Good Manufacturing Practice jobs in Durham, NC

Durham, North Carolina

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Today

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 wil

Full-time

Process Engineer

Raleigh, North Carolina

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Today

Full-time

Metrology Technician III

Durham, North Carolina

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Today

Position Overview Perform general Metrology repairs/troubleshooting/preventive maintenance to all plant equipment/systems, process measurement and control, utility, laboratory, and bench-top instrumentation. Perform routine scheduled calibration. Company Overview At FUJIFILM Biotechnologies, we're leading the charge in advancing tomorrow's medicines. If you want to be a part of life-impacting projects alongside today's most innovative biopharmaceutical companies, FUJIFILM Biotechnologies coul

Full-time

Process Engineer 2, Visual Inspection

Holly Springs, North Carolina

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Today

Position Overview The Process Engineer 2 that supports Drug Product Finished Goods (DPFG) within the assigned area(s) [Visual Inspection] provides engineering guidance to stakeholders throughout the organization to support capital projects, technology transfer, and manufacturing operations while ensuring processes are efficient, scalable, compliant with Current Good Manufacturing Practice (CGMP) regulations. This role adheres to product and customer requirements and works toward optimizing plan

Full-time

Senior Validation Engineer

Durham, North Carolina

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Today

Job Description PSC Biotech provides the life sciences with essential services to ensure that health care products are developed, manufactured, and distributed to the highest standards, in compliance with all applicable regulatory requirements. Our goal is to skyrocket our clients' success, and you can be a part of our team's achievements. Employing a global team of skilled professionals and experts that span across strategically located offices in North America, Europe, Asia and the Middle East

Full-time

Computer System Validation Engineer

Raleigh, North Carolina

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Today

Job Description: We are seeking a Computer System Validation (CSV) Engineer for a global pharmaceutical client. This role will work cross-functionally to lead and execute validation activities for GxP electronic systems and applications. The CSV Engineer will partner with Business Owners, Technical Owners, and Quality teams to create and manage validation deliverables throughout the validation lifecycle. The primary responsibility is to ensure that validation activities supporting Manufacturing

Full-time

Digital Tech Specialist

North Carolina

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Today

Digital & Technology Specialist On-Site Role Compensation: $50 - $60 ABOUT THE ROLE Our client is seeking a Digital & Technology Specialist to support both site and global digital transformation initiatives by delivering robust technical solutions, maintaining and improving operational technology, and ensuring compliance with cGMP, EHS, and quality requirements. This role serves as both an individual contributor and a technical lead on projects, driving continuous improvement and operational

Contract

$50.00 - $60.00

Automation Engineer 2, BMS/VDS

Holly Springs, North Carolina

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Today

Position Overview The Automation Engineer 2, BMS/VDS provides support for the sitewide Building Management System (BMS) and Validated Data System (VDS). This includes implementation of changes to the utility and facility automation systems, updating design documents, executing testing, troubleshooting events, and providing on-call support. This role participates in and may lead projects and medium- to complex-level changes while coordinating with internal and external stakeholders. Company Ove

Full-time

Automation Engineer 3, BMS/VDS

Holly Springs, North Carolina

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Today

Position Overview The Automation Engineer 3, BMS/VDS provides support for the sitewide Building Management System (BMS) and Validated Data System (VDS). This includes implementation of changes to the utility and facility automation systems, updating design documents, executing testing, troubleshooting events, and providing on-call support. This role participates in and may lead projects and medium- to complex-level changes while coordinating with internal and external stakeholders. Company Ove

Full-time

Process Engineer 1

Holly Springs, North Carolina

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Today

Position Overview The Process Engineer 1 will provide engineering guidance to support capital projects, technology transfer, and manufacturing operations. This will ensure compliance with all safety, regulatory, and engineering requirements. This role will adhere to product and customer requirements, and work towards optimizing plant efficiency and profitability. Company Overview FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. By end of 2025,

