21 CFR jobs in Raleigh, NC

Clinical IT Business Analyst (VISA INDEPENDENT CANDIDATES ONLY)

Raleigh, North Carolina

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Today

Regulated environments such as CRO organizations experience is Huge plus Job Purpose: The Senior Business Analyst (SBA) partners closely with business and technical stakeholders to uncover the true needs of the organization and translate them into clear, actionable, and testable requirements. This role ensures solutions are designed with the end user in mind while meeting enterprise, quality, and regulatory expectations. Key Accountabilities: Elicit and define business requirements Identify true

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Contract, Third Party

Depends on Experience

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

Automation & Controls Engineer

Raleigh, North Carolina

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Today

TITLE: Automation & Controls Engineer WHO WE ARE Indivior is a global pharmaceutical company working to help change patients' lives by developing medicines to treat Opioid Use Disorder (OUD). Our vision is that all patients around the world will have access to evidence-based treatment for OUD, and we are dedicated to transforming OUD from a global human crisis to a recognized and treated chronic disease. Building on its global portfolio of OUD treatments, Indivior has an exploratory pipeline o

Full-time

USD 98,000.00 - 115,500.00 per year

Commissioning, Qualification, and Validation (CQV) Engineer

Raleigh, North Carolina

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Today

Company Description Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate.

Full-time

Automation Engineer III - Compounding/CIP/SIP/Utility Distribution

Durham, North Carolina

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Today

Job Description Summary Imagine using your automation expertise to support the systems that enable safe, compliant, and reliable pharmaceutical manufacturing every day. As an Automation Engineer focused on Compounding, CIP, SIP, and Utility Distribution systems, you'll help ensure critical process automation platforms operate at peak performance while supporting the production of medicines for patients worldwide. Working across Engineering, Manufacturing, and Quality, you'll drive troubleshooti

Full-time

USD 98,700.00 - 183,300.00 per year

Sr. Automation Engineer - Upstream/Media

Durham, North Carolina

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Today

Job Description Summary Ready to help power the next generation of life-changing therapies? As a Sr. Automation Engineer - Upstream/Media, you will play a critical role in supporting the automation systems that drive upstream manufacturing and media preparation operations. You'll serve as a technical leader within a GMP environment, partnering with cross-functional teams to optimize process performance, enhance system reliability, and deliver automation solutions that enable consistent, complian

Full-time

USD 108,500.00 - 201,500.00 per year

Automation Engineer III - BMS/PLC/OEM

Durham, North Carolina

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Today

Job Description Summary Imagine being the automation expert who helps keep critical manufacturing systems running seamlessly while supporting the production of medicines that impact patients around the world. As an Automation Engineer focused on BMS, PLC, and OEM systems, you'll play a key role in maintaining and enhancing complex manufacturing automation platforms, partnering across Engineering, Manufacturing, and Quality teams to deliver reliable, compliant, and efficient operations. This is

Full-time

USD 98,700.00 - 183,300.00 per year

Senior Engineer, Automation - Packaging/Serialization

Durham, North Carolina

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Today

Job Description Summary Ready to help ensure life-changing medicines reach patients safely and reliably? As a Senior Engineer, Automation - Packaging/Serialization, you will provide technical leadership for the automation systems that support packaging operations, serialization processes, and product traceability across the manufacturing environment. Working within a GMP-regulated facility, you'll drive automation innovation, enhance system performance, and lead critical projects that strengthen

Full-time

USD 108,500.00 - 201,500.00 per year

Sr. Automation Engineer - Downstream/Buffer

Durham, North Carolina

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Today

Job Description Summary Ready to make a direct impact on the delivery of life-changing medicines? As a Sr. Automation Engineer - Downstream/Buffer, you will serve as a key technical leader supporting the automation systems that enable reliable, compliant, and efficient manufacturing operations. Working across complex GMP production environments, you'll drive automation strategy, lead critical projects, troubleshoot advanced control systems, and partner with cross-functional teams to continuously

Full-time

USD 108,500.00 - 201,500.00 per year

Sr. Automation Engineer - DeltaV

Durham, North Carolina

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Today

Job Description Summary Join Novartis and play a pivotal role in advancing manufacturing automation that helps deliver innovative medicines to patients worldwide. As a Sr. Automation Engineer - DeltaV, you will serve as a key technical expert supporting and optimizing critical automation systems within a GMP-regulated manufacturing environment. This is an opportunity to lead impactful automation initiatives, drive system reliability and performance, and collaborate with cross-functional teams to

Full-time

USD 108,500.00 - 201,500.00 per year

Senior Process Engineer - Compliance #4968

Durham, North Carolina

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Today

Our mission is to detect cancer early, when it can be cured. We are working to change the trajectory of cancer mortality and bring stakeholders together to adopt innovative, safe, and effective technologies that can transform cancer care. We are a healthcare company, pioneering new technologies to advance early cancer detection. We have built a multi-disciplinary organization of scientists, engineers, and physicians and we are using the power of next-generation sequencing (NGS), population-scal

Full-time

USD 95,000.00 - 125,000.00 per year

Equipment Validation Engineer 2

Durham, North Carolina

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Today

Position Overview We are seeking an Equipment Validation Engineer II to support the qualification of manufacturing equipment and utilities in our GMP facility. You will develop and execute risk-based validation strategies, author and run IQ/OQ/PQ protocols, and partner with cross-functional teams to ensure compliant, reliable operations. Company Overview At FUJIFILM Biotechnologies, we're leading the charge in advancing tomorrow's medicines. If you want to be a part of life-impacting projects

Full-time

IT/OT Senior Lab Specialist

Durham, North Carolina

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Today

Job Description Summary Join Novartis and play a critical role in enabling cutting-edge laboratory operations that help bring innovative medicines to patients. As an IT/OT Senior Lab Specialist, you will lead the strategy, implementation, and lifecycle management of computerized laboratory systems across GMP and non-GMP environments, ensuring reliability, compliance, and operational excellence. This is an opportunity to work at the intersection of technology, quality, and science, partnering wit

Full-time

USD 108,500.00 - 201,500.00 per year

Assoc Director, IT Systems Engineering

Raleigh, North Carolina

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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 168,980.00 - 218,680.00 per year

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

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

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

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

21 CFR jobs in Raleigh, NC, USA