21 CFR Part 11 jobs

Project Manager/ Business Analyst (Clinical Operations)

Hybrid in Foster City, California

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6d 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

GxP Project Manager (Pharma)

Hybrid in San Francisco, California

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13d 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

Computer System Validation (CSV) in life sciences

Remote

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3d ago

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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Contract, Third Party

45 - 50

Loftware Spectrum Technical Lead

Remote

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3d ago

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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Third Party, Contract

Depends on Experience

Business Systems Support Analyst

Laguna Beach, California

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12d ago

HonorVet Technologiesis a Service Disable Veteran-Owned IT staffing firm, ISO 9001, and ISO 27001 certified, working with federal agencies, state governments, and Fortune 500 enterprise clients across the US. What makes us different isn't a tagline; it's the way we work. We don't forward resumes and hope for the best. We take the time to understand where a professional like you are headed and only reach out when we genuinely believe there's a fit worth exploring. I came across your profile, and

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Contract

$26 - $33.85

Validation Analyst

Hybrid in San Francisco, California

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5d ago

Job Title: Validation AnalystProject: Medical Imaging & Algorithm Workbench Location: San Francisco, CA Work Model: Hybrid 4 Days Onsite Role OverviewWe are seeking an experienced Validation Analyst to support Roches GIP program, focusing on the validation of medical imaging applications, AI/ML workflows, and the Algorithm Workbench platform. The ideal candidate will ensure system quality, regulatory compliance, data integrity, and end-to-end validation readiness while supporting software rele

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Contract, Third Party

70 - 80

Computer Systems Validation Engineer

Boston, Massachusetts

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Today

Are You Ready? CAI is a professional services company established in 1996 that has grown to more than 700 people worldwide. We provide commissioning, qualification, validation, startup, project management, and other consulting services associated with operational readiness to FDA-regulated and other mission-critical industries. Our approach is simple-we put the client's interests first, we don't stop until it's right, and we do whatever it takes to get there. Our Foundational Principles: - W

Full-time

USD 75,000.00 - 106,000.00 per year

Systems Engineering Specialist

Boulder, Colorado

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Yesterday

Payrate: $54.79 - $54.79/hr Summary: As an Advanced/OT Operation & Infrastructure Professional, you will serve as the first point of contact for the Boulder site regarding any IT equipment or IT system related issues. You will collaborate with suppliers and global teams to resolve these issues efficiently. Additionally, you will be responsible for managing IT-related compliance needs and documentation for projects, ensuring all requirements are met and maintained. Responsibilities:Manage and Ma

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Contract

$54.79 - $54.79

Loftware Spectrum Technical Lead / Solution Engineer

Remote

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14d 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

Digital Eng, Robotics & Automation, Process Sciences, Analytics and Technology, CGT

Los Angeles, California

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Today

We are seeking a Engineer, Digital and Data Science - Robotics and Automation within Process Sciences, Analytics and Technology, Cell and Gene Therapy. This engineer role will execute software, data, systems-integration, and digital-connectivity work required to develop and operate advanced robotic and automation platforms supporting AZD0120 and future cell and gene therapy programs. This engineer will build and support reliable interfaces, reusable software components, data pipelines, workflow

Full-time

USD 90,024.00 - 135,036.00 per year

CQV Engineer

Atlanta, Georgia

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18d ago

Summary: Seeking a CQV Validation Engineer with 5+ years of experience in pharmaceutical, biotech, or life sciences. The ideal candidate will have hands-on experience with Commissioning, Qualification & Validation (CQV) for standalone manufacturing equipment in a GMP-regulated environment. Roles & Responsibilities: Perform CQV activities for standalone equipment. uthor and execute IQ/OQ/PQ protocols, validation plans, and reports. Support FAT, SAT, commissioning, qualification, and validat

Full-time

CSV Validation Engineer

Jacksonville, Florida

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18d ago

Summary: We are currently looking for an experienced CSV (Computer System Validation) Engineer to join our team in Plymouth, MN. Roles & Responsibilities: Develop and execute Computer System Validation (CSV) strategies, plans, protocols, and reports. Create and maintain validation documentation including URS, FS, DS, IQ, OQ, PQ, and validation summary reports. Perform risk assessments, impact assessments, traceability, and change control activities. Support validation of GxP-regulated computeri

Full-time

CSV Validation Engineer

Plymouth, Minnesota

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18d ago

Full-time

Sr. Computer Systems Validation Analyst

Foster City, California

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18d 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

Sr. Computer Systems Validation Analyst

Foster, California

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18d ago

Full-time

SAP Validation

Remote

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27d 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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Today

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

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

CSV Engineer

Plainfield, New Jersey

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Today

Job Title: CSV Validation Consultant - Pharma Location: Plainfield,NJ (Hybrid) Experience: 10 years Job Description: Experience in Computer System Validation (CSV) within the Pharmaceutical/Life Sciences industry. Strong knowledge of GxP, FDA 21 CFR Part 11, GAMP 5, and data integrity requirements. Experience preparing/reviewing URS, FRS, Risk Assessments, IQ/OQ/PQ, Validation Plans and Reports. Hands-on experience with validation of GxP computerized systems and related documentation. Knowledg

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Full-time, Part-time, Contract, Third Party

CQV Engineer

Portland, Maine

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18d ago

Summary: Seeking a CQV Validation Engineer with 5+ years of experience in pharmaceutical, biotech, or life sciences. The ideal candidate will have hands-on experience with Commissioning, Qualification & Validation (CQV) for standalone manufacturing equipment in a GMP-regulated environment. Roles & Responsibilities: Perform CQV activities for standalone equipment. Author and execute IQ/OQ/PQ protocols, validation plans, and reports. Support FAT, SAT, commissioning, qualification, and val

Full-time