21 CFR Part 11 jobs in California

San Francisco, California

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7d ago

Title: Validation Lead CoreAI Location: San Francisco, CA We drive and realise cell and gene therapies by translating scientific progress into life-changing experiences for patients. Global Reputation for industry-leading contributions Cell and Gene Therapy powerhouse at Roche Driver of life-changing treatment for patients Talent destination and incubator Partner of choice and Pioneer in a new era in medicine About the role: In Pharma Technical Operations (PT), Roche is advancing a cutting-

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Contract

Depends on Experience

Loftware Spectrum Technical Lead

Remote

•

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

Windchill Solution Architect/Senior Windchill PLM Consultant Medical Device Industry

Remote

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14d ago

Position Title: Windchill Solution Architect/Senior Windchill PLM Consultant Experience: 12+ Years Location: Flexible / Hybrid Domain: Medical Devices (additionally we can look at candidates from Life Sciences, Healthcare domain as well but preference shall be for candidates with Medical Devices domain background) Employment Type: Full Time / Contract Position Summary We are seeking a highly experienced Windchill PLM Subject Matter Expert (SME) to lead the assessment and strategic planning for a

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Contract, Third Party

80 - 90

GxP Project Manager (Pharma)

Hybrid in San Francisco, California

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6d ago

Job Title: GxP Project Manager Location: Bay Area, CA Duration: 6+ months with possible of extension Required Qualifications Bachelor's degree in Engineering, Computer Science, Life Sciences, Pharmacy, Biotechnology, or related field.8+ years of Project Management experience within the Pharmaceutical or Biotechnology industry.5+ years managing GxP-regulated projects.Strong understanding of GMP, GxP, GAMP 5, FDA regulations, and 21 CFR Part 11.Experience managing Computer System Validation (CSV)

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Contract, Third Party

$80 - $90

TIBCO Statistica specialist

Vacaville, California

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Today

We are currently seeking a Statistical Software Configuration Specialist (Statistica TIBCO) for a 612+ month contract based in Vacaville, CA. This role follows a balancing data analytics work with on-site manufacturing support and collaboration. Position Overview: The Statistical Software Configuration Specialist is responsible for configuring, optimizing, and maintaining the TIBCO Statistica platform to support enterprise-level analytics, workflow automation, and data-driven decision-making. T

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Contract, Third Party

Depends on Experience

Principal Solution Architect – Cloud, IoT & Agentic AI

Remote

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Today

Role- Principal Solution Architect Cloud, IoT & Agentic AI Location Remote Key Responsibilities 1. Enterprise & Solution Architecture Define and own the end-to-end target architecture and technical roadmap for the next-generation remote instrument monitoring platform. Design a scalable, modular, cloud-native architecture comprising Application, Transport, and Processing layers. Establish architectural principles, integration patterns, interface contracts, versioning strategies, and ownershi

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Contract

Depends on Experience

Core Java and Full Stack Application Developer QMS Developer

Sunnyvale, California

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14d ago

Job Title : Senior AI Software Engineer QMS Developer Location : Sunnyvale, CA - Fully onsite (5 days) Duration :1 year 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 application workloads (Bedrock/SageMaker, Lambda,

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Contract

80 - 85

Loftware Spectrum Technical Lead / Solution Engineer

Remote

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29d 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, California

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8d 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 pro

Full-time

Sr. Computer Systems Validation Analyst

Foster City, California

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8d ago

Full-time

Veeva Migration Consultant

Remote

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5d ago

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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Contract, Third Party

Depends on Experience

Business Analyst - Veeva Migration

Remote

•

Yesterday

Job Title : Business Analyst - Veeva Migration Job Location: REMOTE Must have hands-on Business Analyst experience in Veeva migration.Hands-on experience with Veeva CTMS, eTMF, and EDC is mandatory.Experience in migration requirements, source-to-target mapping, data validation, and reconciliation is preferred.Hands-on migration of clinical trial data/documents to Veeva, including source-to-target mapping, transformation, cleansing, loading, and reconciliation.Experience with regulated clinical

