FDA Jobs in Raleigh, NC

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W2 only Software Quality Assurance Consultant - EST/CST Only - regulatory affairs Medical Devices, software development life cycle risk management and configuration management FDA

APN Software Services, Inc

•

Remote

Contract

Please contact Abdul on "" OR email me at "" Job Responsibilities: Provides guidance and quality oversight of the development, testing strategy, validation, and documentation of biomedical software, ensuring compliance with established procedures and regulatory requirements. 2. Participates as an integral team member in various phases of the Software Development Life Cycle (SDLC), providing timely and meaningful feedback for project documentation including software requirements, design, test pl
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Posted 7 days ago | Updated 1 day ago

LIMS and QC Applications Consultant

Expedite Technology Solutions

•

Remote or Bridgewater, New Jersey, USA

Full-time, Contract

Solution Architecture and Design: Lead the design and development of LabVantage LIMS solutions tailored to business and laboratory needs. Develop system workflows, configurations, and integrations with other enterprise systems (e.g., S4 Hana ERP, MES, ELN, SDMS). Define data models, interface designs, and system configurations. Implementation and Deployment: Oversee installation, configuration, and validation of LabVantage LIMS applications. Develop and execute project plans, ensuring timely an
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Posted 59 days ago | Updated 8 hours ago

Medical Devices Software Program Manager (REMOTE/WEST COAST CANDIDATES)

Amerit Consulting

•

Remote

Contract

Our client, a US Fortune 250 company and a global Medical technology corporation serving customers in Clinical Labs, Health care research & Pharmaceutical industry, seeks an Medical Devices Software Program Manager NOTE: THIS IS REMOTE ROLE & ONLY W2 CANDIDATES (NO C2C/1099) Candidate must be authorized to work in USA without requiring sponsorship Position: Medical Devices Software Program Manager(Job Id - # CFNJP00051124) Location: San Diego CA 92130 (Remote) Duration: 6 months + Contract to
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Posted 9 days ago | Updated 18 hours ago

Business Quality Assurance (BQA)

Activesoft, Inc.

•

Remote

Contract

Mandatory Skills & Qualifications: Strong knowledge in GMP, cGMP, and regulatory standards:21 CFR Part 1121 CFR Part 21021 CFR Part 211ICH Q7Experience facing FDA audits at pharmaceutical manufacturing sitesHands-on experience with manufacturing processes, CAPAs, deviations, etc.Lead Auditor or any other compliance certifications (preferred)
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Posted 25 days ago | Updated 20 hours ago

PTC Arena Consultant

Teknikoz

•

Remote

Third Party, Contract

Key Responsibilities:Lead the technical delivery of PLM solutions using PTC Windchill and Arena PLM/QMS. Guide a team of engineers and consultants across India and the USA. Configure, customize, and maintain PLM modules such as BOM, Change Management, Document Control, and Lifecycle Management. Collaborate with business stakeholders to gather requirements and design scalable PLM workflows. Oversee PLM/ERP integrations and ensure data integrity across systems. Provide mentorship, code reviews, an
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Posted 1 day ago | Updated 1 day ago

Codes & Standard Engineer

Katalyst Healthcares and Lifesciences

•

Raleigh, North Carolina, USA

Full-time

Responsibilities: Analyze design documents, specifications, and risk assessments to identify potential safety and performance issues related to device design and functionality. Participate in risk management processes, identifying potential hazards, analyzing their severity, and implementing appropriate mitigation strategies. Stay updated on regulatory changes and advise cross-functional teams on necessary adjustments to maintain compliance with applicable regulations (FDA, CE Marking, etc). De
Posted 23 days ago | Updated 1 hour ago

Regulatory Affairs - Labeling Strategy, Senior Manager

Zachary Piper Solutions, LLC

•

Raleigh, North Carolina, USA

Full-time

Piper Companies is Senior Manager for Regulatory Affairs Labeling Strategy to join the team a global biopharmaceutical company focused in neurology and immunology. In this role, you will lead labeling strategies, ensuring compliance with regulatory requirements while supporting product development and commercialization. This is a hybrid position and the ideal candidate will be located in the Atlanta, GA or Raleigh, NC regions. Responsibilities of the Labeling Strategy, Senior Manager: Develop
Posted 6 days ago | Updated 11 hours ago

Commissioning and Qualification Engineer

Katalyst Healthcares and Lifesciences

•

Raleigh, North Carolina, USA

Full-time

Responsibilities: Lead or support C&Q activities for pharmaceutical utilities and process equipment, ensuring compliance with industry standards and regulatory requirements. Execute FAT (Factory Acceptance Testing) to validate equipment functionality and performance. Support the qualification of Black and Clean utilities, such as water systems, clean steam, HVAC, and gas utilities. Perform process equipment qualification to meet GMP and production readiness standards. Develop and execute C&Q pro
Posted 23 days ago | Updated 1 hour ago

CQV Engineer

Katalyst Healthcares and Lifesciences

•

Raleigh, North Carolina, USA

Full-time

Roles & Responsibilities: Experience in Commissioning, Qualification, and Validation activities for upstream, downstream and support equipment. CQV support for all Simple Direct Impact Equipment and No Impact Equipment for all Buildings. Work with equipment and area owners from initial design, procurement, qualification (if required) to final Handover. Work with CQV Document Generation Lead in relation to generation and approval of; DQ/Design Reviews/SLIA/Test Matrices/Risk Assessments/QA Vend
Posted 23 days ago | Updated 1 hour ago

