Medical Validation/Qualification Engineer Jobs

141 - 160 of 275 Jobs

Validation EngineerJob Title - Validation Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Princeton, New Jersey, USA

Full-time

Roles & Responsibilities: Develop and execute validation protocols for computer systems. Ensure compliance with regulatory requirements and industry standards. Create detailed validation documentation including plans, reports, and scripts. Conduct risk assessments and impact analyses related to computer systems. Coordinate and supervise testing activities. Collaborate with cross-functional teams to maintain and improve system validation processes. Monitor and report on validation project

Process Validation EngineerJob Title - Process Validation Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Albany, Georgia, USA

Full-time

Responsibilities: Spearhead qualification protocols for next-generation manufacturing processes. Drive manufacturing investigations and implement innovative solutions. Design validation strategies for new product launches and technology transfers. Lead comprehensive IQ/OQ/PQ validation activities across multiple projects. Create robust standard operating procedures for manufacturing excellence. Ensure continuous process verification for robust manufacturing operations. Coordinate cross-fu

Validation EngineerJob Title - Validation Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Oceanside, California, USA

Full-time

Responsibilities: Lead or support cleaning, equipment, utilities, sterilization and/or autoclave qualification due to equipment modifications for tech transfers, Make-Assess-Release (MAR) or routine re-qualification activities. Ensure the timely completion of Cleaning Monitoring as well as validation team assignments. Any deviations, anomalies or schedule impacting items are to be reported to site management. This position provides trained technical resources for the development and executio

Process Validation EngineerJob Title - Process Validation Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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St. Louis, Missouri, USA

Full-time

Responsibilities: Provide technical support and routine process monitoring for commercial products manufactured at CMOs. Provides person-in-plant observations of manufacturing operations at CMOs and communicates observations to the product team. Reviews manufacturing processes, deviations, and/or development and production data. Reviews manufacturing batch records, protocols, and control strategies. Provide technical support and data analysis for investigations and deviation resolution. Recommen

Validation EngineerJob Title - Validation Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Richmond, Virginia, USA

Full-time

Responsibilities: Develop and implement comprehensive validation plans for packaging lines, labelers, case packers, and low-speed pen assembly. Lead the validation of various systems, including SEA Vision Yudoo and AVI systems, ensuring compliance with industry standards and regulatory requirements. Prepare, execute, and document Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and Validation Summary Reports (VSR). Collaborate with cross-functional

Validation EngineerJob Title - Validation Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Richmond, Virginia, USA

Full-time

Sr Process Validation EngineerJob Title - Sr Process Validation Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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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 EngineerJob Title - Validation Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Thousand Oaks, California, USA

Full-time

Responsibilities: Plan and track implementation of commissioning & qualification actions/documentation versus project(s) timelines. Author/evaluate qualification/validation protocols including DQ, IQ, OQ, FT, PQ protocols and final reports for new or modified GMP utilities, facilities, and process equipment. Execute DQ, IQ, OQ, FT, PQ protocols, which involve protocol discrepancies, investigation, and corrective action activities for new or modified GMP utilities, facilities, and process equi

Validation EngineerJob Title - Validation Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Richmond, Virginia, USA

Full-time

Responsibilities: Ensure that all manufacturing equipment (e.g., mixers, conveyors, packaging lines) undergoes Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) to confirm that they function correctly and meet operational specifications. Validate manufacturing processes to ensure they are capable of consistently producing products that meet quality standards. This includes processes like blending, cutting, rolling, and packaging. Regularly revali

Process Validation EngineerJob Title - Process Validation Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Austin, Texas, USA

Full-time

Responsibilities: Author, review, and execute validation protocols (IQ, OQ, TMV, PQ) for process validation and re-validation activities in compliance with FDA/AAMI/ISO/EN guidelines/standards. Actively participate in all phases of process qualification. Evaluate projects, provide guidance and technical information, generate protocols, execute qualification activities, analyze data, and prepare reports. Lead all assigned qualification activities and make independent decisions related to thes

Validation EngineerJob Title - Validation Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Warsaw, Indiana, USA

Full-time

Responsibilities: Develops and Executes Cleaning Validation Strategies: Creates plans, protocols (IQ, OQ, PQ), and risk assessments to ensure effective cleaning processes for medical devices and equipment. Ensures Regulatory Compliance: Adheres to FDA (21 CFR 820), ISO 13485, and other relevant regulations, participating in audits and maintaining up-to-date knowledge. Analyzes Data and Reports Findings: Compiles and analyzes validation data, writes comprehensive reports, and identifies trends