Full-time

Engineer 2, Black Utilities

Holly Springs, North Carolina

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Today

Position Overview The Engineer 2, Black Utilities provides engineering support to field personnel in the performance of maintenance and operational tasks associated with Black Utilities, including HVAC systems, Chilled Water Systems, Steam Boilers, Cooling Towers, HVAC and Glycol Chiller and Compressed Air Systems. This role works directly with other Utility Engineers to ensure applicable safety and regulatory standards are maintained, identify process improvements, and assist with troubleshoot

Full-time

Engineer 3, DPFG MSAT

Holly Springs, North Carolina

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Today

Position Overview The Manufacturing Science and Technology (MSAT) Engineer 3 provides technical leadership across current good manufacturing practice (cGMP) manufacturing, delivering end-to-end support for scale-up, process validation, continued process verification, and continuous improvement. This role drives technology transfer (TT) of new and existing drug product processes into and between sites, ensuring robust process fit, compliant documentation, and readiness through close collaboratio

Full-time

Engineer 2, Instrumentation & Controls

Holly Springs, North Carolina

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Today

Position Overview The I&C Engineer provides engineering support to field personnel in the performance of maintenance and operational tasks associated with instrumentation and automation systems and controls across the campus. The I&C Engineer provides support for the metrology department through evaluations of instrument deficiencies, test equipment issues and calibration strategies and methods. This role works directly with other Utility Engineers ensuring applicable safety and regulatory stan

Full-time

Process Analytical Engineer

Holly Springs, North Carolina

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Today

Career Category Manufacturing Job Description Join Amgen's Mission of Serving Patients At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients e

Full-time

USD 88,281.00 - 119,439.00 per year

Process Engineer - Solution Prep, Upstream, and Downstream

Holly Springs, North Carolina

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Today

Career Category Engineering Job Description Join Amgen's Mission of Serving Patients At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients eac

Full-time

USD 88,281.00 - 119,439.00 per year

Senior Process Engineer - Solution Prep, Upstream, and Downstream

Holly Springs, North Carolina

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Today

Full-time

USD 115,494.60 - 156,257.40 per year

Senior Director, Technology and Life Sciences

Raleigh, North Carolina

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Today

McGough is a respected partner that brings six generations of experience to high profile, unique and complex construction projects. We take great pride in our people and their extraordinary expertise in planning, development, construction and facility management. McGough employee tenure reflects the commitment and pride we share in our work. Ask anyone who knows us - the caliber of our people sets us apart. SENIOR DIRECTOR, TECHNOLOGY & LIFE SCIENCES The Senior Director, Technology & Life Scie

Full-time

USD 178,100.00 - 237,400.00 per year

Process Engineer

Raleigh, North Carolina

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Today

Process Engineer At Salas O'Brien we tell our clients that we're engineered for impact. This passion for making a difference applies just as much to our team as it does to our projects. That's why we are committed to living our values every day: inspiring, achieving, and connecting as shared owners of our success with a focus on a sustainable future. Building for the long-term means that all our team members can expect to work on amazing projects with a people-first approach to problem solving

Full-time

CQV Engineer

Remote or New Jersey

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Today

Summary : This position will be responsible for providing Commissioning, Qualification and Validation support to the cGMP Clinical and Commercial Cell Therapy Manufacturing plant. This individual will be responsible in handling day-to-day activities inclusive of execution, protocol management, vendor management, issues, deviations, corrections and remediation efforts for facility, equipment, systems and processes in support of personalized cell therapy production through safe and compliant manuf

Full-time

Engineer Pharma Validation

Remote

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Today

Job Summary Responsible for the validation of facility utilities, equipment processes and cleaning for cGMP products such as pharmaceuticals, medical devices, and cosmetic products to adhere to 21 CFR 211/210, 21 CFR 820, and other applicable regulatory requirements. Assist in authoring and executing protocols to demonstrate that manufacturing and cleaning processes are executed with consistent quality and results within a controlled environment. Responsible for managing and or performing reval

Full-time

USD 73,000.00 - 110,000.00 per year

Good Manufacturing Practice jobs in Durham, NC, USA