process validation engineer Jobs

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Validation Engineer

Katalyst Healthcares and Lifesciences

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Piscataway, New Jersey, USA

Full-time

Position Overview: Looking for an individual with experience in validations particularly with USP Water, chiller (utilities) and C&S. Responsibilities: Generation of qualification / validation documents, execution of qualification / validation documents, generation of reports, adhering to project timelines, ensure compliance with company and industry standards and participating in cross-functional teams. Required Skills: Experience with drafting and executing IQ / OQ / PQ. CAD proficiency to
Posted 8 days ago | Updated 3 hours ago

Lab Validation Engineer

Katalyst Healthcares and Lifesciences

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Tarrytown, New York, USA

Full-time

Responsibilities: CM is looking for candidates that have experience with laboratory equipment qualifications, writing life cycle documents, drafting deviations, and are familiar with part 11 and DIA. A big part of this role is knowing the DIA (Data Integrity Assessment part 11) Knowing how to write an IOQ and execute it. IF they can do that the CM thinks they can cross over to other areas and can use that in both fill/finish and lab equipment. Please understand that this is an on-the-floor job.
Posted 8 days ago | Updated 3 hours ago

Validation Engineer II

Katalyst Healthcares and Lifesciences

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Athens, Georgia, USA

Full-time

Responsibilities: Perform Smoke studies and assist in semiannual Media fill qualifications as a SME Perform requalification/periodic review of autoclaves, depyrogenation tunnels, cold rooms, freezers, and warehouse areas. Has worked with Ellabs data loggers and software. Write and execute protocols and complete final reports. Understanding of cleaning validation concepts and principles. Understands pharma grade utilities (water HVAC, gases). Requirements: Support Maintenance, Engineering
Posted 8 days ago | Updated 3 hours ago

Validation Engineer

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
Posted 8 days ago | Updated 3 hours ago

Validation Engineer

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-functi
Posted 8 days ago | Updated 3 hours ago

Validation Engineer

Katalyst Healthcares and Lifesciences

•

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
Posted 8 days ago | Updated 3 hours ago

Senior Validation Engineer

Katalyst Healthcares and Lifesciences

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Indianapolis, Indiana, USA

Full-time

Responsibilities: Lead the development and execution of commissioning, qualification, and validation protocols for a range of laboratory equipment, facility systems, and utilities. Draft, review, author, and deploy all required validation documentation including IQ/OQ/PQ protocols, reports, master plans, risk assessments, procedures, reports, and so on. Provide technical expertise throughout the validation lifecycle including risk assessment, deviation investigation, and change control activiti
Posted 8 days ago | Updated 3 hours ago

Validation Engineer

Katalyst Healthcares and Lifesciences

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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
Posted 8 days ago | Updated 3 hours ago

Validation Engineer

Katalyst Healthcares and Lifesciences

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Charlotte, North Carolina, USA

Full-time

Roles & Responsibilities: t least a bachelor's degree (or equivalent experience) in Computer Science, Software/Electronics Engineering, Information Systems, or closely related field is required. Develop and execute validation plans, protocols, and test scripts for equipment, processes, and systems. Collaborate with cross-functional teams to establish validation strategies. Perform Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). Conduct testing
Posted 8 days ago | Updated 3 hours ago

Sr. Silicon Validation Engineer, SERDES (Silicon Engineering)

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
Posted 13 days ago | Updated 3 hours ago

Mid/Senior Level Validation Specialist/Engineer

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
Posted 8 days ago | Updated 3 hours ago

GNSS Validation Engineer

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
Posted 8 days ago | Updated 3 hours ago

Sr. Systems Development Engineer, Antenna System Validation, Kuiper

Amazon Kuiper Manufacturing Enterprises LLC

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Redmond, Washington, USA

Full-time

Project Kuiper is an initiative to increase global broadband access through a constellation of 3,236 satellites in low Earth orbit (LEO). Its mission is to bring fast, affordable broadband to unserved and underserved communities around the world. Project Kuiper will help close the digital divide by delivering fast, affordable broadband to a wide range of customers, including consumers, businesses, government agencies, and other organizations operating in places without reliable connectivity. Key
Posted 15 days ago | Updated 6 hours ago

Analytical Test Method Validation Engineer

Katalyst Healthcares and Lifesciences

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South Plainfield, New Jersey, USA

Full-time

Develop, validate, and implement analytical test methods for combination products in compliance with regulatory standards and internal quality requirements. Collaborate cross-functionally with device engineers, laboratory teams, and quality departments to ensure alignment and successful execution of test method validation (TMV) activities. Provide expert guidance on analytical strategies for device-related products, ensuring robust and reproducible methods are established. Evaluate and optimize
Posted 8 days ago | Updated 3 hours ago

Sr. Systems Development Engineer, Antenna System Validation, Kuiper

Amazon Kuiper Manufacturing Enterprises LLC

•

Redmond, Washington, USA

Full-time

Project Kuiper is an initiative to increase global broadband access through a constellation of 3,236 satellites in low Earth orbit (LEO). Its mission is to bring fast, affordable broadband to unserved and underserved communities around the world. Project Kuiper will help close the digital divide by delivering fast, affordable broadband to a wide range of customers, including consumers, businesses, government agencies, and other organizations operating in places without reliable connectivity. Key
Posted 15 days ago | Updated 6 hours ago

Validation Engineer NPI

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
Posted 8 days ago | Updated 3 hours ago

Software Engineer, High Voltage Systems Validation

Tesla Motors

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Palo Alto, California, USA

Full-time

Tesla is looking for a highly motivated individual to join the Vehicle Software organization's Systems Validation Team with a focus on high voltage systems including battery management, AC and DC charging, and HV power conversion. It is the responsibility of this team to validate all software driven, system level, vehicle requirements prior to any new hardware or software release or new product introduction. As a Systems Validation Engineer, you are expected to be an expert in your domain, have
Posted 14 days ago | Updated 6 days ago

Sr. Network Validation Engineer

SUPERMICRO COMPUTER INC

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San Jose, California, USA

Full-time

Job Req ID: 26373 About Supermicro: Supermicro is a Top Tier provider of advanced server, storage, and networking solutions for Data Center, Cloud Computing, Enterprise IT, Hadoop/ Big Data, Hyperscale, HPC and IoT/Embedded customers worldwide. We are the #5 fastest growing company among the Silicon Valley Top 50 technology firms. Our unprecedented global expansion has provided us with the opportunity to offer a large number of new positions to the technology community. We seek talented, pass
Posted 13 days ago | Updated 3 hours ago

Software Engineer: Validation of Crypto and Security IPs

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
Posted 8 days ago | Updated 3 hours ago

Senior SATCOM Validation Engineer - Mobility Terminal, Customer Terminal

Amazon Kuiper Manufacturing Enterprises LLC

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Redmond, Washington, USA

Full-time

Project Kuiper is an initiative to launch a constellation of Low Earth Orbit satellites that will provide low latency, high-speed broadband connectivity to unserved and underserved communities around the world. Come work at Amazon!Key job responsibilitiesSatellite Terminal Validation Engineer, you will be responsible for Customer Terminal (CT) integration and validation with hardware, software, and firmware. You will be working in a collaborative environment with a multi-disciplinary team. In th
Posted 15 days ago | Updated 6 hours ago