21 cfr part 11 Jobs in california

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Veeva Technical Architect with PromoMats Focus

Vigna Solutions Inc.

•

Remote

Contract

Role: Veeva Technical Architect with PromoMats Focus Location: Remote JD Expertise with PromoMats at least two end-to-end PromoMats implementations Required Qualifications: Prior consulting experience.5+ years of hands-on experience with Veeva Vault, including PromoMats, MedComms, Modular Content, DAM, and Claims modules, with at least two end-to-end PromoMats implementations.In-depth knowledge of life sciences regulatory frameworks (e.g., GxP, 21 CFR Part 11), MLR processes, and experience supp
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Posted 8 days ago

System Validation Engineer

Katalyst Healthcares and Lifesciences

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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 7 hours ago

Medical Device & Regulations Engineer

Katalyst Healthcares and Lifesciences

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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 applicabil
Posted 6 days ago | Updated 7 hours 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

CSV Engineer

Katalyst Healthcares and Lifesciences

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Santa Clara, California, USA

Full-time

Job Description: The CSV Engineer will play a critical role in ensuring that all computerized systems used in the manufacturing and quality systems of medical devices are validated according to applicable regulations such as FDA 21 CFR Part 11, EU Annex 11, and ISO 13485. This role ensures the systems are compliant, reliable, and fit for intended use, supporting quality and regulatory requirements across the organization. Responsibilities: Develop and execute Computer System Validation (CSV) de
Posted 6 days ago | Updated 7 hours ago

Computer System Validation (CSV) Engineer

Katalyst Healthcares and Lifesciences

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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 7 hours ago

Oracle Argus Engineer

Spotline

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Alameda, California, USA

Contract

Senior Oracle Argus Engineer Alameda CA Onsite role Job Description: Manage implementation/upgrade/support of Oracle Argus Safety System or other Safety solutions and associated interfaces/integrationsPart of technical workstreams (Configuration/Data Migration/Reporting/Upgrade) and provide progress reports, proposals, requirements documentation, and presentations.As Oracle Argus SME, support technical issues associated with Oracle Argus Safety suite and related interfacesHelp deliver project an
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Posted 2 days ago

Clinical Systems (Veeva) Tester W/ CDMS (EDC)

Key Business Solutions, Inc.

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Remote

Third Party, Contract

Clinical Systems (Veeva) Tester W/ CDMS (EDC) Remote 12 Months Consultant should be work in offshore(India timings) We are looking for a well-rounded Clinical Systems Tester with core expertise in Veeva CDMS (EDC) and strong hands-on experience with eCOA and IRT platforms. This role supports testing and validation activities within a Decentralized Clinical Trial (DCT) environment, requiring flexibility across various digital systems and patient-facing technologies. Key Responsibilities: Author a
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Posted 3 days ago

Veeva Presales Consultant

NexInfo Solutions, Inc.

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Remote

Contract

Title: Veeva Presales ConsultantLocation: Remote Client Engagement & SolutioningEngage with potential clients to understand their business challenges, current system landscape, and digital transformation needs.Lead discovery sessions to gather functional and technical requirements relevant to Veeva Vault solutions (e.g., Veeva CRM, Vault Quality Docs, RIM, eTMF, PromoMats, etc.).Articulate the value proposition of Veeva products and services in the context of customer-specific use cases.Content
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Posted 18 days ago | Updated 1 day ago

Veeva Promo Mats Technical Architect-W2

Narvee Tech Inc

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Remote

Contract

Job Title: Veeva Promo Mats Technical Architect Duration: 12 Months (Possible Extension) Location: Remote/Hybrid Client Note: Minimum 2-3 end-to-end implementation required on Promo Mats.We are looking who have extensive experience in PROMOMATS. Only ask those who are hands-on with the projects who can describe the details of the project. Need Promo Mats expertiseJob Description Join IBM's Veeva Practice team as an Architect & Engineer for Veeva Commercial Cloud, where you will be a key leader i
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Posted 4 days ago

Veeva PromoMats Technical Architect - W2

Narvee Tech Inc

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Remote

Contract

Job Title: Veeva PromoMats Technical Architect Duration: 12 Months (Possible Extension) Location: Remote/Hybrid Client Note: Minimum 2-3 end-to-end implementation required on PromoMats.We are looking who have extensive experience in PROMOMATS. Only ask those who are hands-on with the projects who can describe the details of the project. Need PromoMats expertise Job Description Join IBM's Veeva Practice team as an Architect & Engineer for Veeva Commercial Cloud, where you will be a key leader in
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Posted 5 days ago | Updated 2 days ago

Lead Engineer - MES Opcenter

Katalyst Healthcares and Lifesciences

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Remote or New York, USA

Full-time

Job Description: The Lead Engineer will lead a team of technical resources to design, develop, configure, and test MES (Manufacturing Execution Systems) solutions. They will be directly responsible for leading resources contracted vi third-party and through other Pharmaceutical organizations to develop & deploy MES application software to Medical Device manufacturing sites globally. Responsibilities: Act as subject matter expert on system design and architecture. Solutioning and designing new
Posted 18 days ago | Updated 7 hours ago

