validation support engineer Jobs

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Validation Support Engineer

Katalyst Healthcares and Lifesciences

•

Johns Creek, Georgia, USA

Full-time

Roles & Responsibilities: Validation Planning: Develop/update Master Validation Plans (MVP) and individual Validation Plans (VP) for system changes. Required: Proven expertise in CSV (Computer System Validation) methodologies (e.g., GAMP5), FDA regulations (21 CFR Part 11, 210, 211, 820 as applicable), and validation of automated manufacturing/control systems. Experience validating PLC-based systems (Beckhoff Twin CAT experience is a significant plus). Responsibilities: Perform tasks under S
Posted 56 days ago | Updated 2 hours ago

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
Posted 49 days ago | Updated 2 hours ago

QC Validation Support Specialist Carlsbad, CA Onsite

MARVEL INFOTECH Inc

•

Carlsbad, California, USA

Contract, Third Party

QC Validation Support Specialist Contract Location: 100% Onsite Carlsbad, CA Local to California only Must have: Pharma/Biotech/Medical Device, IQ/OQ/PQ, GxP / cGMP, Commissioning and Qualification Background: The Radioligand Therapy (RLT), Carlsbad site is installing new instruments and software in the laboratory that will require validation work for the new QC lab. As a part of the onboarding of new QC equipment and instruments for the project, multiple QC instruments, and QC support equipme
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Posted 2 days ago | Updated 2 days ago

Hardware Validation Engineer- Irvine CA

Belcan Services Group, Limited Partnership

•

Irvine, California, USA

Contract

Job Title: Hardware Validation Engineer Location: 14600 Myford Road, Irvine CA 92606 Duration: 12 months Pay Rate: $55/hr. Job Description: Responsibilities: Validation Planning & Criteria Development: Develop and manage comprehensive validation plans for mechatronic systems and sub-systems, ensuring all design and performance requirements are met.Establish testing criteria for accurate and reliable results, including sample size, statistical analysis, and attribute vs. variable testing.Test Pla
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Posted 4 days ago

Sensing HW Validation Engineer (Test Engineer III)

WinMax Systems Corporation

•

Cupertino, California, USA

Contract

Job Title: Sensing HW Validation Engineer (Test Engineer ) - 36081285 Job Duration: 12+ Months Job Location: Cupertino, CA - Fully Onsite Job Summary: The Sensing HW team develops groundbreaking sensors that are central to a variety of Client's platforms, including iPhones, iPads, Audio, Macs, the Home ecosystem, and accessories. You will play a key role in developing, characterizing, and validating sensor systems used in these platforms. The ideal candidate will have expertise in touch sensin
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Posted 52 days ago | Updated 1 day ago

Validation Engineer

Source Code Technologies LLC

•

Sunnyvale, California, USA

Contract

Role name: Validation Engineer Branch | City | Location: Sunnyvale/ Santa Clara, CA Duration: 6 Months Keywords: Key Words to search in Resume Computer System Validation, 21 CFR Part 11, GxP, FDA, 21 CFR Part 11, ISO 13485, IEC 62304 Role Description: Develop, implement, and maintain software quality assurance processes for non-product software used in medical device development.Ensure adherence to regulatory standards (FDA, ISO 13485, IEC 62304) and industry best practices for non-product sof
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Posted 3 days ago

IQ/OQ/PQ Validation Engineer with Medical (W2 Only)

Sovereign Technologies

•

Irvine, California, USA

Full-time

Title: Sr. Validation engineer with Medical Device Candidates Location: Onsite in Irvine, CA Duration: 2+ years 1) Word copy of resume 2) 2-3 professional references THIS IS NOT A SOFTWARE POSITION Looking for hands on IQ/OQ/PQ Validation in Medical Device Candidates MUST HAVE Bachelor of Science in Engineering or a related subject with 4+ years of experience in validation GMPs.Good understanding of engineering and machine tool fundamentals.Written and owned the validation processSME on IQ/OQ/PQ
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Posted 2 days ago

Need - Computer Software Validation (CSV) Engineer

ASCII Group LLC

•

Santa Clara, California, USA

Contract, Third Party

Hi, The following requirement is open with our client. Title : Computer Software Validation (CSV) Engineer Location : Santa Clara, CA (ONSITE) Duration : 12+ Months Relevant Experience (in Yrs.) : 8+ Job Description: Minimum of 4-5 years of experience in software quality assurance or software validation, preferably within the medical device industry.Strong understanding of quality standards and regulatory requirements (e.g., FDA 21 c, ISO 13485, IEC 62304).Experience with non-product software v
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Posted 4 days ago

System Validation Engineer

Katalyst Healthcares and Lifesciences

•

Santa Clara, California, USA

Full-time

Responsibilities: Develop, implement, and maintain software quality assurance processes for non-product software used in medical device development. Ensure adherence to regulatory standards (FDA, ISO 13485, IEC 62304) and industry best practices for non-product software. Support audits and inspections by regulatory bodies, ensuring that non-product software systems comply with quality and documentation standards. Ensure computerized systems are appropriately validated Assessment of applicabi
Posted 13 hours ago | Updated 2 hours ago

FPGA Validation Engineer (Vivado)

Mirafra Inc

•

San Jose, California, USA

Full-time

Develop and execute post silicon Validation and Characterization for clocking circuits on in some of the industry s largest and most complex SOCs (using Xilinx s FPGA design tools such as Vivado/ISE).Hands-on experience with lab equipment such as oscilloscopes, logic analyzers,Thermosteamer, Clock generators and other equipment.Expert knowledge and hands-on experience of the entire backend and adjacent flows, including synthesis, Floor-planning P&R, clocking, timing closure, power, and IO plann
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Posted 13 days ago | Updated 7 hours ago

