21 CFR Part 11 jobs

Hybrid in San Francisco, California

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21d 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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Third Party, Contract

$80 - $90

Senior Software Validation with Medical Device and IEC and ISO Exp

Remote

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4d ago

JOB DESCRIPTION: We are seeking a Senior Software Validation & Quality Engineer with experience in regulated environments, preferably medical devices. The ideal candidate will support software quality, validation, testing, compliance, and audit readiness. Key Responsibilities: Review software requirements, design documents, test plans, validation protocols, and reports.Support software V&V, functional/integration/system testing, and validation activities.Maintain requirements traceability (RTM)

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Contract

$30 - $40

Low-Code/No-Code MES Developer

Hybrid in Indianapolis, Indiana

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5d ago

Low-Code/No-Code MES Developer Location: Hybrid, Indianapolis, IN Responsibilities Design, develop, configure, test, and deploy Apprentice Tempo procedures, workflows, master batch records, digital logbooks, and digital forms, personally, not just from a requirements documentBuild and deploy low code/no code applications (Apprentice Tempo, PowerApps/Power Automate, or comparable) supporting manufacturing, quality, warehouse, and supply chain workflows, e.g. cycle counts, receiving, inventory adj

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Contract

Depends on Experience

MES Business Analyst

Hybrid in Indianapolis, Indiana

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5d ago

MES Business Analyst Location: Hybrid, Indianapolis, IN Responsibilities Elicit and document business, functional, and non functional requirements from shop floor, manufacturing, quality, warehouse, and supply chain stakeholdersTranslate business and shop floor requirements into functional solution designs, balancing usability, compliance, and maintainabilityDevelop process maps (as is / to be), user stories, data mapping specifications, and acceptance criteriaPerform fit gap analysis between ma

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Contract

Depends on Experience

Manufacturing Data Strategy & Architecture Consultant

Remote

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15d 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

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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19d 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

Sr. Manager, Interactive Response Technology

Novato, California

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5d ago

Description: (remote) The Client is engaging a hands-on Interactive Response Technology (IRT) Lead to own the design, build, implementation, and lifecycle management of IRT/RTSM (randomization and trial supply management) systems across Phase IIV clinical trials, including the integrations that connect them to adjacent clinical and enterprise platforms. This is an individual contributor engagement: the person in this seat does the work, rather than directing a team that does it. The role sits

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Contract, Third Party

$65 - $75

Clinical Data Business Analyst

Alameda, California

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4d ago

Clinical Data Business Analyst Biometrics & Data Engineering Role Overview This role is the connective tissue between Biometrics and Data Engineering. It exists because clinical data has meaning that structure alone doesn t carry: someone has to understand what the data represents clinically, what the standards require of it, and how it must therefore be modeled and then make sure the engineering team builds systems that produce it correctly. The SME owns that translation. They bring clinical

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Contract, Third Party

CQV Engineer

Atlanta, Georgia

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17d 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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17d 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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17d 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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17d 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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17d 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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17d ago

Full-time

SAP Validation

Remote

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6d 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

MES Techno-Functional Consultant with pharma/life sciences domain.-Parsippany, NJ

Parsippany-Troy Hills, New Jersey

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Today

This is a senior techno-functional manufacturing integration role in the pharma/life sciences domain. The person will lead OT/IT and MES integration, translate business requirements into technical solutions, manage technical designs, risks, UAT, and cross-functional stakeholders. Key expertise includes OEE, Connected Worker, Golden Batch, MES/PAS-X, MDF, GxP/CSV, FDA 21 CFR Part 11, and manufacturing data flows. SAFe, ISA-95/ISA-88, and UNS are preferred.

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Contract

Depends on Experience

Sr Technical Writer

Remote

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Today

Hi, Hope you are doing well. Job Title: Sr IT Technical Writer Location: Remote Duration:12+ Months Job Description: We areseeking a Senior IT Technical Writer with 10+ years of experience to support technical documentation initiatives within a Bio-Pharma/Life Sciences environment. The consultant will work closely with IT, engineering, application, infrastructure, quality, validation, and business teams to develop accurate and compliant documentation for regulated systems. The role involves cr

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Contract

Depends on Experience

IT Lab Support

Cambridge, Massachusetts

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3d ago

IT GxP Lab Computing Engineer The Lab Computing Engineer provides both consulting, analytical and technical laboratory services, including multivendor instrument, information technology as well as in-lab validation/compliance services when applicable. The individual will provide the consulting skills required to analyze customer needs and gaps to propose solutions for the desired state. He or she will work with business users and managers of customers in conjunction with the internal support tea

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Contract

$45 - $50

Lab Support IT Administrator

Wilmington, Ohio

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12d 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