21 cfr part 11 jobs in houston, tx

Remote

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4d ago

Role : Loftware Spectrum Technical Lead / Solution Engineer Position Summary Responsible for the technical design, configuration, integration, support, and lifecycle management of Integer's Loftware Spectrum enterprise labeling platform. This role serves as the primary technical resource between Labeling COE, SAP, Oracle, manufacturing sites, Quality, and implementation partners to ensure a scalable, compliant, and supportable global labeling solution. The individual will lead architecture, busi

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Contract, Third Party

Depends on Experience

Loftware Spectrum Technical Lead / Solution Engineer

Remote

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11d ago

At NTT DATA, we know that with the right people on board, anything is possible. The quality, integrity, and commitment of our employees have been key factors in our company's growth and market presence. By hiring the best people and helping them grow both professionally and personally, we ensure a bright future for NTT DATA and for the people who work here. For more than 25 years, NTT DATA Services have focused on impacting the core of your business operations with industry-leading outsourcing

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Contract

Depends on Experience

MES Engineer

Houston, Texas

•

Today

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work-but i

Full-time

USD 66,000.00 - 158,400.00 per year

SAP Validation

Remote

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24d ago

Job Title: SAP Validation Life Sciences & Pharmaceuticals Location: Remote Duration : Long term ONLY SAP VALIDATION PROFILES Required Qualifications Bachelor s degree in computer science, Information Technology, Engineering, Life Sciences, or related field. 8+ years of experience in SAP validation or Computer System Validation (CSV). GxP regulations 21 CFR Part 11 Annex 11 GAMP 5 Experience with validation tools and documentation management systems. Familiarity with change management and deviat

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Contract

Depends on Experience

CSA/CSV Validation Consultant

Remote or Arlington, Virginia

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Yesterday

Role - CSA/CSV Validation Consultant Remote Skills & Experience Required: empower or similar HPLC software Deep expertise in validating GxP-regulated IT systems within the Pharma/Life Sciences domain Familiarity with QMS processes including deviation management, CAPA, and change control. Strong command of CSA (Computer Software Assurance) principles Solid knowledge with 21 CFR Part 11, Annex 11, ISPE AI guidance, GxP data integrity principles (ALCOA+). Proven ability to write and manage valida

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Contract

PLM Windchill Solution Architect/ SME

Remote

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Today

Position SummaryWe are seeking a highly experienced Windchill PLM Subject Matter Expert to assess the current PTC Windchill environment and develop a strategic upgrade roadmap for Windchill 2027. The ideal candidate will have strong technical and functional expertise in Windchill, PLM transformation, system upgrades, data migration, and integrations within regulated industries, preferably Medical Devices. Key ResponsibilitiesAssess the existing Windchill environment, including configurations, cu

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Contract, Third Party

Depends on Experience

Product Owner

Remote

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9d ago

Role OverviewThe Product Owner for the Clinical Trial Platform is responsible for defining the product vision, strategy, and roadmap for technology that supports end to end clinical trial execution.This role blends product management discipline with deep understanding of regulated clinical workflows, ensuring the platform delivers measurable value to sponsors, CROs, research sites, and patients. The PM drives feature development across study startup, patient identification, eligibility, randomiz

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Contract, Third Party

$80 - $85

PLM Windchill Solution Architect/ SME

Remote

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2d ago

Role : PLM Windchill Solution Architect/ SME Location : Remote Type : Contract Required Skills & Experience Windchill Expertise 12+ years of hands-on experience with PTC Windchill. Expertise across: Windchill PDMLink ProjectLink MPMLink PartsLink Change Management Document Management Configuration Management Strong knowledge of Windchill versions 12.x/13.x and roadmap toward Windchill 2027. Experience with Windchill upgrades, migrations, and modernization programs. Technical Skills

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Contract, Third Party

Depends on Experience

Computer Vision Engineer

Remote

•

Yesterday

Role: Computer Vision EngineerLocation: Remote with travel required 50%Duration: 6months with possible extensionRole OverviewWe are seeking a Computer Vision Engineer to own the development and integration of real-time automated visual inspection systems for our pharmaceutical packaging lines. In this role, you will design and deploy edge-based vision models that interface with high-speed cameras and IoT hardware to detect packaging defects, verify serialization, and ensure 100% quality complian

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Contract

Depends on Experience

Product Owner

Remote

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17d ago

Iris's direct client, a leader in Healthcare services, looking to hire a strong Product Owner for a Long-Term Contractual role Job title: Product Owner Location: 100% Remote Duration: 18 Months Skills: Product Owner, Clinical Trial Platform Job Description: Product Manager Clinical Trial Platform Role Overview The Product Manager for the Clinical Trial Platform is responsible for defining the product vision, strategy, and roadmap for technology that supports end-to-end clinical trial executio

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Contract

Depends on Experience

Windchill Solution Architect

Remote

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2d ago

Job Description: Summary Seeking an experienced Windchill PLM SME to assess the current PTC Windchill landscape and define the upgrade strategy and roadmap for Windchill 2027. Preference for candidates with a strong Medical Devices background; Life Sciences and Healthcare experience will also be considered. Responsibilities Assess existing Windchill configuration, customizations, workflows, data models, infrastructure, and integrations.Evaluate Windchill 2027 readiness, upgrade risks, technical

