21 CFR Part 11 jobs in Massachusetts

Remote

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3d 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

Computer Systems Validation Engineer

Boston, Massachusetts

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Today

Are You Ready? CAI is a professional services company established in 1996 that has grown to more than 700 people worldwide. We provide commissioning, qualification, validation, startup, project management, and other consulting services associated with operational readiness to FDA-regulated and other mission-critical industries. Our approach is simple-we put the client's interests first, we don't stop until it's right, and we do whatever it takes to get there. Our Foundational Principles: - W

Full-time

USD 75,000.00 - 106,000.00 per year

Loftware Spectrum Technical Lead / Solution Engineer

Remote

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10d 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

SAP Validation

Remote

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23d 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

Computer System Validation (CSV) Lead - Oracle Fusion

Boston, Massachusetts

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22d ago

No OPT/CPT Job Summary We are seeking an experienced Oracle Fusion Computer System Validation (CSV) Lead to support the implementation, validation, and ongoing lifecycle management of Oracle Fusion applications within a regulated life sciences environment. The ideal candidate will have strong experience validating Oracle Fusion Cloud ERP applications, leading risk-based CSV/CSA activities, and ensuring compliance with 21 CFR Part 11, EU Annex 11, GAMP 5, data integrity, and applicable GxP requi

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Full-time

55 - 60

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

•

Yesterday

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

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

Windchill Solution Architect

Remote

•

Yesterday

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

VP of Technology

Needham, Massachusetts

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Today

Description We are looking for a strategic and hands-on technology executive to guide the company's IT direction during a pivotal stage of growth in Needham, Massachusetts. This leader will shape enterprise systems, cybersecurity, infrastructure, data capabilities, and digital innovation while partnering closely with senior leadership and cross-functional teams. The role is responsible for building scalable, compliant, and business-ready technology operations that support clinical development an

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Full-time

USD 300,000.00 - 350,000.00 per year

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

•

10d 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

QC IT Operations Support

Lexington, Massachusetts

•

Today

Location: Lexington, MA Salary: $60.00 USD Hourly - $90.00 USD Hourly Description: Position Summary We are seeking a QC IT Application Analyst to support Quality Control IT (QCIT) operations within a GMP-regulated biopharmaceutical manufacturing environment. This individual will provide technical support for laboratory and quality systems, manage validation and compliance activities, support application lifecycle management, and partner with Quality, Validation, Product Development, and IT te

Contract

USD 60.00 - 90.00 per hour

Senior Principal GMP Compliance Auditor

Cambridge, Massachusetts

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Today

Location: Cambridge, MA Salary: $95.00 USD Hourly - $135.00 USD Hourly Description: Title: Principal GMP Compliance Auditor Type: 10+ Month Contract Location: Remote with travel domestic and international Seeking a Senior Principal GMP Compliance Auditor to lead independent GMP audits across pharmaceutical manufacturing sites, laboratories, suppliers, CMOs, and quality systems. This role serves as a subject matter expert in global regulatory compliance, inspection readiness, and quality sys

Contract

Compensation information provided in the description

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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Contract, Third Party

Sr. Clinical Developer/ SME (R+Clinical)

Remote or Hybrid in Tampa, Florida

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8d 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

21 CFR Part 11 jobs in Massachusetts, USA