Computer System Validation Analyst - R Studio & Clinical Systems

Katalyst Healthcares and Lifesciences

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Remote or New Jersey, USA

Full-time

Responsibilities: Lead validation planning, risk assessment, and execution for R Studio, GitLab, and Medidata Rave EDC. Develop and execute validation documentation including: Validation Plans (VP.). User Requirements Specifications (URS.). Risk Assessments (RA.). Functional and Design Specifications. Traceability Matrix (RTM.). Test Protocols (IQ/OQ/PQ or CSA-based scripts.). Validation Summary Reports (VSR.). Collaborate with cross-functional stakeholders including Clinical Data Mana
Posted 60+ days ago | Updated 7 hours ago

CSV/ CSA Engineer

Katalyst Healthcares and Lifesciences

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San Francisco, California, USA

Full-time

Job Description: The CSA Engineer will be responsible for ensuring that all computer systems, software applications, and related processes comply with industry standards and regulatory requirements, especially in regulated environments such as pharmaceutical, biotech, and healthcare sectors. Responsibilities: 10 Plus Years of experience in Computer System Assurance (CSA) or Computer System Validation (CSV) in regulated industries such as pharmaceuticals, medical devices, or biotechnology. Stron
Posted 60+ days ago | Updated 7 hours ago

Veeva CRM Technical Architect

Intake IT Solutions

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Remote

Full-time, Third Party

Job Title: Veeva CRM Technical ArchitectLocation: Alameda, CA (Fully remote)Duration: Long term contract/ Full time Educational Qualification*Bachelor s or Master s degree in Computer Science, Information Technology, Engineering, or a related technical field. Additional certifications in Salesforce, Veeva CRM/Align are highly preferred.Job Description of Role* (RNR) (Mandatory - Minimum 500 words)Job Summary: We are seeking an experienced Veeva CRM Consultant with a strong background in Salesfor
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Posted 3 days ago

Sr. Validation Engineer (CSV)

Katalyst Healthcares and Lifesciences

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California, USA

Full-time

Responsibilities: Create and execute Computer System Validation (CSV) deliverables (Validation Plans, Protocols, Reports, Trace Matrices, SOPs). Collaborate with Business Users, System Owners, IT teams, and Analysts to define validation requirements. Provide leadership and training in validation activities. Generate IQ/OQ/PQ protocols using Good Documentation Practices (GDP). Ensure compliance with quality system elements for computer systems/software testing. Perform gap assessments and remedia
Posted 60+ days ago | Updated 7 hours ago

Director Contract Research Organization (CRO) SME (Customer Success)

Saama Technologies, LLC

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Remote

Full-time

Director Contract Research Organization (CRO) SME (Customer Success)Location: RemoteDepartment: Customer Success Role OverviewWe are seeking a Director level Contract Research Organization (SME) with deep expertise in Clinical Data Management (CDM) and a modern understanding of clinical data workflows and analytics. This individual will play a critical dual role in ensuring delivery excellence across customer engagements and supporting strategic sales and pre-sales efforts. This is a highly visi
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Posted 1 day ago

Veeva Promomats Technical Lead - 100% remote

MSquare Systems Inc.

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Remote

Contract, Third Party

We are seeking a seasoned Veeva PromoMats Technical Lead to oversee a high-impact migration project within the life sciences domain, transitioning digital content, metadata, and workflows from legacy systems or DAM platforms into Veeva Vault PromoMats. This role is responsible for leading the technical design, validation, and execution of the migration while ensuring regulatory compliance, content integrity, and operational continuity for commercial and medical review teams. Key Responsibilities
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Posted 45 days ago | Updated 1 day ago

LIMS and QC Applications Consultant

Expedite Technology Solutions

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Remote or Bridgewater, New Jersey, USA

Full-time, Contract

Solution Architecture and Design: Lead the design and development of LabVantage LIMS solutions tailored to business and laboratory needs. Develop system workflows, configurations, and integrations with other enterprise systems (e.g., S4 Hana ERP, MES, ELN, SDMS). Define data models, interface designs, and system configurations. Implementation and Deployment: Oversee installation, configuration, and validation of LabVantage LIMS applications. Develop and execute project plans, ensuring timely an
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Posted 60+ days ago | Updated moments ago

Sr Engineer - Software

ACL Digital

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Thousand Oaks, California, USA

Full-time

Exact Schedule - fully onsite thousand oaks 8am-5pm M-F, OT possible Job Responsibilities include: 1) Developing process control applications utilizing Programmable Logic Controllers (PLC), Distributed Control Systems (DCS), Human Machine Interfaces (HMI) and Supervisory Control and Data Acquisition systems (SCADA). 2) Support projects focused on improving process equipment/utilities/facilities -to- sophisticated unit operation skids to integrate new drug product manufacturing technologies into
Posted 33 days ago | Updated 7 hours ago