21 cfr part 11 jobs in san jose, ca

Project Manager/ Business Analyst (Clinical Operations)

Hybrid in Foster City, California

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4d ago

Job Title: Project Manager/ Business Analyst (Clinical Operations) Location: Foster City, CA (Hybrid)Employment Type: Full-Time (FTE) Job SummarySeeking a Senior Project Manager / Business Analyst with strong Clinical Operations expertise and hands-on experience in Risk-Based Monitoring (RBM/RBQM). Responsible for requirements gathering, project delivery, stakeholder management, and implementation of clinical systems and monitoring processes. Key ResponsibilitiesLead requirements gathering for R

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Full-time

$160,000 - $160,000

Computer System Validation (CSV) in life sciences

Remote

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Yesterday

Validation Lead Wilmington, DE (Onsite / Hybrid) Computer System Validation (CSV) in life sciences R&D is a structured process that proves software and automated systems consistently perform as intended while meeting regulatory standards like GxP, 21 CFR Part 11, and GAMP 5.

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Third Party, Contract

45 - 50

Loftware Spectrum Technical Lead

Remote

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Yesterday

Role : Loftware Spectrum Technical Lead / Solution Engineer Position Summary Responsible for the technical design, configuration, integration, support, and lifecycle management of Integer's Loftware Spectrum enterprise labeling platform. This role serves as the primary technical resource between Labeling COE, SAP, Oracle, manufacturing sites, Quality, and implementation partners to ensure a scalable, compliant, and supportable global labeling solution. The individual will lead architecture, busi

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Contract, Third Party

Depends on Experience

Loftware Spectrum Technical Lead / Solution Engineer

Remote

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12d ago

At NTT DATA, we know that with the right people on board, anything is possible. The quality, integrity, and commitment of our employees have been key factors in our company's growth and market presence. By hiring the best people and helping them grow both professionally and personally, we ensure a bright future for NTT DATA and for the people who work here. For more than 25 years, NTT DATA Services have focused on impacting the core of your business operations with industry-leading outsourcing

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Contract

Depends on Experience

Sr. Computer Systems Validation Analyst

Foster City, California

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16d ago

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

Engineer II, Integration

Santa Clara, California

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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

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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11d ago

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 (Compliance) #4942

Sunnyvale, California

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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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25d 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

Veeva Migration Consultant

Remote

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Yesterday

We are looking for 3 strong profiles with hands-on Veeva migration experience. We need candidates who can demonstrate: Hands-on migration of clinical trial data/documents to Veeva, including source-to-target mapping, transformation, cleansing, loading, and reconciliation.Experience with regulated clinical platforms such as CTMS/eTMF/EDC and migration controls covering audit trails, metadata, data integrity, and GxP/21 CFR Part 11 expectations.Experience executing mock/test/production migration c

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Third Party, Contract

Depends on Experience

Veeva Migration Consultant

Remote

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Yesterday

Role: Veeva Migration Consultant Location: 100% Remote Role Summary: Hands-on migration of clinical trial data/documents to Veeva, including source-to-target mapping, transformation, cleansing, loading, and reconciliation.Experience with regulated clinical platforms such as CTMS/eTMF/EDC and migration controls covering audit trails, metadata, data integrity, and GxP/21 CFR Part 11 expectations.Experience executing mock/test/production migration cycles, handling migration defects, and supporting

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Contract, Third Party

$40,000 - $60,000

CSA/CSV Validation Consultant

Remote or Arlington, Virginia

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Yesterday

Role - CSA/CSV Validation Consultant Remote Skills & Experience Required: empower or similar HPLC software Deep expertise in validating GxP-regulated IT systems within the Pharma/Life Sciences domain Familiarity with QMS processes including deviation management, CAPA, and change control. Strong command of CSA (Computer Software Assurance) principles Solid knowledge with 21 CFR Part 11, Annex 11, ISPE AI guidance, GxP data integrity principles (ALCOA+). Proven ability to write and manage valida

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Contract

PLM Windchill Solution Architect/ SME

Remote

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Yesterday

Position SummaryWe are seeking a highly experienced Windchill PLM Subject Matter Expert to assess the current PTC Windchill environment and develop a strategic upgrade roadmap for Windchill 2027. The ideal candidate will have strong technical and functional expertise in Windchill, PLM transformation, system upgrades, data migration, and integrations within regulated industries, preferably Medical Devices. Key ResponsibilitiesAssess the existing Windchill environment, including configurations, cu

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Third Party, Contract

Depends on Experience

Product Owner

Remote

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11d ago

Role OverviewThe Product Owner for the Clinical Trial Platform is responsible for defining the product vision, strategy, and roadmap for technology that supports end to end clinical trial execution.This role blends product management discipline with deep understanding of regulated clinical workflows, ensuring the platform delivers measurable value to sponsors, CROs, research sites, and patients. The PM drives feature development across study startup, patient identification, eligibility, randomiz

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Third Party, Contract

$80 - $85

PLM Windchill Solution Architect/ SME

Remote

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3d ago

Role : PLM Windchill Solution Architect/ SME Location : Remote Type : Contract Required Skills & Experience Windchill Expertise 12+ years of hands-on experience with PTC Windchill. Expertise across: Windchill PDMLink ProjectLink MPMLink PartsLink Change Management Document Management Configuration Management Strong knowledge of Windchill versions 12.x/13.x and roadmap toward Windchill 2027. Experience with Windchill upgrades, migrations, and modernization programs. Technical Skills

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Contract, Third Party

Depends on Experience

Product Owner

Remote

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19d 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

Computer Vision Engineer

Remote

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3d ago

Role: Computer Vision EngineerLocation: Remote with travel required 50%Duration: 6months with possible extensionRole OverviewWe are seeking a Computer Vision Engineer to own the development and integration of real-time automated visual inspection systems for our pharmaceutical packaging lines. In this role, you will design and deploy edge-based vision models that interface with high-speed cameras and IoT hardware to detect packaging defects, verify serialization, and ensure 100% quality complian

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Contract

Depends on Experience

Clinical Trial Product Owner

Remote

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9d ago

We are hiring for a Product Owner. It s a long-term contract role // Fully Remote role. Title : Product Owner Work Schedule: Fully Remote role. Required Skills : Product Owner with Pharma or Clinical Trial Platform Please email me your resume at Role Overview The Product Owner for the Clinical Trial Platform is responsible for defining the product vision, strategy, and roadmap for technology that supports end to end clinical trial execution. This role blends product owner discipline with deep

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Full-time

Depends on Experience

21 cfr part 11 jobs in San Jose, CA, USA