Good manufacturing practice Jobs in Raleigh, NC

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Senior CQV Engineer

Zachary Piper Solutions, LLC

Raleigh, North Carolina, USA

Full-time

Piper Companies is actively seeking a Senior CQV (Commissioning, Qualification, and Validation) Engineer to join our team. The ideal candidate will have 7-10 years of CQV experience with large-scale process equipment, including upstream, downstream, and CIP (Clean-In-Place) systems. This role is critical to ensuring the successful commissioning and validation of our biopharmaceutical manufacturing processes. This is a Monday - Friday, traditional hours role located in the greater Raleigh, NC are

Process Engineer - Upstream

Amgen Inc

Holly Springs, North Carolina, USA

Full-time

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

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

Manufacturing Associate

Zachary Piper Solutions, LLC

Durham, North Carolina, USA

Full-time

Piper Companies is seeking a Manufacturing Associate for an onsite contract position in Durham, North Carolina (NC). The Manufacturing Associate will be responsible for overseeing the creation and management of batch records to ensure the efficient operation of equipment and processes as well as supporting regular manufacturing operations and scaling of cGMP manufacturing. Responsibilities of the Manufacturing Associate include: Full GMP training program with classroom and hands-on shadowing w

Associate Scientist (Environmental Monitoring)

Zachary Piper Solutions, LLC

Durham, North Carolina, USA

Full-time

Piper Companies is seeking an Associate Scientist (Environmental Monitoring) to fill an opportunity with an innovative Pharmaceutical company in Durham, NC. Responsibilities for the Associate Scientist (Environmental Monitoring) Provide environmental monitoring support to manufacturing and laboratory groups Support water sampling, and pH water testing Clean steam and compressed gas sample collection Maintain laboratory material and reagent inventory Analyze environmental monitoring data and comp

Validation Specialist

Zachary Piper Solutions, LLC

Clayton, North Carolina, USA

Full-time

The Validation Specialist join a leading global pharmaceutical company that is rapidly expanding its international presence, with plans to double in both size and production in the coming years. The Validation Specialist will be responsible for executing and reviewing revalidations, ensuring compliance with regulatory standards, and collaborating with cross-functional teams to support validation protocols and investigations. This role is essential in maintaining the accuracy of validation proces

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

Senior Engineer, Projects

Amgen Inc

Holly Springs, North Carolina, USA

Full-time

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

Mechanical Services Engineer (2nd shift)

Merck & Company Inc

Durham, North Carolina, USA

Full-time

Job Description The Mechanical Services Engineer position will ensure the reliable performance of equipment by providing hands-on maintenance support for complex troubleshooting and repairs of equipment, as well as supporting Technology and Quality during equipment investigations and modifications. The successful candidate will be responsible for aligning maintenance projects with the business objectives around Safety, Compliance and Cost. The Mechanical Services Engineer must be able to self-i

Sr Manufacturing Maintenance Tech - 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 daily food stipend Position Summary & Responsibilities: The normal working hours for this role are anticipated to be 7:00pm - 7:30am working a 2-2-3 schedule. The Sr. Maintenance Technician is responsible for direct support

Senior Mechanical Services Engineer (2nd shift)

Merck & Company Inc

Durham, North Carolina, USA

Full-time

Job Description The Senior Mechanical Services Engineer position will ensure the reliable performance of equipment by providing hands-on maintenance support for complex troubleshooting and repairs of equipment, as well as supporting Technology and Quality during equipment investigations and modifications. The successful candidate will be responsible for aligning maintenance projects with the business objectives around Safety, Compliance and Cost. The Senior Mechanical Services Engineer must be

Manufacturing Tech 2, Line 4 - Night Shift (D)

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: Normal working hours: 7:00pm - 7:30am working a 2-2-3 rotation schedule. The Process Technician position is responsible for the operation of high-speed equipment used in

Spclst, Engineering

Merck & Company Inc

Remote or Durham, North Carolina, USA

Full-time

Job Description Durham's Technical Operations Specialist will be an energetic, technical leader with strong interpersonal, communication, and collaboration skills responsible for implementation of technology transfer process knowledge, license approval support, commercial process enhancement activities, and routine support of commercial manufacturing. This position will primarily support the upstream fermentation and downstream purification processes for the technology transfer of our HPV vacc

Director, Process Development - Drug Substance Technologies

Amgen Inc

Holly Springs, North Carolina, USA

Full-time

Career Category Scientific 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 each

Senior Engineer Fire & Life Safety

Amgen Inc

Holly Springs, North Carolina, USA

Full-time

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

Senior Specialist, Engineering

Merck & Company Inc

Remote or Durham, North Carolina, USA

Full-time

Job Description Durham's Technical Operations Senior Specialist will be an energetic, technical leader with strong interpersonal, communication, and collaboration skills responsible for implementation of technology transfer process knowledge, license approval support, commercial process enhancement activities, and routine support of commercial manufacturing. This position will primarily support the upstream fermentation and downstream purification processes for the technology transfer of our H

Senior Process Engineer - Clean Utilities - Design Specialist

Amgen Inc

Holly Springs, North Carolina, USA

Full-time

Career Category Engineering Job Description 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 millio

Associate Director, Engineering

Merck & Company Inc

Durham, North Carolina, USA

Full-time

Job Description GENERAL SUMMARY The Engineering, Maintenance and Site Services (EMSS) organization continuously improve the reliability of the Durham Site operations and provides the best in class services with the final goal of delivering our high-quality vaccines to the patients around the world With our core principle of Safety First and Quality Always EMSS strives to have the safest and most compliant operation around the network. EMSS has an Associate Director opening for the Vaccine Ma

MODA ES EBR SME

Bytecubit Technologies

Remote

Contract

Job Title: MODA ES EBR SMELocation: RemoteDuration: 12+ monthsPay Rate: 60/hr-80/hr (depending on experience)Job Description:Seeking an SME of MODA ES EBR Execution Systems to bridge the gap for the sites MODA module.Resource will act as an owner s rep for the master data control and support the integration of the CGMP ES systems and analytical equipment.Will oversee configuration and data capture to provide quality data flow for the site.Will be involved in training of analysts in LIMS MODA, a

Sr. Spclst, Engineering Electrical Utilities

Merck & Company Inc

Durham, North Carolina, USA

Full-time

Job Description The Sr, Electrical Engineer Utilities is a member of the Plant Engineering team providing technical support to the Durham Site. The site includes an Energy Center, Vaccines DP and DS Manufacturing Facilities, Quality Labs, various other manufacturing buildings and Maintenance and Material Storage Facility (MMSF). This support position will focus on leading investigation of Electrical system excursions, engineering maintenance, design system improvements and optimizations. This i