Senior Validation Analyst Jobs

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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 3 days ago | Updated 2 days 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 14 days ago | Updated 1 day 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 3 days ago

Automation Technical Manager- (OT/ PLC / SCADA /Validation /)

Shrive Technologies LLC

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Pennsylvania, USA

Contract, Third Party

Industrial Automation Manager OT/ PLC / SCADA /Validation /Project Management Location :Westpoint, PA key requirements: Bachelor's degree or above, with 5+ years automation system programming and IOT experience Hands on experience such as installation / troubleshooting experience (development, design, and PLC-programming) in Shopfloor Manufacturing systems like OSIPI Data Historian, Siemens PLC, Rockwell system Fluent English, working across time zones and with multicultural teams Core Responsib
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Posted 1 day ago

Validation Engineer

Source Code Technologies LLC

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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 4 days ago

GE EMS Expert / EMS Validation Specialist and RT SCADA

PeakIT

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Remote

Contract

Job Title: RT SCADA to EMS GE EMS Expert / EMS Validation Specialist Location: Remote Job Type: 12 Months Contract Role Overview: We are seeking a highly skilled RT SCADA to EMS Expert with deep experience in GE EMS platforms, real-time data integration, and EMS validation processes. This role will be instrumental in supporting the deployment, integration, and validation of SCADA/EMS systems to ensure secure, stable, and efficient grid operations. Ideal candidates will have a strong background i
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Posted 20 hours 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 30 days 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 18 days ago | Updated 10 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 10 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 5 days ago

Validation Specialist CSV & OT Systems

Galent

•

Muskegon, Michigan, USA

Contract, Third Party

We are seeking a skilled Validation Specialist with hands-on experience in Computer System Validation (CSV) and Operational Technology (OT) systems. The successful candidate will support validation activities across control systems such as DeltaV, ABB DCS, Historian, MES, and other regulated automation platforms. You will work under the direction of the Validation Lead, Automation Lead, and Project Manager, performing validation tasks and ensuring compliance with GxP, FDA, and cGMP guidelines. K
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Posted 3 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 53 days ago | Updated 2 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 1 day ago | Updated 10 hours ago

Automotive Validation Technician - Environmental Testing

BayOne Solutions

•

Torrance, California, USA

Contract

Must Have Ability to work hands onAble to read electrical schematicsElectrical testing/troubleshooting experienceExperience with High Voltage (800 1000V)Experience with Microsoft OfficeHarness Fabrication Nice To Have Build Technician ExperienceMachine shop toolsSolderingTechnical degree in electronics Responsibilities: Set up and run development and validation tests (thermal, vibration, humidity, corrosion, electrical performance) on High Voltage Power ElectronicDocument test results and prov
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Posted 60+ days ago | Updated 23 days ago

Computer System Validation Engineer

Katalyst Healthcares and Lifesciences

•

San Juan, San Juan, Puerto Rico

Full-time

Roles & Responsibilities: Full lifecycle validation for all applicable computerized systems, ensuring they are designed, validated, operated and retired in compliance with GxP regulation and computer system validation (CSV) guidance. Compiling and maintaining accurate CSV documentation, ensuring full traceability throughout system lifecycles. Compliance Analysis, Validation Planning, Risk Assessments. Test planning and strategy. creation and execution of test protocols, scripts and reports.
Posted 60+ days ago | Updated 10 hours ago

Validation - Project Manager

Futran Solutions

•

Seattle, Washington, USA

Full-time

Job Description: Location: Seattle-Dexter, WA*Hybrid Top Skills: - Experience in the Biotech/Cell Therapy industry Preferred - PMP Experience Preferred - Experience with Smartsheets, Tableau, and MS Projects - Strong organizational skills, ability to multi-task and work in a dynamic, fast paced environment. The Project Manager is closely partnered with the GMS&T Leader to enable effective execution of strategy and plans. The scope of responsibilities of the Project Manager fall into 4 general c
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Posted 60+ days ago | Updated 3 days ago

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
Posted 60+ days ago | Updated 10 hours ago

Validation Lead

TechDigital Corporation

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King of Prussia, Pennsylvania, USA

Third Party, Contract

Computer System Validation, Computed system assurance, GAMP, GxP risk assessments, Change Management 10+ years' Experience in Validating systems and Experienced in CSV activities in GxP related applications like SAP Systems, Product Serialization systems, MES systems Perform review for GxP systems to ensure compliance with regulatory requirements Working knowledge on end-to-end validation of GxP applications and is able to perform document/process Compliance Analysis Adept with Agile and Waterf
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Posted 17 days 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 10 hours 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 2 days ago | Updated 10 hours ago