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Contract

50 - 60

Clinical Data Analyst

Remote or New Jersey

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8d ago

Key Responsibilities: Develop, maintain, and execute SAS programs to support external data transfers, including validation against vendor transfer specifications Generate and maintain Data Review Listings (DRLs) and Study Health Metrics (SHMs) in accordance with study timelines Perform peer review of DRLs and data reconciliation reports Monitor automated job logs and resolve issues as needed Retrieve and post external vendor data using sFTP/FTP clients and vendor portals Collaborate with data ma

Full-time

Senior Engineering/ IT Program Manager

Remote or Ponce, Ponce

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Today

Job Title: Senior Engineering/ IT Program Manager Client: Medical Device Manufacturing Company Duration: 12 Months Location: 100% Remote (Travel to Ponce, Puerto Rico as needed) Role Overview Lead large cross-functional engineering programs Support manufacturing, digital transformation, and regulated systems Work across Engineering, Manufacturing, Quality, Regulatory, and IT Program Leadership Manage enterprise engineering programs Build roadmaps, milestones, and resource plans Deliver withi

Full-time

Computer System Validation Engineer

San Diego, California

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8d ago

Job Summary: We are seeking a motivated and detail-oriented Computer System Validation (CSV) Engineer with 1-2 years of experience to support validation and compliance activities within the Pharmaceutical and Medical Devic e industries. The ideal candidate will assist with the validation of computerized systems in regulated GxP environments and ensure systems comply with applicable regulatory and quality requirements. The candidate should have a strong understanding of validation principles, doc

Full-time

Salesforce Marketing Cloud Technical Consultant / Lead

Alameda, California

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20d ago

Position: Salesforce Marketing Cloud Technical Consultant / Lead Location: Alameda, CA (Onsite) Duration: 06 Months (Extendable) 4-8 years of experience. Salesforce Marketing Cloud, CRM platforms. Must have: Experience supporting campaign execution, platform optimization, integrations, and reporting. Fully involved in Marketing Function, skilled in Marketing Cloud Development as well. Must Report to Client Alameda, California Office Role Descriptions: Strong working knowledge of Sales Cloud

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Contract, Third Party

50 - 60

Validation Tester (CoreAI PTC)

San Francisco, California

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7d ago

Job Title Validation Tester (CoreAI PTC) Location: San Francisco, CA About Roche CoreAI PTC We drive and realize Cell and Gene Therapies (CGT) by translating scientific progress into life-changing experiences for patients. Our key strengths include: Global reputation for industry-leading contributions.Cell and Gene Therapy powerhouse at Roche.Driver of life-changing treatments for patients.Talent destination and incubator.Partner of choice and pioneer in a new era of medicine. About the Role J

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Contract

Depends on Experience

Clinical Trial Product Owner

Remote

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26d 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

Windchill Solution Architect

Remote

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20d ago

Job Description: Summary Seeking an experienced Windchill PLM SME to assess the current PTC Windchill landscape and define the upgrade strategy and roadmap for Windchill 2027. Preference for candidates with a strong Medical Devices background; Life Sciences and Healthcare experience will also be considered. Responsibilities Assess existing Windchill configuration, customizations, workflows, data models, infrastructure, and integrations.Evaluate Windchill 2027 readiness, upgrade risks, technical

Contract

$100 - $130

Veeva CRM Techno-Functional Consultant

Remote

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6d ago

Veeva CRM Techno-Functional Consultant Job Summary We are seeking an experienced Veeva CRM Techno-Functional Consultant with strong expertise in Veeva CRM, Salesforce, and pharmaceutical commercial operations. The ideal candidate should have hands-on experience in Veeva CRM configuration, customization, integrations, business requirements gathering, and end-to-end implementation and support. Key Responsibilities Work closely with business stakeholders to gather, analyze, and translate business r

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Third Party, Contract

Depends on Experience

21 CFR Part 11 jobs in California, USA