21 CFR Part 11 jobs in California

Computer System Validation (CSV) Engineer

Vacaville, California

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Today

Computer System Validation Location: Vacaville CA (Onsite Role) Duration: - 6 -12 Months+ Job Requirements As a Computer System Validation (CSV) Engineer specializing in the pharmaceutical industry, you will ensure that computer-based systems such as Manufacturing Execution Systems (MES), process control software, and automation platforms comply with GxP, FDA 21 CFR Part 11, EU Annex 11, and other applicable regulations. Key Responsibilities: Develop, execute, and review validation deliverable

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Contract

Depends on Experience

CSV Engineer

San Francisco, California

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Today

Summary: We are looking for a skilled CSV Engineer with strong experience in Veeva systems to support validation, compliance, and implementation activities in a regulated life sciences environment. The ideal candidate will have hands-on experience working on Veeva platforms and ensuring systems meet GxP and 21 CFR Part 11 compliance. Roles & Responsibilities : Perform Computer System Validation (CSV) activities for Veeva applications. Develop and execute validation documents: URS, FRS, IQ, OQ,

Full-time

CSV Engineer

San Francisco, California

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Today

Job Title: CSV Engineer Location: San Francisco Bay Area, CA (Onsite 4 days/week) Experience: 5+ years Job Description (Short JD) Lead Computer System Validation (CSV) activities for Medidata CTMS and other clinical applications. Author and execute validation deliverables including URS, FRS, Risk Assessments, Validation Plan, IQ/OQ/PQ scripts, Traceability Matrix, and Summary Reports. Ensure compliance with 21 CFR Part 11, GAMP 5, GxP, and internal QA procedures. Work independently with c

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Contract

CSV Engineer

Costa Mesa, California

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Today

Roles & Responsibilities: Bachelor's degree in engineering, Computer Science, Life Sciences, or related field. 2-10+ years of experience in computerized systems validation within pharmaceutical, biotechnology, or life sciences industries. Direct experience with GxP equipment, IT systems, or manufacturing automation systems. FDA and cGMP regulations and documentation practices. GAMP 5 guidance. 21 CFR Part 11 and Annex 11. Computer system validation methodologies. Familiarity with risk-based

Full-time

Validation Engineer - GxP Systems

San Francisco, California

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Today

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 documen

Full-time

Kneat System Developer (Technical & Validation Focus)

Remote or Parsippany-Troy Hills, New Jersey

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3d ago

Job Title: Kneat System Developer (Technical & Validation Focus) Location Remote/WFH Duration: 6 months+ contract Note: Need strong Kneat Development / Configuration and not a user of Kneat. Overview of the Project: You will be configuring Kneat workflows and interacting with business stakeholders. Key Responsibilities: Develop, configure, and maintain Kneat GxP Validation software. Create and manage disciplines and templates. Ensure system validation and compliance with GxP, 21 CFR Part 11,

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Contract, Third Party

SAP Security Architect- Remote , CA (W2 Only)

Remote

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5d ago

Job Tile: SAP Security Architect location: Remote Duration: 6 Months Key Responsibilities: Lead SAP Security strategy and execution across S/4HANA and integrated systems (Fiori, GRC, Ariba, BTP, SAC, etc.).Review and recommend security architecture solutions aligned with business and compliance needs.Manage and mentor a team of SAP security analysts and consultants.Conduct security workshops and drive role design, provisioning, and governance.Collaborate with IT, audit, and business stakeholde

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Contract

Depends on Experience

Veeva Migration Consultant

Remote

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24d ago

We have a below position for Veeva Migration expert for remote work, please find the JD below and let me know your interest. Title: Veeva Migration Consultant Exp: 7+ to 10 years of experience in Veeva migration and implementation activities Duration: 6-12 Months Responsibilities: Migration Work stream Lead-Veeva RIMS Implementation Key Responsibilities Migration Strategy & PlanningDefine migration scope, timelines, resources, and success metrics.Develop detailed migration plans and risk mitiga

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Third Party, Contract

Depends on Experience

Sr. CSV Engineer

Oregon City, California

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Today

Summary : Responsible for preparing and executing test documentation for GMP computerized systems as well as providing support in the troubleshooting of issues during test execution. You should have excellent understanding of 21 CFR Part 11, ICH standards, EMA and FDA (GxP) regulations, and GAMP methodologies. Coordinate with multi-disciplinary validation team and be responsible for the validation of automated equipment and control systems Create and modify validation documentation including but

Full-time

LabVantage LIMS Configurator

Remote

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Today

RAYVEN IT Solutions is a leading IT Consulting firm offers a comprehensive range of services that are domain specific with a strong focus on technology, business process & practices. Founded by top-notch profs with the vision of bridging the gap between people, process & technology. RAYVEN has the capability & resources to help clients realize their technology driven business transformation initiatives. We are specialized & provide solution-based services to our clients in the areas of SAP/ERP.

