FDA Jobs in Raleigh, NC

Refine Results
1 - 20 of 79 Jobs

Regulatory affairs - CMC Manager

Sureminds Solutions

•

Remote

Full-time

PREREQUISITES BS/BA degree in Scientific Discipline (Masters or higher preferred) with 5+ years in the pharmaceutical industry, preferably with 3+ years CMC regulatory experience, Sterile Injectable experience preferred. Responsibilities will include, but are not limited to, the following: 1. Participate in the development of the CMC regulatory strategy for post-approval small molecule product submissions, including global supplements/variations and responses to health authority queries. 2. Prep
Easy Apply
Posted 2 days ago

SAP Plant Maintenance (SAP PM)

IT Resonance Inc.

•

Remote

Contract, Third Party

SAP Plant Maintenance (SAP PM) 12 months Remote with travel to onsite (Chicago IL) Must have food & beverage manufacturing or consumer packaged goods industry experience Solid/Strong comm skills compliance with food industry standards (e.g., FDA, GMP, HACCP) Regards Stephen DJA stephen at itresonance dot com
Easy Apply
Posted 16 days 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
Easy Apply
Posted 25 days ago | Updated moments ago

Systems Engineer

Mindlance

•

Remote

Contract

Job Description: Must-Haves: 1. Configuration Management Expertise: Proven understanding and application of configuration management principles and best practices within a complex product development environment. 2. Medical Device Experience: Experience working within the medical device industry or other regulated sectors with knowledge of FDA regulations and ISO standards. 3. Jama Connect Proficiency: Hands-on experience using Jama Connect tool to manage requirements management and traceability
Easy Apply
Posted 60+ days ago | Updated 1 day ago

Consultant, XRPD for Solid Oral dosage, GI

Eliassen Group

•

Anywhere, US

Contract

Description: *Remote role* Our F500 Pharma Client is seeking a consultant with strong technical XRPD expertise in solid oral dosage tablet for NDA readiness. We can facilitate w2 and corp-to-corp consultants. For our w2 consultants, we offer a great benefits package that includes Medical, Dental, and Vision benefits, 401k with company matching, and life insurance. Rate: $190 - $200 / hr. w2 Experience Requirements: Pharmaceutical Drug Development Experience Solid Oral Dosage Experience Str
Posted 50 days ago | Updated 1 hour 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 23 hours ago | Updated 11 hours ago

Deviation Management Specialist

Zachary Piper Solutions, LLC

•

Durham, North Carolina, USA

Full-time

Piper Companies is currently seeking a Deviation Management Specialist based in Durham, NC for work at a leading pharmaceutical company. The Deviation Management Specialist will play an integral role in conducting manufacturing/QC deviation investigations, authoring investigations as well as resolutions Responsibilities of the Deviation Management Specialist: Lead Quality Control and manufacturing operation deviation investigations Conduct interviews with QC and manufacturing personnel working
Posted 4 days ago | Updated 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 4 days ago | Updated 11 hours ago

Commissioning Qualification Validation Engineer

Zachary Piper Solutions, LLC

•

Durham, North Carolina, USA

Full-time

Piper Companies is currently looking for an experienced Commissioning Qualification Validation Engineer (CQV) in Raritan, New Jersey (NJ) to work for an innovative and growing pharmaceutical manufacturer. Responsibilities for the Commissioning Qualification Validation Engineer (CQV) include: Commissioning: Lead commissioning activities for new laboratory equipment, systems, and facilities, ensuring they are installed and function as intended. Qualification: Develop, execute, and document qualif
Posted 4 days ago | Updated 11 hours ago

RN Clinical Research

UNC Health Care

•

Raleigh, North Carolina, USA

Full-time

Job Description Description Become part of an inclusive organization with over 40,000 teammates, whose mission is to improve the health and well-being of the unique communities we serve. Summary: Provides education and communication on clinical research activities and ensures compliance for all studies by following protocols and procedures. Responsibilities: 1. Review research protocols to determine availability of resources, subjects and equipment needs. 2. Educates patients and families abou
Posted 1 day ago | Updated 3 hours ago

Engineering Manager, Life Science

Fluor

•

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 22 days ago | Updated 2 hours ago

Associate Process Engineer - API

Novo Nordisk Inc

•

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 1 day ago | Updated 2 hours ago

Validation Engineer

Indotronix International Corp

•

Durham, North Carolina, USA

Full-time

Role: Validation Engineer Location: Durham, NC Pay Rate: $40/Hr on W2 Duration:6+ Months Scope of Position: Reporting directly to the Quality Engineering Supervisor, this position involves product team support for the manufacturing operations, provides quality guidance, product resolution decisions, and statistical problem-solving techniques to manufacturing operations and projects teams for new product introduction, process improvements, continuous improvements, and validation activities. This
Easy Apply
Posted 8 days ago

Engineering Manager III - Advanced Manufacturing

Fluor

•

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 Advanced Manufacturing market. In this position, you will lead a multidisciplinary team in the design and development of advanced manufactur
Posted 4 days ago | Updated 2 hours ago

Process Engineer, Associate/I- API (12hr Night Shift)

Novo Nordisk Inc

•

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 32 days ago | Updated 2 hours ago

Engineering Manager II, General

Fluor

•

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 Advanced Manufacturing, Avdanced Technology, and Life Sciences markets. In this position, you will lead a multidisciplinary team in the desi
Posted 19 days ago | Updated 2 hours ago

Sr Full Stack Engineer

Pinnacle Software Solutions

•

Remote

Contract

KFORCE URGENT REQUIREMENT Looking for candidates regarding the following: POSITION Sr Full Stack Engineer LOCATION Remote DURATION 6+ months INTERVIEW TYPE Video VISA RESTRICTIONS None REQUIRED SKILLS 5+ years of experience working in a SaaS-based product development environment or FDA-regulated medical device environmentExperience with programming languages Java, JavaScript, and SQLMust have SaFE Agile framework experienceSpring BootAngular
Easy Apply
Posted 1 day ago | Updated 1 day ago

SAP Plant Maintenance Consultant

IT Resonance Inc.

•

Remote

Third Party, Contract

Hi, Here is an Remote Contract Job opportunity for below position. Role: SAP Plant Maintenance (PM) Consultant Location: IL, Remote + (Occasional Travel) Contract Duration: 12+ Months Experience: 10 + Year skills compliance with food industry standards (e.g., FDA, GMP, HACCP) Regards, Nirmal Kumar Phone:- Email:-
Easy Apply
Posted 16 days ago

Regulatory Affairs - Labeling Strategy, Senior Manager (Remote)

Zachary Piper Solutions, LLC

•

Remote or Atlanta, Georgia, 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 preferred candidate will be located in the Atlanta, GA or Raleigh, NC regions, however candidates outside of these regions will be considered as well. Responsibilities of
Posted 1 day ago | Updated 11 hours ago

Sr. Full Stack Engineer (Remote)

Pinnacle Software Solutions

•

Remote

Contract

Position: Sr. Full Stack Engineer Location: Remote Duration: 6+ Months (Contract) Job Overview: We are seeking a Sr. Full Stack Engineer to join our growing team and contribute to the development of cutting-edge SaaS solutions. This is a fully remote role ideal for experienced engineers with a strong background in Java, JavaScript, and SQL, and who are comfortable working in fast-paced, Agile-driven environments. Candidates with experience in FDA-regulated medical device development or SaaS prod
Easy Apply
Posted 1 day ago | Updated 1 day ago