FDA Jobs in North Carolina

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Process Validation Staff Engineer

Thermo Fisher Scientific

Greenville, North Carolina, USA

Full-time

Work Schedule Other Environmental Conditions Office Job Description As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for

Manufacturing Systems Lead

Hallmark Global Technologies

Winston-Salem, North Carolina, USA

Third Party, Contract

Title: Manufacturing Systems Lead Location: Onsite/Hybrid at Winston Salem, NC (3-5 days/week) Rate: Open Duration: 6 Months plus extension Role/Responsibilities: Lead implementation and support of site GMP manufacturing systems Lead automation of site manufacturing operations Lead implementation of data acquisition and analytics platform in support of site manufacturing Provide Industry 4.0 vision for digitalization of manufacturing Providing day-to-day expertise to manufacturing operations f

Quality Assurance Specialist Document Control

HAYS

North Carolina, USA

Full-time

Are you looking for a QA Specialist role? Check out this new role in the pharmaceutical space POSITION SUMMARY: Under the direction of the QA Document Control Supervisor, the QA Systems Associate - Document Control will Be responsible for searching, reviewing, comparing and verifying data using Excel spreadsheet, Master Control, and SAP OpenText. This individual will work closely with the IT Validation team for the purpose of data review and for Migration process. This individual will have wo

Quality System Specialist

HAYS

North Carolina, USA

Full-time

We're looking for a Quality System specialist. POSITION SUMMARY: Under the direction of the QA Document Control Supervisor, the QA Systems Associate - Document Control will Be responsible for searching, reviewing, comparing and verifying data using Excel spreadsheet, Master Control, and SAP OpenText. This individual will work closely with the IT Validation team for the purpose of data review and for Migration process. This individual will have working knowledge of the document management life

Manager, Manufacturing Engineering

Thermo Fisher Scientific

High Point, North Carolina, USA

Full-time

Job Description When you join us at Thermo Fisher Scientific, you'll be part of an inquisitive team that shares your passion for exploration and discovery. With revenues of more than $40 billion and the largest investment in R&D in the industry, we give our people the resources and chances to create significant contributions to the world. Location: This position will be based at our High Point, NC facility. Discover Impactful Work: The Manager of Manufacturing Engineering will be responsible

Utilities Process Engineer

Zachary Piper Solutions, LLC

Raleigh, North Carolina, USA

Full-time

Piper Companies is actively seeking a Utilities Process Engineer to join a global pharmaceutical organization that looks to provide solutions for chronic diseases. The Utilities Process Engineer will support new projects, equipment, and utilities throughout an API facility. The ideal candidate will have mechanical troubleshooting abilities in a production environment. This will be a Monday - Friday, 8:00 - 4:30 PM position in the Raleigh, NC area. Responsibilities of the Utilities Process Engine

Senior Regulatory Affairs

Thermo Fisher Scientific

High Point, North Carolina, USA

Full-time

Job Description When you join us at Thermo Fisher Scientific, you'll be part of a hard-working and driven team that shares your passion for exploration and discovery. With revenues of approximately $40 billion and the largest investment in R&D in the industry, we give our people the resources and chances to create significant contributions to the world. Ranked #69 on the 2023 Fortune 500 list, you'll discover endless opportunities to grow a rewarding career as part of the world leader in servin

Manager, Technical Services and Validation

Thermo Fisher Scientific

High Point, North Carolina, USA

Full-time

Job Description As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world's toughest challenges, like protectin

MES Consulting Engineer

Zachary Piper Solutions, LLC

Cary, North Carolina, USA

Full-time

Do you have a passion for optimizing manufacturing processes in the pharmaceutical industry? Are you an expert in PAS-X systems? If so, we want to hear from you! We are seeking a highly motivated MES Engineer to join our team and play a key role in the design and implementation of a PAS-X system for our state-of-the-art drug product and finished goods facility. Responsibilities: Collaborate with internal stakeholders to define MES requirements and develop User Requirement Specifications (URS)

Process Development Senior Associate

Amgen Inc

North Carolina, USA

Full-time

HOW MIGHT YOU DEFY IMAGINATION? You've worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared mission-to serve patients-drives all that we do. It is key to our becoming one of the world's leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in thi

Process Development Senior Scientist

Amgen Inc

North Carolina, USA

Full-time

HOW MIGHT YOU DEFY IMAGINATION? You've worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared mission-to serve patients-drives all that we do. It is key to our becoming one of the world's leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in thi

QA Manager

Danaher Corporation

Durham, North Carolina, USA

Full-time

For over 170 years, Leica Microsystems has helped shape the future by developing groundbreaking optical and digital solutions. As a global leader, we're driven by continuous improvement to excite our customers and to create the best work environment for our people. Customer focus, innovation, and teamwork are at the core of our culture and the foundation of our success. Leica Microsystems is one of the market leaders in the fields of microscopy, imaging, and analysis. We reveal the invisible an

Technical Sourcing Engineer III - Electrical (onsite)

Thermo Fisher Scientific

Asheville, North Carolina, USA

Full-time

Job Description Job Title: Technical Sourcing Engineer - Electrical Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. How

Sr. Software Designer (C++) - ONLY W2

BayOne Solutions

Raleigh, North Carolina, USA

Contract

Title Sr. Software Designer (C++) Raleigh, NC. Work shift (days/times) Onsite - Monday to Friday - 8:00 AM - 5:00 PM 3 Months Contract Pay: $65 - $75/hr. on W2. (Only W2, No C2C/1099) Requirement: Architecting Host Software (C++), WPF, .NETDesign and development of embedded software for the legacy and new generation of the medical device (C and C++).Responsible for design and development of software tools to support manufacturing the medical device (C, C# and C++)Write software requirements fo

MES System Consultant/Administrator

Hallmark Global Technologies

Winston-Salem, North Carolina, USA

Third Party, Contract

Title: MES System Consultant/Administrator Location: Onsite/Hybrid at Winston Salem, NC (3-5 days/week) Rate: Open Duration: 6 Months plus extension Role/Responsibilities: Experienced with design, implementation, and support of Manufacturing Execution System (MES) and/or Electronic Batch Records (EBRs) Providing day-to-day expertise to manufacturing operations for use of EBRs Managing vendors to troubleshoot system issues and functionality Escalate and ensure closure of all production issues re

Software Test Engineer

Digital Prospectors

Raleigh, North Carolina, USA

Contract

Position: Software Test Engineer Location: Raleigh, NC (Onsite) Length: 6+ months Job Description: Our client is seeking a Software Test Engineer who will lead the design and execution of comprehensive test plans for medical device software. The Software Test Engineer will ensure the reliability, security, and performance of software across various platforms, all while adhering to regulatory standards. The Software Test Engineer will collaborate closely with cross-functional teams to deliver hig

Sr Embedded Engineer

Info Way Solutions

Raleigh, North Carolina, USA

Contract, Third Party

Role: Software Designer Sr(Embedded Engineer) Location :Raleigh, NC (Onsite) Architecting Host Software (C++), WPF, .NET Design and development of embedded software for the legacy and new generation of the medical device (C and C++). Responsible for design and development of software tools to support manufacturing the medical device (C, C# and C++) Write software requirements for the host application and software tools Provide design input for GUI of system software Ensure FDA compliance of all