Validation Engineer III Jobs

181 - 200 of 280 Jobs

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

Process Validation EngineerJob Title - Process Validation Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Danvers, Massachusetts, USA

Full-time

Roles & Responsibilities: Process Validation (IQ/OQ/PQ). Product development experience. Process development. Process Layout, Modeling, and Documentation. Equipment and Tooling Development. Process Development and Characterization. Test Method Development and Validation. Developing / Updating MPIs. Supplier Development and Component Engineering. Manufacturing Engineering Support / Engineering Documentation. Update work instructions to match the practice on the floor to what's in the p

Validation EngineerJob Title - Validation Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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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

Process Validation EngineerJob Title - Process Validation Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Swiftwater, Pennsylvania, USA

Full-time

Roles & Responsibilities: Bachelor's degree in science or engineering (MS accepted, PhD is overqualified). Minimum 2+ years in Process Validation within the biotech/pharma industry. Writing and executing process validation documents. Strong Process Performance Qualification (PPQ) experience. Hands-on experience collecting process samples. Must have on-the-floor manufacturing experience. Familiarity with GMP best practices. Proficient in MS Office (Word, Excel, PowerPoint). Strong w

Validation EngineerJob Title - Validation Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Huntington, Texas, USA

Full-time

Roles & Responsibilities: M.S. in Engineering or Biomedical Engineering 1+ year of professional experience in a Medical Device Manufacturing Environment Lead, execute, document & manage the validation activities (IQ/OQ/PQ) necessary to support the introduction or revision of automated and semi-automated production equipment and processes for Ophtalmic medical devices Design, develop, validate and implement manufacturing processes to build opthalmic medical devices for cataract and vitroreti

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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Mossville, Illinois, USA

Full-time

Responsibilities: ssess and plan work to mitigate risk in NTI and NPI programs. Work with design leads to establish an initial first-pass test plan early in a program (pick list review to document leverage opportunity, VPD and potential test load). Participate in or Plan and Host Simulation and Test Collaboration Workshops (STCW) early in programs, pre-DFMEA to create high-level Validation Plan. Communicate progress in Gateway Reviews including System Readiness Summaries. Quality approval of FME

Validation EngineerJob Title - Validation Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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South Carolina, USA

Full-time

Responsibilities: Provide technical input to validation activities. Represent process validation during equipment installations. Support process validation Quality Systems. Identify opportunities for personal and professional development, continuous improvements, and help deploy best practices. Participate in regulatory agency inspections for Process Validation. Serve as one of the main points of contact in communication to customers whose equipment and processes are being validate. Responsible

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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Nashville, Tennessee, USA

Full-time

Responsibilities: Ensure all manufacturing equipment (e.g., mixers, conveyors, packaging lines) undergoes: These confirm proper functionality and adherence to operational specifications. Validate manufacturing processes (e.g., blending, cutting, rolling, and packaging) to ensure consistent production of high-quality products. Conduct revalidation of equipment and processes when changes occur, such as: ssess risks related to equipment, processes, and production areas that could impact product qua

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

Site Validation EngineerJob Title - Site Validation Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Holdrege, Nebraska, USA

Full-time

Responsibilities: Support the plant on assigned new and existing product initiatives with technical expertise and determine associated resource needs to accomplish project goals. Develop and maintain the Validation Master Plan and validation tracking schedule. Provide visibility related to all validation activities through tracking and reporting plant metrics. Support and influence change management within the plant: liaison between the core team, program managers, and Global quality. Conduct tr

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

Mid/Senior Level Validation Specialist/EngineerJob Title - Mid/Senior Level Validation Specialist/Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Marietta, Pennsylvania, USA

Full-time

Roles & Responsibilities: Prior experience with Aseptic Fill Finish Equipment or Lyophilizes is required. Strong technical writing skills, verbal, and written communication skills. Strong interpersonal skills (require interaction with client employees). Responsible for the development and execution of validation life cycle deliverables associated with this project. Minimum of Five (5) years of experience with commissioning and qualification including using ISPE C&Q guidelines. Knowledge of

GXP Validation EngineerJob Title - GXP Validation Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Boca Raton, Florida, USA

Full-time

Responsibilities: 12 years' Experience in Validating systems and Experienced in GxP related applications. Perform review for GxP systems to ensure compliance with regulatory requirements as per the customer SOPs. Expertise on end-to-end validation of GxP applications and is able to perform document/process Compliance Analysis Adept with Agile and Waterfall methodology. Requirement Specifications, Functional Specifications/ User Stories / Acceptance Criteria and ensures completeness of test scr

Validation Engineer NPIJob Title - Validation Engineer NPI

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Irving, Texas, USA

Full-time

Roles and responsibilities: NPI Validation, Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), pFMEA and dFMEA. 3+ years of experience & demonstrated proficiency in New Product Introduction, Windchill PLM & providing ongoing technical support is preferred. Under limited supervision, performs and documents moderately complex technical functions relating to test, quality control, Client-out, fabrication, modification, and assembly of mechanical

Senior Hardware Validation EngineerJob Title - Senior Hardware Validation Engineer

NVIDIA CorporationCompany Name - NVIDIA Corporation

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Santa Clara, California, USA

Full-time

NVIDIA has continuously reinvented itself over two decades. Our invention of the GPU in 1999 sparked the growth of the PC gaming market, redefined modern computer graphics, and revolutionized parallel computing. More recently, GPU deep learning ignited modern AI - the next era of computing. NVIDIA is a "learning machine" that constantly evolves by adapting to new opportunities that are hard to solve, that only we can tackle, and that matter to the world. This is our life's work, to amplify human

Software Engineer: Validation of Crypto and Security IPsJob Title - Software Engineer: Validation of Crypto and Security IPs

Apple, Inc.Company Name - Apple, Inc.

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No location provided

Full-time

Do you love creating elegant solutions to highly complex challenges? Do you intrinsically see the importance in every detail? As part of our Silicon Technologies group, you'll help design and manufacture our next-generation, high-performance, power-efficient processor, system-on-chip (SoC). You'll ensure Apple products and services can seamlessly and efficiently handle the tasks that make them beloved by millions. Joining this group means you'll be responsible for crafting and building the techn

Sr. Silicon Validation Engineer, SERDES (Silicon Engineering)Job Title - Sr. Silicon Validation Engineer, SERDES (Silicon Engineering)

SpaceXCompany Name - SpaceX

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Irvine, California, USA

Full-time

SpaceX was founded under the belief that a future where humanity is out exploring the stars is fundamentally more exciting than one where we are not. Today SpaceX is actively developing the technologies to make this possible, with the ultimate goal of enabling human life on Mars. SR. SILICON VALIDATION ENGINEER, SERDES (SILICON ENGINEERING) At SpaceX we're leveraging our experience in building rockets and spacecraft to deploy Starlink, the world's most advanced broadband internet system. Starl

GNSS Validation EngineerJob Title - GNSS Validation Engineer

Apple, Inc.Company Name - Apple, Inc.

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No location provided

Full-time

Would you like to join Apple's growing wireless silicon development team? Do you like to solve problems? Global Navigation Satellite Systems (GNSS) space vehicles transmit the power of a lightbulb, they are 13,000 miles away and are moving four kilometers per second. The received signals are commonly one hundred times weaker than cosmic microwave background radiation left over from the Big Bang and arrive next to interfering signals ten billion times stronger, just few MHz away. Are you interest