21 CFR Part 11 jobs in San Jose, CA

Manufacturing Data Strategy & Architecture Consultant

Remote

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19d ago

Job title: Manufacturing Data Strategy & Architecture Consultant Location: Remote Position Overview Seeking a senior Manufacturing Data Strategy & Architecture Consultant to support the development of a future-state data vision, strategy, and architecture roadmap. The ideal candidate will bring deep expertise in pharmaceutical manufacturing data ecosystems, industrial data architectures, contextualization, semantics, and GxP-regulated environments. This role will serve as a trusted advisor to Pf

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Full-time, Third Party

Depends on Experience

Sr. Computer Systems Validation Analyst

Foster City, California

•

Today

Summary : We are seeking a Senior Computer Systems Validation (CSV) Analyst with strong experience in GxP-regulated pharmaceutical/life sciences environments. The candidate will be responsible for planning, leading, and executing validation activities for SCADA, Rockwell FactoryTalk, PLCs, and Ignition process control systems. The role requires hands-on expertise in GAMP 5, 21 CFR Part 11, EU Annex 11, validation lifecycle documentation, risk assessments, change controls, and qualification prot

Full-time

Core Java Full-Stack Application Developer

Hybrid in Sunnyvale, California

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9d ago

Job Title : Core Java and Full-Stack Application Development QMS Developer Location : Sunnyvale, CA - Hybrid (3 days) Duration :1 year No of rounds of interview: 2 W2 Candidate Only Top Skills: Strong core Java and full-stack application development in validated GxP environments (Spring Boot, REST APIs, SQL, modern front-end framework)Python-based AI engineering LLM application and agent development (RAG, prompt engineering, orchestration, evaluation)AWS solution architecture for AI and appli

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Contract

80 - 84

Sr QMS Developer

Sunnyvale, California

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15d ago

Maxonic maintains a close and long-term relationship with our direct client. In support of their needs, we are looking for a Sr QMS Developer. Job Description: Job Title:Sr QMS Developer Job Type: Contract Job Location: Sunnyvale, CA Work Schedule: Onsite Pay Rate: $88, Based on experience Description: This is a software engineering role focused on building applications and AI capabilities for our regulated quality systems landscape. The person will design and develop Java-based applications,

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Contract

Depends on Experience

Sr QMS Developer

Sunnyvale, California

•

Yesterday

Position Overview: This is a software engineering role focused on building applications and AI capabilities for our regulated quality systems landscape. The person will design and develop Java-based applications, services and integrations that support GxP processes, and will design, build and support Python-based AI agents that automate and augment those same processes. The emphasis of this role is engineering, not platform configuration. We are looking for a strong developer who can write produ

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Contract

$80 - $85

Veeva RIM Business Analyst

Hybrid in Foster City, California

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3d ago

Role SummaryWe are seeking a Business Analyst with hands-on Veeva Vault RIM experience to support our client's Regulatory Affairs technology and process initiatives.The role partners with Regulatory Operations, IT, and cross-functional stakeholders to gather requirements, define solutions, and support the delivery, enhancement, and adoption of Veeva Vault RIM capabilities.Key ResponsibilitiesPartner with Regulatory Affairs and Regulatory Operations stakeholders to elicit, document, and validate

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Contract, Third Party

Depends on Experience

Engineer II, Integration

Santa Clara, California

•

Today

Work Schedule Standard (Mon-Fri) Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.) Job Description How You Will Make an Impact: The Engineer II, Integration supports the integration, configuration, testing, and commissioning of automation and bioprocessing systems within Product Engineering, ensuring systems are accurately

Full-time

USD 79,200.00 - 105,600.00 per year

GxP Project Manager

Hybrid in Foster City, California

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29d ago

Role Summary The driving force behind constant business growth is the presence of skilled and dedicated project managers. The ideal candidate will have pharma experience with GxP Technical Development or Pharma Biotech experience with strong work plan development and progress oversight skills. He/She will be expected to oversee the planning and implementation of an entire project through budgeting, assessing team members, engage with suppliers and plan the project release. Their duties include s

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Contract, Third Party

$80 - $90

Associate Controls Engineer

Pleasanton, California

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Today

Wunderlich-Malec Engineering has an Associate Controls Engineer opportunity available in Pleasanton, CA. This person would deliver process control systems including DCS/PLC/SCADA/HMI programming, hardware designs, network architecture design, instrumentation/electrical designs, check-out/start-up support, etc. Please Note: This position is not eligible for employer-sponsored work authorization, including H-1B sponsorship. The Company does not participate in the STEM OPT training program for thi

Full-time

USD 85,000.00 - 115,000.00 per year

Senior EDC Global Library Programmer, Medidata Rave (

Redwood City, California

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Today

Greetings from IT Engagements IT Engagements is a global staff augmentation firm providing a wide-range of talent on-demand and total workforce solutions. We have an immediate opening for the below position with one of our premium clients. Role: Senior EDC Global Library Programmer, Medidata Rave (Contract Role) Location: Redwood City, CA (3 days a week onsite) The Opportunity: The Senior EDC Global Library Programmer serves as a technical subject matter expert responsible for the developmen

