FDA jobs in Raleigh, NC

Hybrid in Raleigh, North Carolina

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2d ago

Duration: 6 months contract Job Description: We are seeking a Software Engineer for clinical trial team which develops software solutions to improve clinical research and clinical trial operations.The engineer will contribute to building, testing, deploying, and maintaining high-quality, FDA-regulated software applications while collaborating with cross-functional teams. Responsibilities:Design, develop, test, deploy, maintain, and improve software applications.Develop and support full-stack we

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Contract

$59.31 - $77

GRC Analyst

Remote

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3d ago

This is a 3 Month Contract to Hire Opportunity. This position is 100% Remote. This is an outstanding opportunity for a Sr. GRC Analyst to participate in large global GRC initiatives that literally save lives. We are a leading global biotech company committed to improving human health through scientific innovation. With a 50+ year legacy of excellence, our publicly traded organization employs over 7,000 global team members, holds 750+ product patents, and generates $6.6 billion in revenue with $1

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Contract

$60 - $70

Calibration Technician V

Morrisville, North Carolina

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Today

DivIHN (pronounced divine) is a CMMI ML3-certified Technology and Talent solutions firm. Driven by a unique Purpose, Culture, and Value Delivery Model, we enable meaningful connections between talented professionals and forward-thinking organizations. Since our formation in 2002, organizations across commercial and public sectors have been trusting us to help build their teams with exceptional temporary and permanent talent. Visit us at to learn more and view our open positions. Please apply o

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Contract, Third Party

$55 - $56

CSV Lead

Hybrid in Durham, North Carolina

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16d ago

Role - CSV Lead Location- Durham, NC (Hybrid, must visit site 2-3 days a week) Job Description- Must have worked in CSV in Manufacturing automation systems like DELTA V,PI Historian, PLC, LAB Automation Systems(any one pf the systems or all). Primary: CSV (Computer System Validation) Compliance Secondary: SDLC / CSA / Validation Governance / Quality Compliance. Hands-on experience supporting validation and compliance activities for computerized manufacturing systems in a regulated pharmaceutical

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Contract

Depends on Experience

Calibration Technician I

Morrisville, North Carolina

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Today

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Contract, Third Party

Depends on Experience

Senior Controls Engineer - Operational Technology (Durham, NC)

Durham, North Carolina

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Today

California, US residents click here. The job details are as follows: Who We Are We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation. Our public benefit purpose is to provide a brighter future for patients through the development of novel pharmaceutical therapies; and technologies that expand the availability of transplantable organs. United Therapeutics (Nasdaq: UTHR) seeks to travel down the corridors of indifference to develop

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

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

Process Engineer III

Durham, North Carolina

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Today

Job Description Summary Make a meaningful impact by ensuring the reliability and compliance of the equipment and systems that support the development and manufacture of innovative therapies. As a Process Engineer , you will provide engineering support for GMP manufacturing equipment, utilities, facilities, and a broad range of QC laboratory systems. You'll lead equipment lifecycle activities including installation, commissioning and qualification (C&Q), validation, maintenance, and continuous im

Full-time

USD 98,700.00 - 183,300.00 per year

Senior Engineer, Validation

Raleigh, North Carolina

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Today

TITLE: Senior Engineer, Validation 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 of p

Full-time

USD 88,000.00 - 105,000.00 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

Engineer 2/3, Clean Utilities

Holly Springs, North Carolina

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Today

Position Overview The Clean Utilities Engineer 2/ 3 provides engineering support to field personnel in the performance of maintenance and operational tasks associated with Clean Utilities, including reverse osmosis/electrodeionization (RO/EDI) skids, water for injection (WFI), purified water (WPU), Clean gasses and applicable waste systems. This role works directly with other Utility Engineers ensuring applicable safety and regulatory standards are maintained, identifies process improvements, a

Full-time

Validation Engineer - Facilities and Utilities

Clayton, North Carolina

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Today

Description: On-site in Clayton, NC Our client is seeking an experienced Facilities and Utilities Validation Engineer to lead qualification activities for GMP facility modifications, building systems, critical utilities, and supporting infrastructure. The consultant will support multiple projects and coordinate with Engineering, Facilities, Maintenance, Automation, Quality, vendors, and project management. Due to client requirements, applicants must be willing and able to work on a w2 basis.

Contract

Senior Engineer 1/2, CQV

Holly Springs, North Carolina

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Today

Position Overview The Senior CQV Engineer 1 leads the commissioning and qualification of equipment and systems of assigned area for the site. This role performs and leads the CQV team through the validation lifecycle, investigation of deviations and root cause analyses, and establishes standard operating procedures and other documents. This role collaborates with internal and external stakeholders to ensure strategies, equipment, and systems incorporate global standards and align and comply wit

Full-time

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

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

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

Mechanical Engineer/Durham, North Carolina

Durham, North Carolina

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Today

We are the people who give possibilities purpose BD is one of the largest global medical technology companies in the world. Advancing the world of health is our Purpose, and it's no small feat. It takes the imagination and passion of all of us-from design and engineering to the manufacturing and marketing of our billions of MedTech products per year-to look at the impossible and find transformative solutions that turn dreams into possibilities. Job Description Job Summary The Mechanical Engi

Full-time

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

Process Engineer

Raleigh, North Carolina

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14d ago

Responsibilities: Seeking an experienced Process Engineer - Cartridge Filling to support a large-scale sterile pharmaceutical manufacturing expansion. This consultant will provide technical expertise for cartridge filling operations, supporting equipment implementation, startup, commissioning, qualification, process optimization, and commercial manufacturing. Working closely with Manufacturing, Quality Assurance, Validation, Automation, Maintenance, and Project Engineering, this individual will

Full-time

FDA jobs in Raleigh, NC, USA