Contract

$100 - $130

Clinical Trial Product Owner

Remote

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7d ago

We are hiring for a Product Owner. It s a long-term contract role // Fully Remote role. Title : Product Owner Work Schedule: Fully Remote role. Required Skills : Product Owner with Pharma or Clinical Trial Platform Please email me your resume at Role Overview The Product Owner for the Clinical Trial Platform is responsible for defining the product vision, strategy, and roadmap for technology that supports end to end clinical trial execution. This role blends product owner discipline with deep

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Full-time

Depends on Experience

SAP S/4HANA Program / Project Manager

Remote

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6d ago

Job Description: SAP S/4HANA Program / Project ManagerExperience: 12+ Years Role: SAP Program / Project Manager Key Skills: SAP S/4HANA, SAP EWM, MM, SD, PP, WM, SAP Activate, Program Governance, Cutover, Data Migration Job Overview : We are looking for an experienced SAP Program / Project Manager to lead large-scale SAP S/4HANA implementations, supply chain transformations, and global rollouts. The ideal resource should have strong experience managing cross-functional teams, system integrator

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Contract, Third Party

Depends on Experience

Loftware Spectrum Technical Lead / Solution Engineer @ Remote

Remote

•

11d ago

Position: Loftware Spectrum Technical Lead / Solution Engineer Location: Remote Duration: 6+ months Job Description: Position Summary Responsible for the technical design, configuration, integration, support, and lifecycle management of Integer's Loftware Spectrum enterprise labeling platform. This role serves as the primary technical resource between Labeling COE, SAP, Oracle, manufacturing sites, Quality, and implementation partners to ensure a scalable, compliant, and supportable g

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Contract, Third Party

Depends on Experience

MLops Engineer (Remote)

Remote

•

Today

Join TetraScience, the Scientific Data and AI Cloud company, as a Lead Software Platform Engineer working at the intersection of distributed systems and MLOps. In this role, you will own and scale AI and data infrastructure that supports production-grade AI/ML workflows for scientists at some of the world's largest pharmaceutical companies. This is a highly impactful opportunity for an engineer who has built AI/ML infrastructure as a multi-tenant product rather than internal tooling. You will s

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Full-time

$200 - $270

Sr. Clinical Developer/ SME (R+Clinical)

Remote or Hybrid in Tampa, Florida

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9d ago

Hi, Job DetailsPosition: Senior Clinical Developer/SME (R + Clinical)Location: Anywhere on the U.S. East CoastExperience Required: 8+ years of deep R programming experiencePrimary Skills: R, Pharmacokinetics (PK/PD), Clinical Data Processing, CDISC SDTM/ADaMKey Technologies: R Shiny, tidyverse, data.table, PKNCA, mrgsolve, rxode2Clinical Modeling Tools: NONMEM, Monolix, Phoenix WinNonlinReporting Tools: R Markdown, QuartoWork Arrangement: HybridRole OverviewWe are seeking an experienced Senior C

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Third Party, Contract

65 - 70

Veeva Vault Configurator Clinical Suite

Remote

•

Today

Solution IT Inc. is looking for Veeva Vault Configurator Clinical Suite for one of its clients in Remote Job Title: Veeva Vault Configurator Clinical Suite Veeva Vault Configuration & Enhancements Configure and maintain Veeva Vault R&D applications (e.g., Vault Clinical, Vault RIM, Vault Quality, Vault Safety, or related modules). Develop and maintain objects, fields, lifecycles, workflows, roles, picklists, document types, and other Vault components. Execute configuration deployments, manage

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Third Party, Contract

Loftware Spectrum Technical Lead

Remote

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10d ago

Hello, We have an opening for the role mentioned below with Our client. Please review the job description and let me know if it aligns with your experience and interests. If so, kindly share your updated resume. Thank you. Loftware Spectrum Technical Lead / Solution Engineer Remote Position Summary Responsible for the technical design, configuration, integration, support, and lifecycle management of Integer's Loftware Spectrum enterprise labeling platform. This role serves as the prima

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Third Party, Contract

Depends on Experience

Planisware PPM Administrator w/ Power BI

Remote

•

Today

Systems / Data Analyst Location: Remote (Easter Time Zone) Contract Duration: 12 Months plus Start Date: ASAP About the Role Our client is seeking an experienced Systems / Data Analyst to support its Technical Services organization within the pharmaceutical and life sciences industry. This position will serve as the primary Planisware System Administrator, with responsibility for platform configuration, governance, user access, and ongoing enhancements. The Systems / Data Analyst will also d

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Contract

Sr SampleManager Implementation Engineer

Remote or Indiana

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Today

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Senior SampleManager LIMS Implementation Engineer How will you make an impact? As a Senior SampleManager LIMS Implementation Engineer, you will be a technical expert responsible for the configuration, implementation, integration, and deployment of Thermo Scientific SampleManager LIMS solutions. This role is highly hands-on and focused on translating defined laboratory processes and solution designs into robus

Full-time

USD 93,800.00 - 140,675.00 per year

21 cfr part 11 jobs in Houston, TX, USA