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Sunnyvale, California

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6d ago

Role name: Validation Engineer Branch | City | Location: Sunnyvale/ Santa Clara, CA Duration: 6 Months Keywords: Key Words to search in Resume Computer System Validation, 21 CFR Part 11, GxP, FDA, 21 CFR Part 11, ISO 13485, IEC 62304 Role Description: Develop, implement, and maintain software quality assurance processes for non-product software used in medical device development.Ensure adherence to regulatory standards (FDA, ISO 13485, IEC 62304) and industry best practices for non-product sof

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Contract

$45 - $50

Medical Device & Regulations Engineer

Santa Clara, California

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Today

Responsibilities: Develop, implement, and maintain software quality assurance processes for non-product software used in medical device development. Ensure adherence to regulatory standards (FDA, ISO 13485, IEC 62304) and industry best practices for non-product software. Support audits and inspections by regulatory bodies, ensuring that non-product software systems comply with quality and documentation standards. Ensure computerized systems are appropriately validated Assessment of applicabil

Full-time

System Validation Engineer

Santa Clara, California

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Today

Full-time

Systems Administrator / Technical Lead - Process Control Systems

Foster City, California

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Today

Job Summary: We are looking for an experienced professional who will be responsible for administration of Rockwell FactoryTalk-based process control systems and Inductive Automation's Ignition-based process control and environmental monitoring systems. The candidate should have hands-on experience deploying, configuring, and troubleshooting these systems in a Good Manufacturing Practice (GMP) environment, with a good understanding of FDA regulations. This role focuses on deploying system updates

Full-time

Senior Software Quality Engineer

Remote or Santa Clara, California

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Today

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

Full-time

USD 105,000.00 - 169,050.00 per year

Sr Manager, IT Business Analysis - SAP BRH Architect

Remote or Foster City, California

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Today

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

Full-time

USD 169,320.00 - 219,120.00 per year

Computer System Validation (CSV) Engineer

Remote or Massachusetts

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Today

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

Full-time

Veeva Presales Consultant

Remote

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Today

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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Contract

Depends on Experience

Veeva Promo Mats Technical Architect-W2

Remote

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6d ago

Job Title: Veeva Promo Mats Technical Architect Duration: 12 Months (Possible Extension) Location: Remote/Hybrid Client Note: Minimum 2-3 end-to-end implementation required on Promo Mats.We are looking who have extensive experience in PROMOMATS. Only ask those who are hands-on with the projects who can describe the details of the project. Need Promo Mats expertiseJob Description Join IBM's Veeva Practice team as an Architect & Engineer for Veeva Commercial Cloud, where you will be a key leader i

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Contract

Depends on Experience

Veeva PromoMats Technical Architect - W2

Remote

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Today

Job Title: Veeva PromoMats Technical Architect Duration: 12 Months (Possible Extension) Location: Remote/Hybrid Client Note: Minimum 2-3 end-to-end implementation required on PromoMats.We are looking who have extensive experience in PROMOMATS. Only ask those who are hands-on with the projects who can describe the details of the project. Need PromoMats expertise Job Description Join IBM's Veeva Practice team as an Architect & Engineer for Veeva Commercial Cloud, where you will be a key leader in

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Contract

Depends on Experience

Lead Engineer - MES Opcenter

Remote or New York

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Today

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

Full-time

Computer System Validation Analyst - R Studio & Clinical Systems

Remote or New Jersey

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Today

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

Full-time

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

Remote

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3d ago

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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Full-time

Depends on Experience

Veeva Promomats Technical Lead - 100% remote

Remote

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4d ago

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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Third Party, Contract

Depends on Experience

Senior Commissioning, Qualification & Validation (CQV) Engineer

Remote or Athens, Georgia

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Today

Full-time

LIMS and QC Applications Consultant

Remote or Hybrid in Bridgewater, New Jersey

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Today

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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Full-time, Contract

BASED ON EXPERIENCE

Sr. Manager, SAP CGTO Solutions Architect

Remote or Santa Monica, California

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Today

Full-time

USD 153,935.00 - 199,210.00 per year

Staff Engineer Distribution Quality (Hybrid)

Remote or Covington, Georgia

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Today

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

Full-time

Principal Software Engineer

Remote or Thousand Oaks, California

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Today

Career Category Information Systems Job Description Join Amgen's Mission of Serving Patients At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of pati

Full-time

USD 148,436.00 - 190,516.00 per year

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