fda Jobs in raleigh, nc

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Validation Engineer

Indotronix International Corp

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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
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Posted 13 days ago

Engineering Manager III - Advanced Manufacturing

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 Advanced Manufacturing market. In this position, you will lead a multidisciplinary team in the design and development of advanced manufactur
Posted 9 days ago | Updated 3 hours ago

Engineering Manager II, General

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 Advanced Manufacturing, Avdanced Technology, and Life Sciences markets. In this position, you will lead a multidisciplinary team in the desi
Posted 24 days ago | Updated 3 hours ago

QC Biochemistry Lead Analyst - 3rd Shift

bioMerieux

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Durham, North Carolina, USA

Full-time

Position Summary & Responsibilities: The normal working hours for this role are anticipated to be 3rd Shift: Sunday - Thursday from 11:00pm - 7:30am. The QC Biochemistry Lead Analyst will be in a key position in the Biochemistry laboratory performing testing of Description, pH, FTIR, Osmolality, Moisture Analysis, Solubility, Loss on Drying, Resin Ratio, Reflectance, and pO2 Headspace Analysis, HPLC. This role is responsible for front-line leadership of a Quality Control team engaged in the ex
Posted 22 days ago | Updated moments ago

SAP Plant Maintenance Consultant

IT Resonance Inc.

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Remote

Contract, Third Party

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:-
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Posted 21 days ago

Regulatory Affairs - Labeling Strategy, Senior Manager (Remote)

Zachary Piper Solutions, LLC

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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. The 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 t
Posted 1 hour ago

Computer Systems Validation Engineer

Corporate Solutions General, Inc.

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Remote or San Francisco, California, USA

Full-time, Part-time, Third Party, Contract

Computer System Validation Engineer (CSV) SFO, CA Onsite Contract Client : Cellares Minimum 10+ Years experience required .5 year in Pharma domain Job Roles and Responsibilities: * Develop, execute, and document test protocols for system qualification, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). * Ensure that software is properly validated and compliant with internal and external standards, such as FDA 21 CFR Part 11, GxP, an
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Posted 2 days ago | Updated 19 hours ago

MES Consultant Remote Location

Sierra Business Solution LLC

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Remote

Contract, Third Party

MES Functional Consultant Location: Boston, MA Skill: POMSnet, PAS-X Role Description: ? 3-5 years of experience providing IT support for LIMS systems in a pharmaceutical, biotech, or laboratory setting. ? Experience with LabVantage LIMS is strongly preferred experience with LabWare LIMS also considered. ? Strong understanding of laboratory processes, sample management, and analytical workflows. ? Experience with LIMS system configuration, master data updates, and user management. ? Familiarity
Posted 3 days ago

Regulatory affairs - CMC Manager

Sureminds Solutions

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Remote

Contract

Title : Regulatory affairs - CMC Manager Location: Remote This will be 100% remote in the US only 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 su
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Posted 7 days ago

Solution Architect with Pharma & Regulatory Experience

The Dignify Solutions, LLC

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Remote or Raritan, New Jersey, USA

Contract, Third Party

Architect and design IT solutions tailored to global Regulatory Affairs functions, including submissions, registration tracking, labeling, and IDMP compliance. Develop and guide implementation of GenAI solutions (e.g., document summarization, narrative generation, intelligent labeling) for regulatory use cases. Lead end-to-end architectural governance for regulatory systems, including integrations with RIM, DMS, and Health Authority gateways. Design and optimize Cloud-native data pipelines for r
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Posted 14 days ago | Updated 10 hours ago

IT Database/System Administrator

Javen Technologies, Inc

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Remote

Contract

Title: IT Database/System Administrator Location: Remote Duration: 12 Months contract Job Details: Minimal work direction needed, highly skilled and knowledgeable to the position and provides best practicing sharing within work group. Responsible for the maintenance, troubleshooting, access, and backup for enterprise-wide systems. Technologies supported include operating systems, servers, networks, system security, hardware and other software applications. Two (2) years experience working with
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Posted 22 hours ago | Updated 22 hours ago

Computer System Validation Specialist

SGS Consulting

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Remote

Contract

Job Title: Computer System Validation (CSV) Specialist Duration: 08 Months + (Possible Extension) Location: Wilmington, DE 19803 (Remote) Schedule: M-F: 08 AM 05 PM Kindly Do not apply if you are not or Permanent Resident of USA. Qualifications: The official position title is Computer System Validation (CSV) specialist to support the Newark manufacturing facility with validation of new and existing computerized systems.This role will primarily support the Newark manufacturing facility but may r
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Posted 15 days ago

Clinical Research Associate (CRA)

Zachary Piper Solutions, LLC

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Remote

Full-time

Piper Companies is seeking a Clinical Research Associate (CRA) with experience in Oncology clinical trials to join a reputable clinical research organization. This is a full-time/permanent opportunity. Some travel is required (regionally, about 8-10 days out of the month). Candidates must be located in CST or PST in one of the following states: WY, CO, KS, WI, IN, OH, MN, MO, IL, MI, KY, AR, CA, OR, WA, NV, UT, AZ. Responsibilities of the Senior Clinical Research Associate (CRA): Perform site s
Posted 6 days ago | Updated 1 hour ago

Appian Developer - Remote!

