, Waltham, MA 02451 TITLE: Engineer , Validation HOURS: Monday to Friday, 8:00 am to 5:00 pm DUTIES: Perform technical diagnosis of operational problems, repairs, and calibrations on a wide range of laboratory equipment to ensure that the equipment is operating to the customer's complete satisfaction and manufacture specifications; Perform techn

SWAT Root Cause Engineer Automotive ( Vehicle Systems Validation Engineer )

Aziro Technologies LLC

Auburn Hills, Michigan, USA

Full-time

Job Title: SWAT Root Cause Engineer Location: Auburn Hills, Michigan What you ll be doing: The SWAT Root Cause Engineer is responsible to lead electrical issue identification and resolution for all electrical features on a program line to ensure successful vehicle launch while working with various Engineering Support teams that include systems, wiring, design release and validation engineers, Program Management, and Manufacturing teams as required to support and launch vehicle programs. Responsi

Systems Validation Engineer

Apple, Inc.

No location provided

Full-time

Apple is where individual imaginations gather together, committing to the values that lead to great work. Every new product we build, service we create, or Apple Store experience we deliver is the result of us making each other's ideas stronger. That happens because every one of us shares a belief that we can make something wonderful and share it with the world, changing lives for the better. It's the diversity of our people and their thinking that inspires the innovation that runs through every

Diag Engineer/Hardware Validation Engineer

Satwic Inc

San Jose, California, USA

Third Party, Contract

Job Description Engineer will work Sunday to Thursday and or other engineer Tuesday to Saturday (one weekend day they have to work) Swing Shift - 3 to 11:30 PM Only (please check with candies before sharing resumes) Mandatory skills: Strong in Python, server side like PCIE, Networking, Electrical Engineering background. Key Responsibilities: Perform first-level hardware triage and troubleshooting for PCs and server platforms.Support hardware board bring-up, diagnostics, and test development, es

Aerospace Test & Validation Engineer

TechSpace Solutions Inc.

Middletown, Connecticut, USA

Contract

Job Title: Aerospace Test & Validation Engineer Location: Middletown, CT (Onsite) Duration: 12+ months In this role, you will be working alongside OEM customer teams performing engineering validation tasks supporting aircraft engine development, testing and certification. Responsibilities Coordinate engine test and/or assembly/tear-down actions between the technicians and IPT/Engineering groups.Communicate technical issues to IPT/Engineering groups and work with cross-functional teams to support

Senior SSD Validation Engineer

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. Act as the subject matter expert for validation on customer test requirements and results. Review and challenge current test plans, coverage, and testing activities to drive both increased effectiv

Sr. Software Validation and HIL Engineer, Power Electronics Functional Safety

Rivian

Torrance, California, USA

Full-time

About Rivian Rivian is on a mission to keep the world adventurous forever. This goes for the emissions-free Electric Adventure Vehicles we build, and the curious, courageous souls we seek to attract. As a company, we constantly challenge what's possible, never simply accepting what has always been done. We reframe old problems, seek new solutions and operate comfortably in areas that are unknown. Our backgrounds are diverse, but our team shares a love of the outdoors and a desire to protect it

Internship, Software Validation Engineer, Vehicle Firmware (Fall 2025)

Tesla Motors

Palo Alto, California, USA

Full-time

Consider before submitting an application: This position is expected to start around August or September 2025 and continue through the Fall term (ending approximately December 2025) or continuing into Winter/Spring 2026 if available and there is an opportunity to do so. We ask for a minimum of 12 weeks, full-time and on-site, for most internships. Our internship program is for students who are actively enrolled in an academic program. entry level candidates seeking employment after graduation a

Process Engineer I - API Cleaning Validation

Novo Nordisk Inc

Clayton, North Carolina, USA

Full-time

About the Department At Novo Nordisk, we are helping to improve the quality of life for millions of people worldwide. For more than 100 years, we have led the way in diabetes care. Being part of Novo Nordisk allows our employees to embark on life-changing careers, and the opportunity to help improve the quality of life for millions of people around the world. In NC, we operate three pharmaceutical manufacturing facilities that are responsible for fulfilling different steps in our injectable an