Validation Engineer IIIJob Title - Validation Engineer III

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Plainsboro Township, New Jersey, USA

Full-time

Job Description: Qualified candidates must be experienced in one or more of the following areas of validation: Equipment Qualification Process Qualification The candidate must utilize problem solving techniques to resolve issues and conflict in order to meet the high level goals set forth by the organization. The candidate must be well organized and technically sound in understanding scientific rationale and justifying criterion from a quantitative standpoint. The candidate must be familiar with

Process Validation EngineerJob Title - Process Validation Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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East Windsor, New Jersey, USA

Full-time

Responsibilities: Previous experience as a validation engineer in an aseptic pharmaceutical fill/finish environment. Prior experience executing validation protocols on a pharmaceutical fill/finish line. Specific line components include. Lyophilizers. Depyrogenation tunnels. Autocalves. Previous experience with the project management requirements of validation project in a GMP environment. Requirements: Managing validation schedule. Communication of delays and changes to timelines. Coor

Validation EngineerJob Title - Validation Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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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

Validation EngineerJob Title - Validation Engineer

AdientOne LLCCompany Name - AdientOne LLC

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Texas, USA

Contract

Role: Validation Engineer Location: Austin TX 78735 | Hybrid Duration: 12+ months Notes: We are looking for an engineer with experience in power or performance attainment of features of CPU, GPU, or APUs. This person should thrive in a matrixed environment spanning multiple countries and time zones. Job Duties: In this role, this engineer will be part of a highly technical team that develops test plans, completes functional & electrical validation, & debugs issues for new processor silicon inte

Senior Software Engineer - Robotics Validation and BenchmarkingJob Title - Senior Software Engineer - Robotics Validation and Benchmarking

NVIDIA CorporationCompany Name - NVIDIA Corporation

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Santa Clara, California, USA

Full-time

NVIDIA is searching for a Senior Engineer to lead robotics benchmarking efforts across software-in-the-loop (SIL) and hardware-in-the-loop (HIL) systems for Physical AI applications. This is a unique opportunity to shape the future of intelligent machines by developing scalable, accurate, and high-fidelity benchmarking tools that drive innovation in autonomy, robotics, and AI at the edge. As part of our team, you'll work closely with world-class engineers, researchers, and product teams to evalu

Wireless Systems Validation Engineer - NFCJob Title - Wireless Systems Validation Engineer - NFC

Apple, Inc.Company Name - Apple, Inc.

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No location provided

Full-time

At Apple, we work every single day to craft products that enrich people's lives. Do you love working on challenges that no one has solved yet? Do you like changing the game? As a member of our dynamic group, you will have the unique and rewarding opportunity to shape upcoming products that will delight and inspire millions of Apple's customers every day. Apple's RF System Engineering team is looking for a passionate, self-motivated individual to work on integration of NFC technologies into Apple

Validation Engineer, Sterile & CleaningJob Title - Validation Engineer, Sterile & Cleaning

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Bedford, Massachusetts, USA

Full-time

Responsibilities: We are seeking an experienced Sterile & Cleaning Validation Engineer to support validation activities within a medical device manufacturing environment. The ideal candidate will have hands-on experience with sterile and cleaning validation processes, strong technical writing skills, and the ability to execute validation protocols independently. This role involves performing revalidation tasks for equipment and working closely with cross-functional teams. Develop and execute

Silicon Validation EngineerJob Title - Silicon Validation Engineer

Qualcomm TechnologiesCompany Name - Qualcomm Technologies

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San Diego, California, USA

Full-time

Company: Qualcomm Technologies, Inc. Job Area: Engineering Group, Engineering Group > GPU ASICS Engineering General Summary: We are looking for a motivated engineer with passion for problem solving to join our team and work on our world-class semiconductor chips. As a member of our Graphics Post-silicon team, you will be involved in all the phases of our silicon validation stage to ensure the successful commercialization of our GPU in the next generation chips. In this position, you will be

Validation EngineerJob Title - Validation Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Los Angeles, California, USA

Full-time

Responsibilities: Conceives, plans and executes manufacturing process validations plans and studies. Adhere to the Change Control and Design Control requirements. To create robust validation documents such as Master Validation Plans / Report, IQ, OQ, & PQ's. Being the lead on the writing and execution of IQ/OQ/PQ protocols. RCH/PCH - Routing in MAP Agile & follow up till release. Updating Control Plan (CP), Assembly Procedure (AP) & Traveler document (TD). Preparing protocol & executing Te