21 CFR Part 11 jobs

Hybrid in San Francisco, California

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14d 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

OCM Consultant - MDM

Hybrid in Fort Worth, Texas

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12d ago

Title: Organizational Change Management Consultant - MDM Location: Fort Worth, TX (Hybrid- 3days onsite in a week) Position Overview TheOCM Leadwill drive the people, process, and culture strategy for our globalMaster Data Management (MDM)transformation. In the highly regulated medical device industry, data integrity directly impacts product quality, regulatory compliance, and patient safety. This role focuses on accelerating the adoption of new data governance policies, standardized workflows,

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Contract, Third Party

Depends on Experience

Bioinformatics Pipeline Engineer

Remote

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2d ago

Bioinformatics Pipeline Engineer (3+ Years Exp) REMOTE We are looking to hire a candidate with the skills sets mentioned and experience for one of our clients within the life science Industry. Job Summary: We are seeking a 3+ years experience candidate with a experience in Next-Generation Sequencing (NGS) pipelines and bioinformatics workflows. The ideal candidate should have exposure to Illumina sequencing data, secondary analysis pipelines and workflow tools like Nextflow. This role focuses o

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Contract

50 - 55

IT Business System Analyst I # 26-23641

Hollywood, Florida

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11d ago

Duration: 14 months with possible extension Overview The IT Support Analyst will support local IT applications and serve as a key connection between IT and business operations within a pharmaceutical environment. This role will help manage applications, support validation activities, translate business needs into practical technical solutions, and collaborate with local and global teams to improve efficiency while meeting quality and regulatory requirements. Responsibilities Application Support

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Contract

$42 - $44

-Sr QMS Developer

Sunnyvale, California

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3d ago

Actual Title of the role: Sr QMS Developer Duration: 1 Year Contract/possibility for conversions: Contract Onsite/Hybrid/Remote: Hybrid (3 days) Only Locals/Nonlocals can be submitted: Locals only Mode of interview: Virtual/In-person No of rounds of interview: 2 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 (

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Third Party, Contract

$88 - $88

Manufacturing Data Strategy & Architecture Consultant

Remote

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8d ago

Job title: Manufacturing Data Strategy & Architecture Consultant Location: Remote Position Overview Seeking a senior Manufacturing Data Strategy & Architecture Consultant to support the development of a future-state data vision, strategy, and architecture roadmap. The ideal candidate will bring deep expertise in pharmaceutical manufacturing data ecosystems, industrial data architectures, contextualization, semantics, and GxP-regulated environments. This role will serve as a trusted advisor to Pf

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Full-time, Third Party

Depends on Experience

Sr. IT Project Manager

Remote

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Today

We are seeking a Senior IT Project Manager with demonstrated experience leading complex, cross-functional technology initiatives in global and regulated manufacturing environments. The immediate priority for this role will be the delivery of projects involving Manufacturing Execution Systems, with a primary focus on the Critical Manufacturing MES platform. The successful candidate should also bring experience that can be applied across adjacent enterprise technology domains, such as SAP/ERP,

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Contract

60 - 65

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

DeltaV Automation Engineer (Biotech/Pharmaceutical)

Raleigh, North Carolina

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11d ago

Title: DeltaV Automation Engineer (Biotech/Pharmaceutical) Location - Raleigh - Durham NC Various years of experience: 3 - 7 years /7 - 14 years/14+ years Candidates need to be local or willing to relocate to the areas of operation where we have open opportunities for immediate hire in the Raleigh - Durham NC area: Mandatory Skills: 3+ years of work experience with Emerson DeltaV 3+ years of work experience with DeltaV Responsibilities Design, configuration, integration and implementation of pr

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

Clinical Database Specialist (eCRF Design)

Remote or Texas

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Today

McKesson is an impact-driven, Fortune 10 company that touches virtually every aspect of healthcare. We are known for delivering insights, products, and services that make quality care more accessible and affordable. Here, we focus on the health, happiness, and well-being of you and those we serve - we care. What you do at McKesson matters. We foster a culture where you can grow, make an impact, and are empowered to bring new ideas. Together, we thrive as we shape the future of health for patien

Full-time

USD 90,600.00 - 151,000.00 per year

CQV Engineer

Atlanta, Georgia

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10d 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

CQV Engineer

Portland, Maine

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10d 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

CQV Engineer

Concord, North Carolina

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10d 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 valid

Full-time

CSV Validation Engineer

Plymouth, Minnesota

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10d 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 compu

Full-time

Sr. Computer Systems Validation Analyst

Foster, California

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10d 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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10d ago

Full-time

CSV Lead Consultant at Princeton, NJ (Hybrid, 3 days in Office) || W2 Only

Hybrid in New Jersey

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Today

CSV Lead Consultant Princeton, NJ (Hybrid, 3 days in Office) Long Term Contract Mandatory Skills- Computer System Validation (CSV), GxP Systems & Compliance, Manufacturing Domain Knowledge, Labeling Systems Knowledge, Validation Testing (IQ/OQ/PQ) , Validation Documentation , FDA 21 CFR Part 11 / GAMP5 , Risk Assessment & Change Control , Stakeholder Management , Audit & Inspection Support Role Summary We are seeking an experienced Computer System Validation (CSV) Professional with strong exper

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Contract

CSV/CSA Consultant – ValGenesis & BMRAM

Hybrid in Hopkinton, Massachusetts

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2d ago

Job Title: CSV/CSA Consultant ValGenesis & BMRAM Location: Hopkinton, MA Duration: 6+ Months Job Type: Contract Industry: Pharmaceutical / Biotechnology / Cell & Gene Therapy Job DescriptionOur client, a leading pharmaceutical/biotechnology organization, is seeking an experienced CSV/CSA Consultant to support the qualification and validation of GMP computerized systems, laboratory systems, and analytical equipment. The ideal candidate will have strong hands-on experience in Computer System Vali

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Contract

Depends on Experience

Lab Support IT Administrator

Wilmington, Ohio

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4d ago

WERE HIRING | LAB IT + GxP COMPLIANCE EXPERT Looking for an experienced Lab Support IT Administrator who can manage regulated laboratory systems while ensuring GxP compliance, data integrity. Wilmington, OH 45177 | Onsite Contract: 6+ Months Key Requirements: GxP / GMP / GLP / Google Cloud Platform Compliance CSV | FDA 21 CFR Part 11 | EU Annex 11 | GAMP 5 | ALCOA+ Windows, Active Directory & Advanced GPO Laboratory Systems & Instrument Support Cybersecurity & Vulnerability Management T

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Contract

Depends on Experience

Computer System Validation Engineer

Wilmington, Delaware

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10d ago

Roles & Responsibilities : 21 CFR Part 11/820, GxP, GAMP 5, SOX, EU Annex 11/22, ISO 9001, ITIL, EU Anness 22, ISO 9001, ITIL, Audit/inspection readiness, periodic reviews, access roster and audit trail reviews, Deviation/CAPA management, SOP/policy compliance processes uthoring of URS/FS, protocols, final reports, validation plan/report High-level understanding of Veeva Vault suits Risk-based testing aligned to CSA fundamentals High-level understanding of Biostatistics, Clinical, Discovery, Med

Full-time