Clinical Research Coordinator

Zachary Piper Solutions, LLC

•

Raleigh, North Carolina, USA

Full-time

Piper Companies is seeking a detail-oriented and proactive Clinical Research Coordinator (CRC) to join our growing clinical research team. The ideal candidate will have hands-on phlebotomy experience and a strong background working within a clinical site network environment. This role is essential in supporting the execution of clinical trials across multiple therapeutic areas. Responsibilities for the Clinical Research Coordinator: Coordinate and manage day-to-day clinical trial activities in
Posted 11 hours ago

MES Engineer (Syncade)

Zachary Piper Solutions, LLC

•

Holly Springs, North Carolina, USA

Full-time

Piper Companies is hiring a MES Engineer (Syncade) for a biomanufacturing hub locate din Holly Springs, NC. The MES Engineer (Syncade) will be supporting the integration and configuration of Emerson DeltaV MES for two manufacturing facilities, ensuring compliance with cGMP standards and paperless workflows. The MES Engineer (Syncade) is a long term contract opportunity and will require the candidate to work on site in Holly Springs, NC 4 days per week. Responsibilities of the MES Engineer (Sync
Posted 7 days ago | Updated 11 hours ago

Medical Device System Test Engineer

Katalyst Healthcares and Lifesciences

•

Raleigh, North Carolina, USA

Full-time

Responsibilities: Develop system and subsystem-level design specifications based on requirements. Develop system and subsystem-level configurations. Develop system and subsystem-level test methods and protocols. Serve as design transfer liaison to Manufacturing, Service, Support, and Training. Serve as technical support for key products to our customers, dealers and field engineers. Prototype and test new circuit boards and improved revisions of existing circuit boards following medical de
Posted 23 days ago | Updated 1 hour ago

Environmental Monitoring Associate

Zachary Piper Solutions, LLC

•

Durham, North Carolina, USA

Full-time

Piper Companies is currently seeking a Environmental Monitoring Associate based in Durham, North Carolina for work at a leading pharmaceutical company. This is a second shift/night time opportunity--Wednesday to Saturday 4pm to 2:30am Responsibilities of the Environmental Monitoring Associate: Conduct quality walk-throughs of the production, testing and warehouse locations Collect samples relating to carbon, surface, and air testing, perform gram staining, pH and conductivity testing Ensur
Posted 11 hours ago

Environmental Monitoring Technician

Zachary Piper Solutions, LLC

•

Durham, North Carolina, USA

Full-time

Piper Companies is currently looking for an experienced Environmental Monitoring Technician in Durham, North Carolina (NC) to work for an innovative a leading pharmaceutical manufacturer. This Environmental Monitoring Technician will play an integral role in ensuring every single material inside our client's product is manufactured, processed, tested, packaged, stored and distributed aligned with their incredibly high standards of quality and meets all regulatory requirements. entry level candid
Posted 15 days ago | Updated 11 hours ago

Logistics Coordinator - Night Shift

bioMerieux

•

Durham, North Carolina, USA

Full-time

Benefits at bioMerieux: Low-cost medical, dental, and vision benefits starting day one 11 paid holidays 160 hours of paid time off Annual bonus 9.5% 401k company contribution with no vesting period Tuition reimbursement up to $10,000 per calendar year Onsite cafeteria with a daily food stipend. Position Summary & Responsibilities: The normal working hours for this role are NIGHT shift 5:00pm - 1:30am Monday - Friday. The Logistics Coordinator position is responsible for facilitating complex lo
Posted 25 days ago | Updated 15 hours ago

Engineering Manager, Life Science

Fluor

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Raleigh, North Carolina, USA

Full-time

Job Description Are you excited by working together with very talented people on projects that make make people's lives better? Do you thrive working in a multi-cultural environment where we design and build complex and challenging capital projects for our clients? We are looking for an accomplished Engineering / Design Manager for current projects in the Life Sciences market. In this position, you will lead a multidisciplinary team in the design and development of life sciences facilities fro
Posted 56 days ago | Updated 1 hour ago

Process Engineer - Associate/I

Novo Nordisk Inc

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Clayton, North Carolina, USA

Full-time

About the Department At Novo Nordisk, we are helping to improve the quality of life for millions of people worldwide. For more than 100 years, we have led the way in diabetes care. Being part of Novo Nordisk allows our employees to embark on life-changing careers, and the opportunity to help improve the quality of life for millions of people around the world. In NC, we operate three pharmaceutical manufacturing facilities that are responsible for fulfilling different steps in our injectable an
Posted 3 days ago | Updated 1 hour ago

Sr Manufacturing Maintenance Tech - Day Shift

bioMerieux

•

Durham, North Carolina, USA

Full-time

Benefits at bioMerieux: Low-cost medical, dental, and vision benefits starting day one 11 paid holidays 160 hours of paid time off Annual bonus 9.5% 401k company contribution with no vesting period Tuition reimbursement up to $10,000 per calendar year Onsite cafeteria with daily food stipend Position Summary & Responsibilities: The normal working hours for this role are anticipated to be 7:00am - 7:30pm working a 2-2-3 schedule. The Sr. Maintenance Technician is responsible for direct support
Posted 4 days ago | Updated 15 hours ago

Electrical Engineer

Eli Lilly and Company

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Durham, North Carolina, USA

Full-time

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined
Posted 25 days ago | Updated 1 hour ago

Validation Engineer I - PS AM

Novo Nordisk Inc

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Clayton, North Carolina, USA

Full-time

About the Department At Novo Nordisk, we want to make a difference. For more than 100 years, we have led the way in diabetes care. Being part of Novo Nordisk allows our employees to embark on life-changing careers, and the opportunity to help improve the quality of life for millions of people around the world. In NC, we operate three pharmaceutical manufacturing facilities that are responsible for fulfilling different steps in our injectable and oral treatment supply chains. Our Product Supply
Posted 5 days ago | Updated 1 hour ago