No se aceptan más aplicaciones
Validation Engineer - GxP Systems
Staftonic LLCSan Jose, CA, USHace 1 día
Tipo de contrato
- A tiempo completo
Descripción del trabajoBachelor’s degree in Engineering, Computer Science, IT, or Life Sciences. 6+ years of experience in medical device or regulated industry; 3+ years in software validation. Strong knowledge of GAMP 5, Part 11, Annex 11, and cloud / SaaS validation. Proficiency in Microsoft Office, Google Suite, Jama, eQMS / ePLM. Excellent communication and teamwork skills. Preferred Certifications : GAMP Practitioner, PMP, ASQ-CQA.
Job Description
Job Title : Validation Engineer – GxP Systems
Location : San Francisco Bay Area
Long Term Project
Key Responsibilities :
- Lead and manage CSV (Computer System Validation) for GxP systems across Quality, Manufacturing, Clinical, and Business areas.
- Develop and maintain validation procedures, templates, and master validation plans.
- Prepare and review validation documentation (plans, protocols, reports).
- Ensure compliance with GAMP 5, 21 CFR Part 11, and ISO 13485.
- Collaborate with cross-functional teams (IT, QA, Engineering, Manufacturing, Clinical).
- Support change control, audits, CAPA, and document control processes.
- Mentor junior team members on data integrity and validation best practices.
Qualifications :
Crear una alerta de empleo para esta búsqueda
Validation Engineer • San Jose, CA, US
Ofertas relacionadas
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...Mostrar másÚltima actualización: hace más de 30 días 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...Mostrar másÚltima actualización: hace más de 30 días 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...Mostrar másÚltima actualización: hace más de 30 días 
Key responsibilities in your new role : .Validation of silicon, system and firmware against requirements / customer requirements.
Developing test automation for the power stage silicon and system.Work t...Mostrar másÚltima actualización: hace 5 días
Verification and Validation Engineer / Senior V&V Engineer.Conduct design verification and validation testing for product development activities.
Support all technical aspects of the product and i...Mostrar másÚltima actualización: hace más de 30 días
Senior Principal System Validation Engineer at Astera Labs (NASDAQ : ALAB).Astera Labs provides rack-scale AI infrastructure through purpose-built connectivity solutions grounded in open standards.B...Mostrar másÚltima actualización: hace 5 días
We're ALTEN Technology USA, an engineering company helping clients bring groundbreaking ideas to life—from advancing space exploration and life-saving medical devices to building autonomo...Mostrar másÚltima actualización: hace 7 días
Quantum computing holds the promise of humanity's mastery over the natural world, but only if we can build a.PsiQuantum is on a mission to build the first real, useful quantum computers, capable of...Mostrar másÚltima actualización: hace más de 30 días Astera Labs (NASDAQ : ALAB) provides rack-scale AI infrastructure through purpose-built connectivity solutions grounded in open standards.
By collaborating with hyperscalers and ecosystem partners, A...Mostrar másÚltima actualización: hace más de 30 días Astera Labs (NASDAQ : ALAB) provides rack-scale AI infrastructure through purpose-built connectivity solutions grounded in open standards.
By collaborating with hyperscalers and ecosystem partners, A...Mostrar másÚltima actualización: hace más de 30 días 
Cupertino, California, United States Hardware.Imagine what you could do here.At Apple, new ideas have a way of becoming extraordinary products that delight millions.
The silicon engineering team is ...Mostrar másÚltima actualización: hace 5 días
Validation Engineer, Chassis Systems, Vehicle Software.Validation Engineer, Chassis Systems, Vehicle Software.The Chassis Systems Software team is looking for an engineer to own the validation of e...Mostrar másÚltima actualización: hace más de 30 días
Software quality assurance or software validation.Preferably within the medical device industry.Strong knowledge of FDA 21 CFR Part 820, ISO 13485, IEC 62304.
Experience in non-product software vali...Mostrar másÚltima actualización: hace 5 días
CAI is a professional services company established in 1996 that has grown to nearly 800 people worldwide.For mission-critical and regulated industries needing to deliver essential solutions in high...Mostrar másÚltima actualización: hace 17 días
San Francisco Bay Area, California, United States Hardware.In this highly visible role, you will be at the center of a silicon design group with a critical impact on getting functional wireless pro...Mostrar másÚltima actualización: hace 9 días 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 manuf...Mostrar másÚltima actualización: hace más de 30 días 
We believe in using space to help life on Earth.Planet designs, builds, and operates the largest constellation of imaging satellites in history.
This constellation delivers an unprecedented dataset ...Mostrar másÚltima actualización: hace más de 30 días
This is not a software role • • •.The focus will be mechanical / medical device testing and V&V protocols through simulated use studies in partnership with surgeons.
Design Verification & Valid...Mostrar másÚltima actualización: hace más de 30 días
- Oferta promocionada
System Validation Engineer
SupermicroSan Jose, CA, United StatesA tiempo completo
- Oferta promocionada
Application Validation Engineer
SupermicroSan Jose, CA, United StatesA tiempo completo
- Oferta promocionada
Hardware Validation Engineer
SupermicroSan Jose, CA, United StatesA tiempo completo
- Oferta promocionada
Senior Validation Engineer
Infineon Technologies AGSan Jose, CA, United StatesA tiempo completo
- Oferta promocionada
Verification and Validation Engineer / Senior V&V Engineer
Bayside SolutionsSan Mateo County, CA, USA tiempo completo +1
- Oferta promocionada
Senior Principal System Validation Engineer
Astera LabsSanta Clara, CA, United StatesA tiempo completo
- Oferta promocionada
Validation Engineer, Traceability
ALTEN Technology USAFoster City, CA, USA tiempo completo
- Oferta promocionada
Validation Engineer, Cryogenic
PsiQuantumMilpitas, CA, United StatesA tiempo completo
- Oferta promocionada
Senior Principal System Validation Engineer (AI Fabric Switches)
Astera LabsSan Jose, CA, United StatesA tiempo completo
- Oferta promocionada
Senior System Validation Engineer - SerDes / Ethernet (PAM4)
Astera LabsSan Jose, CA, United StatesA tiempo completo
- Oferta promocionada
System Validation Engineer
AppleCupertino, CA, United StatesA tiempo completo
- Oferta promocionada
Validation Engineer, Chassis Systems, Vehicle Software
TeslaPalo Alto, CA, United StatesA tiempo completo
- Oferta promocionada
Validation Engineer
Katalyst Healthcares and Life SciencesSanta Clara, CA, United StatesA tiempo completo
- Oferta promocionada
Validation Engineer
CAISan Francisco, CA, USA tiempo completo
- Oferta promocionada
Firmware Validation Engineer
Apple Inc.San Francisco, CA, United StatesA tiempo completo
- Oferta promocionada
Silicon Validation Engineer
AppleCupertino, CA, United StatesA tiempo completo
- Oferta promocionada
Senior FPGA Verification Engineer
Planet Labs PBCSan Francisco, CA, United StatesA tiempo completo
- Oferta promocionada
Verification Validation Engineer, Medical Device
SciProSan Mateo, CA, USA tiempo completo