21 cfr part 11 Jobs in denver, co

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IT Project Manager Lead V - LIMS - Laboratory Information Management System/ LabVantage

Javen Technologies, Inc

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Remote

Contract

Job Title: IT Project Lead V LIMS Project Manager< class="MsoNormal">Location: Remote< class="MsoNormal">Duties: < class="MsoNormal">This role will assist with the implementation of a new Laboratory Information Management System (LIMS) and Electronic Lab Notebook (ELN) to be used across the organization starting in 2026.< class="MsoNormal">Domain Knowledge:<>Experience with LIMS (Laboratory Information Management Systems) preferably LabVantage<>Understanding of clinical, research, or diagnostic
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Posted 1 day ago | Updated 1 day ago

LIMS - Laboratory Information Management Systems

Javen Technologies, Inc

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Remote

Contract, Third Party

Experience with LIMS (Laboratory Information Management Systems) preferably LabVantage Understanding of clinical, research, or diagnostic lab workflows Knowledge of regulatory requirements (GxP, FDA 21 CFR Part 11) Familiarity with lab instruments, integrations, and data flows Working with ELNs (Electronic Lab Notebooks) and lab automation Basic understanding of data security, validation, and integrity in lab system Skills: Business Analysis Skills: Requirements gathering and documentation Proce
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Posted 2 days ago | Updated 1 day ago

Validation Engineer 4

Katalyst Healthcares and Lifesciences

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Littleton, Colorado, USA

Full-time

Job Description: We are seeking a detail-oriented and experienced LabVantage Business Analyst to support the implementation, optimization, and ongoing support of LabVantage LIMS (Laboratory Information Management System). The ideal candidate will work closely with business stakeholders, scientists, QA teams, and IT to gather requirements, analyze workflows, and ensure that LabVantage solutions align with organizational needs. Responsibilities: ct as the liaison between scientific/business teams
Posted 60+ days ago | Updated 4 hours ago

Computer System Validation Lead

Nityo Infotech Corporation

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Remote

Contract, Third Party

Job Details: 7-10 years experience in Computer System Validation of EMS and BMS applications Must have experience in Agile methodology and handled multiple releases in parallel Extensive knowledge in CSV, CSV auditing, creation and revision of CSV documentation, experience with EMS/BMS, project management, test script review, test execution review, test defect management. Has working experience in any one or two of the following domains Tool validation like ServiceNOW, Automation tools, JIRA Gu
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Posted 1 day ago

Laboratory Information Management System (LIMS) /ELN Consultant, MN/REMOTE - Direct Client

Javen Technologies, Inc

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Remote

Contract, Third Party

Javen Technologies Direct Client is looking for Laboratory Information Management System (LIMS)/Electronic Lab Notebook (ELN) Consultant in Maplewood MN. 100% REMOTE opportunity. If interested, please reach me at / - Gowri. Domain Knowledge: Experience with LIMS (Laboratory Information Management Systems) preferably LabVantage Understanding of clinical, research, or diagnostic lab workflows Knowledge of regulatory requirements (GxP, FDA 21 CFR Part 11) Familiarity with lab instruments, integra
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Posted 2 days ago

Lead IT Validation Consultant

Amaze Systems Inc

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New York, USA

Contract, Third Party

Lead IT Validation Consultant Remote Notes : Prior experience in CROs, clinical research organizations, or pharmaceutical/biotech companies. Knowledge of laboratory processes such as PK, TK, and biomarker studies. Experience with integration of LIMS with other lab or enterprise systems (e.g., CDS, ELN, CTMS).Validation or QA certifications a plus. JD: We are seeking an experienced IT Validation Consultant to lead and support the validation of Laboratory Information Management System (LIMS) used
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Posted 4 days ago | Updated 1 day ago