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Third Party, Contract

Senior / Staff Data Integrity Engineer # 4942

Sunnyvale, California

•

Today

Our mission is to detect cancer early, when it can be cured. We are working to change the trajectory of cancer mortality and bring stakeholders together to adopt innovative, safe, and effective technologies that can transform cancer care. We are a healthcare company, pioneering new technologies to advance early cancer detection. We have built a multi-disciplinary organization of scientists, engineers, and physicians and we are using the power of next-generation sequencing (NGS), population-scal

Full-time

USD 135,000.00 - 180,000.00 per year

Sr Data Engineering Manager

Campbell, California

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Today

Title: Sr Data Engineering Manager This position is based in our Campbell, California offices. This position is on-site, full-time. Why Imperative Care? Do you want to make a real impact on patients? As part of our team at Imperative Care, you can help elevate care for patients suffering from stroke and other devastating vascular diseases. Every day, the technologies that we develop at Imperative Care directly impact people at the most vulnerable moments of their lives. Our focus is on the nee

Full-time

USD 220,000.00 - 245,000.00 per year

SAP Validation

Remote

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10d ago

Job Title: SAP Validation Life Sciences & Pharmaceuticals Location: Remote Duration : Long term ONLY SAP VALIDATION PROFILES Required Qualifications Bachelor s degree in computer science, Information Technology, Engineering, Life Sciences, or related field. 8+ years of experience in SAP validation or Computer System Validation (CSV). GxP regulations 21 CFR Part 11 Annex 11 GAMP 5 Experience with validation tools and documentation management systems. Familiarity with change management and deviat

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Contract

Depends on Experience

Sr Technical Writer

Remote

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4d ago

Hi, Hope you are doing well. Job Title: Sr IT Technical Writer Location: Remote Duration:12+ Months Job Description: We areseeking a Senior IT Technical Writer with 10+ years of experience to support technical documentation initiatives within a Bio-Pharma/Life Sciences environment. The consultant will work closely with IT, engineering, application, infrastructure, quality, validation, and business teams to develop accurate and compliant documentation for regulated systems. The role involves cr

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Contract

Depends on Experience

OT Solutions Architect – MES & SCADA

Remote

•

Today

OT Solutions Architect MES & SCADALocation: USA Remote Role: Application Architect Operations Technology Job SummaryWe are seeking an experienced OT Solutions Architect to design, implement, and govern Manufacturing Execution Systems (MES) and Supervisory Control and Data Acquisition (SCADA) solutions across manufacturing environments. The ideal candidate will have strong expertise in Ignition SCADA, Sepasoft MES, IT/OT integration, industrial cybersecurity, and enterprise architecture. The c

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Contract, Third Party

Depends on Experience

Product Owner

Remote

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4d ago

Iris's direct client, a leader in Healthcare services, looking to hire a strong Product Owner for a Long-Term Contractual role Job title: Product Owner Location: 100% Remote Duration: 18 Months Skills: Product Owner, Clinical Trial Platform Job Description: Product Manager Clinical Trial Platform Role Overview The Product Manager for the Clinical Trial Platform is responsible for defining the product vision, strategy, and roadmap for technology that supports end-to-end clinical trial executio

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Contract

Depends on Experience

Senior Consultant - GxP & Clinical Quality Assurance

Remote

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25d ago

Arthur Lawrence is looking for a Senior Consultant - GxP & Clinical Quality Assurance one our clients project based on Remote. Please find the job description below and send us your updated resume if interested: Must-Have Skills:10+ years of GxP Quality Assurance experience in biopharma, biotech, or medical devices, including 3+ years at Senior Manager or Director level. Hands-on expertise in Google Cloud Platform site audits, CRO governance, TMF management, and FDA BIMO inspections. Strong ex

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Contract, Third Party

$70 - $75

SENIOR PRODUCT OWNER

Remote

•

Today

Hi, Greetings from Iflowsoft Solutions Inc Job title: Product Owner Location: 100% Remote Duration: 18 Months Skills: Product Owner, with Clinical Trial Platform experience-- MUST Job Description: Product Manager Clinical Trial Platform Required Qualifications Bachelors degree in life sciences, engineering, product management, or related field. 12+ years of product management experience, ideally within clinical trials, healthcare technology, or regulated SaaS platforms. Strong understanding of

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Full-time

Depends on Experience

Director, IT SAP Product Lifecycle and Quality

Foster City, California

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Today

At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead's team plays a critical ro

Full-time

USD 226,185.00 - 292,710.00 per year

Sr SampleManager Implementation Engineer

Remote or Indiana

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Today

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Senior SampleManager LIMS Implementation Engineer How will you make an impact? As a Senior SampleManager LIMS Implementation Engineer, you will be a technical expert responsible for the configuration, implementation, integration, and deployment of Thermo Scientific SampleManager LIMS solutions. This role is highly hands-on and focused on translating defined laboratory processes and solution designs into robus

Full-time

USD 93,800.00 - 140,675.00 per year

21 CFR Part 11 jobs in San Jose, CA, USA