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Third Party, Contract

Depends on Experience

Clinical eTMF Consultant

Remote or Massachusetts

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Today

Job Title: Clinical eTMF Consultant Department: Clinical Operations Position Summary: The Clinical eTMF Specialist is responsible for managing and maintaining the Electronic Trial Master File (eTMF) system to ensure compliance with regulatory requirements, internal quality standards, and study timelines. This role ensures that all clinical trial documentation is complete, accurate, and inspection-ready at all times. The eTMF Specialist serves as a key liaison between Clinical Operations, Qual

Third Party, Contract

Statistical Software Configuration Specialist (Statistica TIBCO)

Remote or Hybrid in Vacaville, California

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Today

Statistical Software Configuration Specialist (Statistica TIBCO) Vacaville, CA / A hybrid model (once or twice in the office) / Remote Duration: - 6-12 Months+ For a "Statistica Software configuration specialist" role, which likely involves both data analytics and potentially on-site manufacturing support or collaboration, a hybrid model (once or twice in the office) is a probable arrangement. Statistical Software Configuration Specialist (Statistica TIBCO) Position Overview The Statistical Soft

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Contract, Third Party

Depends on Experience

COTS Support Engineer withLife Sciences domain

Foster City, California

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Today

Title: COTS Support Engineer with **Life Sciences domain**. Location: Onsite to Fosters City Minimum 6+ years of experience supporting commercial off-the-shelf (COTS), The ideal candidate will have a strong foundation in application support and a keen interest in expanding their expertise across new COTS platforms used in pharmaceutical, biotech, or clinical research environments. Good experience with Lorenz (Submission Publishing System), GFAP, and supporting systems/software. Experience Range

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Contract, Third Party

$70+

Systems Administrator / Technical Lead – Process Control Systems

Foster City, California

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25d ago

We are looking for an experienced professional who will be responsible for administration of Rockwell FactoryTalk-based process control systems and Inductive Automation's Ignition-based process control and environmental monitoring systems. The candidate should have hands-on experience deploying, configuring, and troubleshooting these systems in a Good Manufacturing Practice (GMP) environment, with a good understanding of FDA regulations. This role focuses on deploying system updates, administeri

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Contract

65 - 70

Veeva Vault Consultant

San Francisco, California

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4d ago

About Nexinfo: NexInfo is a consulting firm focused on improving business processes and automation in the Supply Chain and Product Lifecycle Management sectors.They offer services in business process design, software implementations, managed services, staff augmentation, and SaaS solutions. The company aims to help businesses across industries achieve their goals through industry best practices, lean process design, and advanced software solutions. Their ERP-related services address challenges

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Contract, Third Party

70 - 80

CSV and Validation Engineer

Remote or New Jersey

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Today

Job Description: We are seeking a hands-on CSV and Validation Engineer to validate software used with laboratory instruments and lab informatics platforms. The role owns risk-based validation planning and execution aligned to EMA Annex 11 and 21 CFR Part 11, authors audit-ready documentation, and partners with QA/IT/Lab to transition systems to standardized SOPs. Responsibilities: Plan and execute computer system validation using a risk-based CSA approach aligned to GAMP 5. Validate instrument

Full-time

Data Architect(Dicom/Medical Imaging)

San Francisco, California

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4d ago

Who we are: - At CitiusTech, we constantly strive to solve the industry's greatest challenges with technology, creativity, and agility. With over 8,500 healthcare technology professionals worldwide, CitiusTech powers healthcare digital innovation, business transformation, and industry-wide convergence for over 140 organizations through next-generation technologies, solutions, and products. We aim to accelerate the transition to a human-first, sustainable, and digital healthcare ecosystem with th

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Full-time

$200,000 - $220,000

Validation Engineer II

Santa Clara, California

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Today

Work Schedule Standard Office Hours (40/wk) Environmental Conditions Able to lift 40 lbs. without assistance, 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 As a Validation Engineer II, you will support validation and qualification activities for TruBio software and bioprocessing equipment. You will write and execute validation

Full-time

USD 72,000.00 - 108,000.00 per year

Director - Lab Informatics

Remote

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Today

Position Summary: The Director of Lab Informatics is responsible for developing and executing a comprehensive informatics strategy to support laboratory operations across multiple functional areas including analytical development, quality control (QC), and manufacturing science and technology (MSAT). The role will drive innovation and digital transformation by integrating advanced informatics platforms that enhance data integrity, increase operational efficiency, and ensure regulatory complianc

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Contract, Third Party

Staff Validation Engineer

Santa Clara, California

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Today

Work Schedule Standard (Mon-Fri) Environmental Conditions Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Laboratory Setting, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Working at heights Job Description As a Staff Validation Engineer, you will play a key role in ensuring our bioprocessing equipment and TruBio software systems meet the highest st

Full-time

USD 112,500.00 - 187,500.00 per year

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21 CFR Part 11 jobs in California, USA