21 cfr part 11 Jobs in denver, co

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Veeva Technical Architect (Commercial Cloud Focus)

HPTech Inc.

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Remote

Contract

Key Responsibilities: Partner with IBM account teams and clients to understand their mission, business processes, and technical requirements.Lead technical discovery sessions and workshops with clients to refine requirements and validate solution designsDesign scalable Veeva Vault PromoMats solutions aligned with business needs, regulatory requirements (e.g., 21 CFR Part 11) and Veeva best practices.Lead the full lifecycle of promotional material management, including submission intake, MLR/PRC
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Posted 10 days ago | Updated 4 days ago

SDET Data Quality Engineer

Judge Group, Inc.

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Denver, Colorado, USA

Full-time

Location: Denver, CO Salary: $65.00 USD Hourly - $75.00 USD Hourly Description: About the job Join a global medical-device & cell-therapy organization as a Senior SDET / Data-Quality Engineer. You'll automate data-quality pipelines on our Azure/Databricks lakehouse to ensure regulatory-grade, analytics-ready datasets for upcoming post-market analytics releases. Responsibilities Design, develop, and maintain automated data-validation frameworks for batch & streaming pipelines in Databricks.
Posted 22 days ago | Updated 6 hours 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 27 days ago

LABWARE Resource / Consultant

Intone Networks Inc.

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Remote or US

Full-time, Third Party, Contract

LABWARE Resource / Consultant 100% Remote Long Term Key Responsibilities: Design, configure, and program within LabWare LIMS Version 8 and Biovia OneLab to meet business and laboratory requirements. Develop and maintain Crystal Reports for operational and analytical reporting. Implement and manage laboratory instrument and external system integrations using both file-based and API-based methods. Collaborate with cross-functional teams to analyze requirements, document functional specificat
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Posted 4 days ago | Updated 22 hours ago

LabVantage LIMS Architect

I.T. Solutions

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Remote

Contract

Role: Sr. LabVantage LIMS Architect Location: Remote Type: Contract Length: 3 months to start + Likely Extensions We are seeking an experienced LabVantage LIMS Architect to lead the design, configuration, and implementation of LabVantage Laboratory Information Management Systems (LIMS). The ideal candidate will possess deep technical expertise in LabVantage, a strong understanding of laboratory workflows, and a proven ability to align LIMS capabilities with business and regulatory requirements.
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Posted 16 days ago

Trackwise Digital Architect

VeridianTech

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Texas, USA

Full-time

Trackwise Digital Architect Remote Requirement Experience with designing and implementing IT systems. Experience with understanding specifications, evaluate current application, gather requirements, and work closely with stakeholders to deliver the right solution Experience working and implementing systems using TrackWise Digital platform. Hands on experience in TrackWise Digital Application setup: Permission Sets, Configuring Platform Custom Settings, Configuring Remote Site Settings, E-s
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Posted 60+ days ago | Updated 1 day 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 53 days ago | Updated moments 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 17 days ago | Updated 9 hours 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 14 days ago | Updated 9 hours ago

Staff Engineer Distribution Quality (Hybrid)

Becton Dickinson & Company

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Remote or Covington, Georgia, USA

Full-time

Job Description Summary As a Quality Engineer at our Distribution Center, you will be instrumental in upholding the highest standards of regulatory compliance and product quality. Your role is critical in maintaining operational excellence, with a strong focus on the quality engineering processes specific to the distribution of medical devices and pharmaceuticals. Job Description We are the makers of possible BD is one of the largest global medical technology companies in the world. Advancing
Posted 6 days ago | Updated 9 hours ago

Oracle Business Systems Analyst- Order Management

Eliassen Group

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Anywhere, US

Contract

Description: **100% Remote** For over thirty years, our client has been expanding the boundaries of noninvasive monitoring to improve patient outcomes and reduce the cost of care, delivering a portfolio of hospital-trusted monitoring solutions to help increase patient safety, health, and wellness in the hospital and at home. When you join, you'll be part of a c ulture driven by passion, challenging the status quo, and making a positive impact in the lives of others. The Sr Business Systems An
Posted 2 days ago | Updated 9 hours ago

Sr Manager, Data Sciences

Thermo Fisher Scientific

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Remote or Chicago, Illinois, USA

Full-time

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description At Thermo Fisher Scientific, you'll discover impactful work, innovative thinking and a culture dedicated to working the right way, for the right reasons - with the customer always top of mind. The work we do matters, like helping customers find cures for cancer, protecting the environment, making sure our food is safe and delivering COVID-19 solutions. As the world leader in serving science, with the largest inve