21 CFR Part 11 jobs in Boston, MA

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

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

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

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

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

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

Director, Data Management

Waltham, Massachusetts

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Today

Job Description This role provides strategic and operational leadership for Clinical Data Management activities supporting the company's clinical development portfolio. This position is responsible for ensuring the delivery of high-quality, reliable, and inspection-ready clinical data through effective planning, oversight, and execution of data management activities across both internally managed and outsourced clinical studies. The Director partners closely with cross-functional stakeholders,

Full-time

USD 205,000.00 - 230,000.00 per year

CSV Systems Engineer III

Hopkinton, Massachusetts

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Today

Job Description CSV Systems Engineer in Hopkinton, MA Build your future at Curia, where our work has the power to save lives. The CSV Systems Engineer will be responsible for supporting Quality Management Systems and Computer System Validation efforts. This role will provide guidance and expertise on various global and site CSV projects to ensure that quality teams have the necessary tools to provide quality metrics, measurements, and reports for internal audits and inspections. Curia is a g

Full-time

USD 122,800.00 - 145,300.00 per year

Controls Engineer

Wilmington, Massachusetts

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Today

We have a Controls Engineering position available in our Wilmington, MA office. This person will support controls engineering project requirements involving PLC programming, DCS programming, HMI/SCADA programming, database management, control panel design, instrumentation specification, engineering documentation support, check-out support and commissioning assistance. Major Responsibilities This position requires the Controls Engineer to conceptualize, detail and implement control systems for

Full-time

Lead Computer Systems Validation Engineer I (Clinical & R&D)

Waltham, Massachusetts

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Today

Job Description This position provides leadership and accountability for Digital Quality across the organization's Quality, Regulatory, and R&D systems landscape, with responsibility for supporting computer system validation activities in alignment with applicable regulatory expectations, internal procedures, and data integrity requirements. The role is focused on ensuring GxP computerized systems are implemented, maintained, and governed in a compliant, risk-based, and inspection-ready manner

Full-time

USD 110,000.00 - 126,000.00 per year

Senior Systems Engineer - NetSuite

Marlborough, Massachusetts

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Today

About Sequel Sequel, headquartered in Manchester, New Hampshire, is a company developing the next generation of transformative drug-delivery advancements starting with diabetes. Sequel's approach is to look at diabetes management holistically to advance systems that make living with diabetes simpler and easier for all. Sequel's flagship product, the twiist Automated Insulin Delivery (AID) System, launched in July 2025 for people with type 1 diabetes providing them with personalized diabetes mana

Full-time

USD 125,000.00 - 165,000.00 per year

Senior Engineer, Quality Engineering

Wilmington, Massachusetts

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Today

About Analog Devices Analog Devices, Inc. (NASDAQ: ADI) is a global semiconductor leader that bridges the physical and digital worlds to enable breakthroughs at the Intelligent Edge. ADI combines analog, digital, AI, and software technologies into solutions that combat climate change, reliably connect humans and the world, and help drive advancements in automation and robotics, mobility, healthcare, energy and data centers. With revenue of more than $11 billion in FY25, ADI ensures today's inno

Full-time

USD 95,600.00 - 131,450.00 per year

Pharma IT Testing & Validation Delivery Lead

Boston, Massachusetts

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14d ago

Job Summary: leading organization is seeking an experienced Pharma IT Testing & Validation Delivery Lead to manage global testing and validation services across multiple Life Sciences programs. Roles & Responsibilities: Own end-to-end testing and validation delivery across multiple pharmaceutical IT projects. Lead onsite and offshore QA teams across the United States, United Kingdom, and India. Define testing strategy, governance, KPIs, delivery standards, and quality metrics. Oversee functional

Full-time

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

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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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

21 CFR Part 11 jobs in Boston, MA, USA