General Dynamics

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Remote

Full-time

Type of Requisition: Regular Clearance Level Must Currently Possess: None Clearance Level Must Be Able to Obtain: None Public Trust/Other Required: Other Job Family: Software Development Job Qualifications: Skills: Appian (Platform), Appian BPM, Appian Process Automation Certifications: None Experience: 5 + years of related experience ship Required: No Job Description: General Dynamics Information Technology is seeking numerous candidatesto fill multiple-level Appian Developer roles on a
Posted 1 day ago | Updated 3 hours ago

Sr. R&D Engineer

Medtronic

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Remote or Irvine, California, USA

Full-time

We anticipate the application window for this opening will close on - 24 Jun 2025 Position Description: Sr. R&D Engineer for Covidien, LP (a Medtronic company) located in Irvine, CA. Multiple positions available. Responsible for providing R&D and quality engineering support to ensure the successful development of Medtronic Neurovascular devices, design transfers, scale-up and ongoing operational support; work with Design and Quality control of Class II and Class medical devices (bare-metal or
Posted 15 days ago | Updated 3 hours ago

UX Writer

Beacon Systems, Inc

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Remote

Contract, Third Party

About Beacon Systems, Inc Beacon Systems, Inc, delivers Program Management, Science, Engineering, and Technology Solutions to Federal, Commercial, State, and Local Agencies. We are a subsidiary of Radiant Digital Solutions. Our Technology support to many DoD Agencies, NASA, Voice of America, FDA, and State Agencies such as State of FL, RI, MS, ND, VA, and WV extends our delivery of solutions worldwide. Position Title: Hybrid UX Designer / UX Writer Duration: Long Term Location: Remote- Orlando,
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Posted 7 days ago | Updated 1 day ago

MES Consultant

BOTG LLC

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Remote

Full-time

Location: Remote Job Type: Full-Time / Contract Industry: Life Sciences / Pharmaceuticals / Manufacturing About the Role: We are seeking experienced MES (Manufacturing Execution System) Consultants with strong backgrounds in Electronic Batch Records (EBR) and Master Batch Record (MBR) design, along with hands-on recipe authoring experience. This is a remote position, ideal for professionals with a solid understanding of GMP-regulated environments, especially in pharmaceutical or biotech manufact
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Posted 3 days ago

Clinical Research Associate

Zachary Piper Solutions, LLC

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Remote

Full-time

Piper Companies is seeking a Clinical Research Associate (CRA) with experience in Oncology clinical trials to join a reputable clinical research organization. This is a full-time/permanent opportunity. Some travel is required (regionally, about 8-10 days out of the month). Candidates must be located in CST or PST in one of the following states: WY, CO, KS, WI, IN, OH, MN, MO, IL, MI, KY, AR, CA, OR, WA, NV, UT, AZ. Responsibilities of the Senior Clinical Research Associate (CRA): Perform site s
Posted 23 days ago | Updated 1 hour ago

Senior UX Designer (Hospitality, Travel, or Entertainment)

Beacon Systems, Inc

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Remote

Third Party, Contract

About Beacon Systems, Inc Beacon Systems, Inc, delivers Program Management, Science, Engineering, and Technology Solutions to Federal, Commercial, State, and Local Agencies. We are a subsidiary of Radiant Digital Solutions. Our Technology support to many DoD Agencies, NASA, Voice of America, FDA, and State Agencies such as State of FL, RI, MS, ND, VA, and WV extends our delivery of solutions worldwide. Position: Senior UX Designer Location: Remote - Orlando FL Duration: Long Term Summary: We are
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Posted 1 day ago

Senior UX Designer

Beacon Systems, Inc

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Remote

Contract

Beacon Systems, Inc, delivers Program Management, Science, Engineering, and Technology Solutions to Federal, Commercial State, and Local Agencies. We are a subsidiary of Radiant Digital Solutions. Our Technology support to many DoD Agencies, NASA, Voice of America, FDA, and State Agencies such as State of FL, RI, MS, ND, VA, and WV extends our delivery of solutions worldwide. We are looking for a Senior UX Designer - Remote Request you to make sure your updated Resume highlights all the below-me
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Posted 7 days ago | Updated 15 hours ago