21 cfr part 11 Jobs in denver, co

Refine Results
1 - 20 of 28 Jobs

Lead Engineer MES OpCenter

New York Technology Partners

•

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
Easy Apply
Posted 8 days ago

SDET Data Quality Engineer

Judge Group, Inc.

•

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 40 days ago | Updated 10 hours ago

Validation Engineer 4

Katalyst Healthcares and Lifesciences

•

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 33 days ago | Updated 2 hours ago

Sr Data SDET

Apex Systems

•

Lakewood, Colorado, USA

Full-time

Job#: 2073875 Job Description: JOB SUMMARY As a Senior SDET - Data Quality Engineer, you will design, build, and maintain automated data validation frameworks and pipelines. You will work closely with data engineers, software developers, QA, DevOps, and compliance teams to embed robust data quality checks into our data ecosystem. This is a senior, hands-on role that demands technical expertise in automation, data engineering, and SDET best practices. You'll champion data testing in a highly re
Easy Apply
Posted 14 days ago | Updated 2 hours ago

Systems Engineer (IBM DOORS Next Gen, DNG, ETM)

Dynamic Enterprise Solutions Inc

•

Remote

Contract, Third Party

Description: Responsible for configuration of IBM Rationale SaaS systems, specifically DOORS Next Gen (DNG) and Engineering Test Management (ETM). - Must have significant experience leading implementation and configuration of those systems. - Including project management, working cooperatively with subject matter experts, knowledge and implementation of best practices of medical device product development utilizing the specific IBM systems. - Nice to have additional expertise in medical devices
Easy Apply
Posted 17 days ago

Life Sciences Compliance SME

Avance Consulting

•

Remote

Full-time

Life Sciences Compliance SME Indianapolis, IN Fulltime Required Qualifications: At least 6 years of Information Technology experience. Strong Quality and compliance experience. Performing on project teams and providing deliverables involving the evaluation of IT quality and GxP issues in an FDA regulated environment Evaluating IT risk issues, including the use of data and technology to provide greater coverage, targeted precision and insight Evaluating IT and business controls, including those r
Easy Apply
Posted 9 days ago | Updated 4 hours ago

.NET Developer Build Resource- Pharma Experience

Sansar Tec

•

Remote

Contract

Job Title: .NET Developer Build ResourceLocation: RemoteType: Long Term ContractJob Summary:We are seeking a skilled and experienced .NET Developer to join our project team supporting a pharmaceutical client. The selected resource will be responsible for building, enhancing, and deploying .NET-based applications to support clinical, commercial, or operational initiatives within the pharma domain. The ideal candidate should have a strong foundation in software engineering, experience working in r
Easy Apply
Posted 4 hours ago

Computer System Validation Analyst - R Studio & Clinical Systems

Katalyst Healthcares and Lifesciences

•

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 36 days ago | Updated 2 hours ago

Veeva Clinical Architect

Arnex Solutions LLC

•

US

Third Party, Contract

Responsibilities: Solution Architecture Design: Lead the design and architecture of Veeva Vault solutions, ensuring alignment with business requirements and industry best practices. Develop and document high-level and detailed solution designs, including data models, workflows, integration patterns, and security frameworks. Implementation Oversight: Oversee the implementation of Veeva Vault applications, ensuring adherence to architectural standards and project timelines. Provide technical leade
Posted 6 days ago | Updated 10 hours ago

LABWARE Resource / Consultant

Intone Networks Inc.

•

Remote or US

Full-time, Contract, Third Party

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
Easy Apply
Posted 23 days ago | Updated moments ago

Maximo Enterprise Asset Management (EAM)

Chabez Tech LLC

•

Remote

Contract

Role: Maximo Enterprise Asset Management (EAM) Specialist with Life Science Industry Experience Job Location:- Remote OVERVIEW: Expert Enterprise Asset Management (EAM) Specialist/ Functional Lead/ System Architect is needed to support PSG OneMaximo team for migration to MAS 9.X. The successful candidate must have a proven track record of implementing, customizing, and supporting EAM systems with certification in Maximo Application Suite (MAS). Proficiency with system integrations, change manag
Easy Apply
Posted 1 day ago

Veeva Promomats Technical Lead - 100% remote

MSquare Systems Inc.

•

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
Easy Apply
Posted 16 days ago | Updated 2 days ago

MES Consultant

BOTG LLC

•

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
Easy Apply
Posted 45 days ago | Updated 8 days ago

Maximo EAM Specialist

McKinsol Consulting Inc

•

Remote

Third Party, Contract

Key Skills: 15 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 Experience with ABS Proprietary Tools for Data Migration and Data Archival 15 years of Life Science International system support incl
Easy Apply
Posted 3 days ago | Updated 1 day ago

LIMS and QC Applications Consultant

Expedite Technology Solutions

•

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
Easy Apply
Posted 60+ days ago | Updated moments ago

Sr. Manager, SAP CGTO Solutions Architect

Gilead Sciences, Inc.

•

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 13 days ago | Updated 2 hours ago

IBM Maximo EAM Specialist

NTT DATA Americas, Inc

•

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
Easy Apply
Posted 17 days ago | Updated moments ago

Senior CQV Engineer

Johnson & Johnson

•

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 38 days ago | Updated 2 hours ago

Lead Technology Solutions Engineer - PAS-X MES

Johnson & Johnson

•

Remote or Raritan, 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 2 days ago | Updated 2 hours ago

Maximo Global Admin

Chabez Tech LLC

•

Remote

Third Party, Contract

OneMaximo Global Admin - Life Science Industry Experience Job Location:- Remote Notes - IT OneMaximo Staff Aug as Global System Admin requires in-depth understanding of the OneMaximo system and configurations, including proprietary tools from ABS Consulting. This position supports the system infrastructure (for 5 environments) 11 global sites, performance monitoring, with understanding of OMX policies and procedures to support potential Global TrackWise Deviations, CIS policies and procedures, n
Easy Apply
Posted 1 day ago | Updated 1 day ago