21 cfr part 11 Jobs in portland, or

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Veeva Technical Architect with PromoMats Focus

Vigna Solutions Inc.

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Remote

Contract

Role: Veeva Technical Architect with PromoMats Focus Location: Remote JD Expertise with PromoMats at least two end-to-end PromoMats implementations Required Qualifications: Prior consulting experience.5+ years of hands-on experience with Veeva Vault, including PromoMats, MedComms, Modular Content, DAM, and Claims modules, with at least two end-to-end PromoMats implementations.In-depth knowledge of life sciences regulatory frameworks (e.g., GxP, 21 CFR Part 11), MLR processes, and experience supp
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Posted 2 days ago

Veeva Technical Architect (PromoMats Expert)

Sierra Software Solutions

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Remote

Contract

Job Title: Veeva Technical Architect (PromoMats Expert)Location: RemoteRate: $75+/hr Job Description:We are seeking an experienced and highly skilled Veeva Technical Architect with deep expertise in Veeva Vault PromoMats to join IBM s Veeva Practice. In this role, you will lead architecture, design, and technical solutioning efforts across multiple life sciences clients, focusing on compliant promotional materials management and integration into enterprise platforms. You will act as a trusted ad
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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 3 days ago | Updated 7 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 12 days ago | Updated 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 12 days ago | Updated 7 hours 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 59 days ago | Updated 7 hours 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 39 days ago | Updated 25 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 moments 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 37 days ago | Updated 6 hours 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 41 days ago | Updated moments ago

Sr Manager, IT Business Analysis - SAP BRH Architect

Gilead Sciences, Inc.

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Remote or Foster City, 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 1 day ago | Updated 6 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 60+ days ago | Updated 19 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