21 cfr part 11 Jobs in minneapolis, mn

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Senior Full Stack Engineer (.NET 8 / Angular / Azure)-- Minneapolis, MN- Hybrid (3 days in Office + 2 days from WFH)-Medical Device exp. is must

cyberThink, Inc.

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Minneapolis, Minnesota, USA

Third Party, Contract

About the Role: We are looking for a Senior Full Stack Engineer with proven experience in modern web development using Angular (v14+), .NET 8, and Cosmos DB with Azure cloud ecosystems. You will be working on a connected medical device platform that collects therapy data and transmits it to an Azure-based cloud portal. This platform plays a vital role in improving patient care and helping clinicians and administrative teams manage healthcare delivery more effectively. This role is ideal for some
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Posted 14 days ago | Updated 14 days ago

Lead Engineer MES OpCenter

New York Technology Partners

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Remote

Contract

Job Title: Lead Engineer MES OpCenter Location: 100% Remote Experience: 12+ Years JD: Lead Engineer MES OpCenter 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 responsibility for leading resources contracted via a third-party and through other J&J organizations to develop & deploy MES application software to Medical Device manufacturing sites globally. The Lead Engineer will b
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Posted 19 days ago

Sr. Systems Analyst - Remote

VIVA USA INC

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Remote

Contract

Title: Sr. Systems Analyst - Remote Mandatory skills: DOORS Next Gen, ETM, DNG, Engineering Test Management, DOORS Classic, Admin, Project Management, IBM Rationale SaaS systems, IBM systems, medical device product development, medical devices computer systems validation, 21 CFR Part 11 requirement, application systems requirements, application system specifications, application solutions, maintenance, production support, conceptual system requirements, job flows, program specifications, system
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Posted 28 days ago | Updated 3 days ago

Full Stack Developer

Stefanini

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Minneapolis, Minnesota, USA

Contract

Stefanini Group is looking for Sr Full Stack Developer for a globally recognized company! For interested applicants, click the apply button or you may reach out to Alfher Hidalgo at / for faster processing. Thank you! About the Role: We are looking for a Senior Full Stack Engineer with proven experience in modern web development using Angular (v14+), .NET 8, and Cosmos DB with Azure cloud ecosystems. You will be working on a connected medical device platform that collects therapy data and transm
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Posted 20 days ago | Updated 9 hours ago

CSV Engineer

Katalyst Healthcares and Lifesciences

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Maple Grove, Minnesota, USA

Full-time

Responsibilities: To ensure the quality of our client's software applications and equipment by validating/qualifying to specifications. Provide comprehensive documentation (specifications and validation/qualifications) per the division's policy to meet FDA regulations. Define the development of comprehensive specifications (hardware and/or software) for equipment/software from basic functionality to complex systems such as PLC's, Visual Basic applications, databases, SCAD pplications, and system
Posted 47 days ago | Updated 1 hour ago

Software Quality Engineer III

Boston Scientific Corporation

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Maple Grove, Minnesota, USA

Full-time

Additional Location(s): N/A Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance At Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we'll help you in advancing your skills and career. Here, you'll be supported in progressing - whatever your
Posted 60+ days ago | Updated 1 hour 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 12 hours ago | Updated 9 hours ago

Veeva Presales

NexInfo Solutions, Inc.

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Remote

Third Party, Contract

Role: Veeva Presales 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 Creation & RFP Manage
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Posted 12 hours ago | Updated 12 hours ago

DOORS Administrator (W2 Only)

Generis TEK Inc.

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Remote

Contract

We have Contract role DOORS Administrator (W2 Only) for our client at Sylmar CA. Please let me know if you or any of your friends would be interested in this position. Position Details: DOORS Administrator (W2 Only)-REMOTE-Sylmar CA Location : REMOTE Project Duration : 12+ Months Contract with potential to extend Pay Rate : $65/hr. on W2 Job Description: Responsible for configuration of IBM Rationale SaaS systems, specifically DOORS Next Gen (DNG) and Engineering Test Management (ETM). - Must ha
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Posted 4 days ago | Updated 4 hours ago

Manual QA with healthcare experience

Techsunsoft

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Remote

Contract

Title - Manual QA with healthcare experience Location: Remote Work Type: W2 Contract Start Date: ASAP Job Description:We are looking for a Senior QA Engineer with deep expertise in healthcare processes and AI driven applications. This role is critical in ensuring the safety, accuracy, and compliance of our healthcare-focused AI products. The ideal candidate will have a strong background in QA methodologies (both manual and automated testing, building test cases, writing test plans, etc.), exper
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Posted 1 day 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 1 hour 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 47 days ago | Updated 1 hour ago

Lead Engineer MES Opcenter

Zettalogix INC

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Remote

Contract, Third Party

Position: Lead Engineer MES Opcenter RemoteDuration: 6 months with opportunity for extension or conversion Job Description:Lead Engineer MES OpCenter 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 via a third-party and through other client organizations to develop & deploy MES application software to Medical Device manufacturing s
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Posted 4 days 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 27 days ago | Updated 13 days ago

MES Consultant

BOTG LLC

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Remote

Full-time

Location: Remote Job Type: Full-Time / Contract Industry: Life Sciences / Pharmaceuticals / Manufacturing About the Role: We are seeking experienced MES (Manufacturing Execution System) Consultants with strong backgrounds in Electronic Batch Records (EBR) and Master Batch Record (MBR) design, along with hands-on recipe authoring experience. This is a remote position, ideal for professionals with a solid understanding of GMP-regulated environments, especially in pharmaceutical or biotech manufact
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Posted 56 days ago | Updated 19 days 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 8 hours ago

Sr. Manager, SAP CGTO Solutions Architect

Gilead Sciences, Inc.

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Remote or Santa Monica, California, USA

Full-time

At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead's team plays a critical ro
Posted 25 days ago | Updated 1 hour ago

IBM Maximo EAM Specialist

NTT DATA Americas, Inc

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Remote or Greenville, North Carolina, USA

Contract

IBM Maximo EAM Specialist - 25-05059 100% Remote 6+ Mths Duration W2 or C2C NTT DATA's Client is seeking an IBM Maximo EAM Specialist with15 years of experience validating Maximo systems under 21 CFR part 11 compliance under GMP practices and 2 years successful deployment of MAS 8.X and 9.X in validated Life Science Industry 15 years of experience in EAM including implementation, system installation, customization, configuration, upgrades, patch management, integration and data migration Experi
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Posted 28 days ago | Updated 8 hours ago

Senior CQV Engineer

Johnson & Johnson

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Remote or Athens, Georgia, USA

Full-time

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn m
Posted 49 days ago | Updated 1 hour ago

Manager, Software Development

Fresenius Medical Care

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Remote or Concord, California, USA

Full-time

Manager, Software Development, Fresenius USA, Inc., a Fresenius Medical Care N.A. company, Martinez, California (Hybrid) Responsible for directing software systems development, software application development, and software quality assurance for software enhancements and new products including cloud-based and/or internet-related tools. Will manage a team of software developers to design, code, test, and implement high quality software for dialysis and related products. Will also be responsible
Posted 9 days ago | Updated 1 hour ago