Validation Engineer

Katalyst Healthcares and Lifesciences

•

Summit, New Jersey, USA

Full-time

Responsibilities: Maintains all qualified and validated equipment and systems in compliance with policies, guidelines and procedures. Develops protocols, and associated reports while adhering to a change management process. Supports the execution of equipment qualifications and validation protocols. Supervises vendors for qualification functions. Supports equipment qualification and systems validation activities. Configures and documents the configuration of computerized systems. Develops
Posted 7 days ago | Updated 2 hours ago

SUD Validation Engineer

Thermo Fisher Scientific

•

Logan, Utah, USA

Full-time

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing so
Posted 17 days ago | Updated 2 hours ago

Silicon Validation Engineer

Sivaltech

•

San Jose, California, USA

Full-time, Third Party

Job Summary: We're looking for silicon validation engineers to drive pre-silicon and post-silicon validation of SerDes and High-Speed interfaces for automotive products. You'll develop test plans, test cases, and automation scripts using Python, and collaborate with design, DV, and firmware teams. Responsibilities: - Develop validation test plans and methodologies - Create test cases and automation scripts using Python - Develop low-level drivers for Windows and Linux OS - Collaborate with tea
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Posted 9 days ago

WiFi/CPE Validation Engineer (Octoscope/Veriwave)

Yoh - A Day & Zimmerman Company

•

Sunnyvale, California, USA

Full-time

WiFi/CPE Validation Engineer Looking for a WiFi Validation Engineer to handle performance testing for routers and extenders. This person must have experience with Octoscope and/or Veriwave - RF Chambers, and be able to write TR-069/TR-181 related scripts. (Octoscope is for OTA testing and Veriwave is for conductive testing). Required: Previous experience with WiFi performance testing is a must have. Octoscope and/or Veriwave is a must have. Octoscope is for OTA testing and Veriwave is for conduc
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Posted 28 days ago | Updated 3 hours ago

QC Validation Support Specialist - Pharma/Biotech/Medical Device, IQ/OQ/PQ, GxP / cGMP, Commissioning and Qualification

TechSynergy Sources

•

Carlsbad, California, USA

Contract

Must have: Pharma/Biotech/Medical Device, IQ/OQ/PQ, GxP / cGMP, Commissioning and Qualification Background: The Radioligand Therapy (RLT), Carlsbad site is installing new instruments and software in the laboratory that will require validation work for the new QC lab. As a part of the onboarding of new QC equipment and instruments for the project, multiple QC instruments, and QC support equipment will require validation/qualification work to meet QC testing demands. Equipment including but not l
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Posted 3 days ago

Software Validation Engineer - R&D - Machines

Pro Talent Crafter

•

Johns Creek, Georgia, USA

Contract, Third Party

Role: Software Validation Engineer - R&D - Machines Location: Johns Creek, GA Job Description: Execute validation plans and protocols for R&D projects affecting facilities, equipment, processes, cleaning, and software systems.Perform qualification of equipment such as ovens, sterilizers, HPLC/UPLC systems, molding machines, refrigerators, and freezers.Conduct temperature mapping and environmental monitoring of critical systems.Lead cleaning validation and utility qualification efforts.Write and
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Posted 29 days ago

Principal Verification and Validation Engineer

BAE Systems

•

Potomac, Maryland, USA

Full-time

Job Description BAE Systems is seeking a full-time Principal Verification and Validation Engineer to support our work as a prime contractor on a high-profile U.S. Navy weapon system. The candidate will help guide and determine the verification approach for our Systems Engineering team as it incorporates Model Based Systems Engineering (MBSE) tools and methodologies to support the UK TRIDENT Submarine Strategic Weapon System (SWS) program. The ideal candidate would be self-motivated, good at pla
Posted 20 days ago | Updated 1 day ago

Computer System Validation (CSV) Engineer

Katalyst Healthcares and Lifesciences

•

Remote or Massachusetts, USA

Full-time

Responsibilities: Lead and execute CSV activities across GxP-regulated systems (LIMS, MES, ERP, etc. uthor and maintain validation deliverables: URS, FS, DS, IQ, OQ, PQ, and traceability matrices. Ensure systems comply with 21 CFR Part 11, EU Annex 11, and GAMP 5. Support system implementations, upgrades, and periodic reviews. Collaborate with QA, IT, and business users to drive validation strategy. Participate in audits and inspections to demonstrate compliance. Requirements: Bachelor's degree
Posted 1 day ago | Updated 2 hours ago

Validation Engineer

Katalyst Healthcares and Lifesciences

•

Warren, New Jersey, USA

Full-time

Responsibilities: Maintains all qualified and validated equipment and systems in compliance with policies, guidelines and procedures. Develops protocols, and associated reports while adhering to a change management process. Supports the execution of equipment qualifications and validation protocols. Supervises vendors for qualification functions. Supports calibration, equipment qualification and validation activities. Configures and documents the configuration of computerized systems. Dev
Posted 40 days ago | Updated 2 hours ago

Associate Manager, Data Validation Engineer

Takeda pharmaceutical

•

Boston, Massachusetts, USA

Full-time

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description Pursuant to Section 20 C.F.R. 656.10, you are hereby notified that an application for Alien Employment Certification will be filed by
Posted 3 days ago | Updated 2 hours ago