IT Project Lead V - LIMS Project Manager

Javen Technologies, Inc

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Remote

Third Party, Contract

Job Title: IT Project Lead V Location: Remote. Duration: 15+ Months (Extendable) Duties: This role will assist with the implementation of a new Laboratory Information Management System (LIMS) and Electronic Lab Notebook (ELN) to be used across the organization starting in 2026. Domain Knowledge: Experience with LIMS (Laboratory Information Management Systems) preferably LabVantageUnderstanding of clinical, research, or diagnostic lab workflowsKnowledge of regulatory requirements (GxP, FDA 21 CFR
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Posted 2 days ago

Computer System Validation (CSV) Engineer

Katalyst Healthcares and Lifesciences

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Remote or Massachusetts, USA

Full-time

Responsibilities: Lead and execute CSV activities across GxP-regulated systems (LIMS, MES, ERP, etc. Author and maintain validation deliverables: URS, FS, DS, IQ, OQ, PQ, and traceability matrices. Ensure systems comply with 21 CFR Part 11, EU Annex 11, and GAMP 5. Support system implementations, upgrades, and periodic reviews. Collaborate with QA, IT, and business users to drive validation strategy. Participate in audits and inspections to demonstrate compliance. Requirements: Bachelor's
Posted 16 days ago | Updated 4 hours 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 26 days ago | Updated 1 day 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 60+ days ago | Updated 4 hours 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 25 days ago | Updated 4 hours ago

Aveva / OSIsoft PI Integration AWS Developer

U.S. Tech Solutions Inc.

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Remote

Contract

Location: 100% Remote Duration: 12 Months Job Description: Seeking a hand-on and experienced Senior Developer with 5+ years of experience in core AWS services. They will work with the team to design, build, and apply best practices. Key Responsibilities: The ideal candidate will have strong programming skills with extensive experience in AWS services.Design and implement back-end services using AWS lambda, Glue, Step Functions, API Gateway, S3, Aurora Postgres, Event Bridge and CloudWatch.Exper
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Posted 2 days ago

Director Contract Research Organization (CRO) SME (Customer Success)

Saama Technologies, LLC

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Remote

Full-time

Director Contract Research Organization (CRO) SME (Customer Success)Location: RemoteDepartment: Customer Success Role OverviewWe are seeking a Director level Contract Research Organization (SME) with deep expertise in Clinical Data Management (CDM) and a modern understanding of clinical data workflows and analytics. This individual will play a critical dual role in ensuring delivery excellence across customer engagements and supporting strategic sales and pre-sales efforts. This is a highly visi
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Posted 8 days ago

IT Enterprise Architect with Life Science Experience

K Source Inc

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Remote

Contract, Third Party

Hi , This is Sagar from KSource Inc. We have an excellent job opportunity for you below is the JD please have a look. Job Title: IT Enterprise Architect with Life Science Experience Location: Boston, MA (Remote) Duration: 12+ months Job Description: The IT Enterprise Architect is a key role within Gates MRI IT, combing a blend of deep technical and architectural expertise with industry foresight, and strategic thinking. This position is essential for crafting a cohesive IT architecture that sup
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Posted 1 day ago

Veeva Promomats Technical Lead - 100% remote

MSquare Systems Inc.

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Remote

Third Party, Contract

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 53 days ago | Updated 9 days ago

Senior Commissioning, Qualification & Validation (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 6 days ago | Updated 4 hours 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 moments ago

Software Quality Engineering Lead

Johnson & Johnson

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Remote or New Brunswick, New Jersey, 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 16 hours ago | Updated 4 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 50 days ago | Updated 4 hours ago

Staff Software Engineer - Hardware Integration (Remote)

Becton Dickinson & Company

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Remote or San Diego, California, USA

Full-time

Job Description Summary Job Description We are the makers of possible BD is one of the largest global medical technology companies in the world. Advancing the world of health is our purpose, and it's no small feat. It takes the imagination and passion of all of us - from design and engineering to the manufacturing and marketing of our billions of MedTech products per year - to look at the impossible and find transformative solutions that turn dreams into possibilities. We believe that the hu
Posted 2 days ago | Updated 4 hours ago