GMP Jobs in Raleigh, NC

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Specialist Quality Control

TEKsystems c/o Allegis Group

Apex, North Carolina, USA

Full-time

Job Title: QC Laboratory Systems Specialist (ELN Project Support) Location: Apex, NC About the Role We are seeking a highly motivated and experienced QC Laboratory Systems Specialist to support the implementation and validation of electronic quality systems, with a focus on the QC ELN Project. This role is ideal for someone with a strong experience in computerized laboratory systems, excellent leadership skills, and the ability to work independently in a GMP-regulated environment. Key Responsi

Commissioning and Qualification Engineer

Katalyst Healthcares and Lifesciences

Raleigh, North Carolina, USA

Full-time

Responsibilities: Lead or support C&Q activities for pharmaceutical utilities and process equipment, ensuring compliance with industry standards and regulatory requirements. Execute FAT (Factory Acceptance Testing) to validate equipment functionality and performance. Support the qualification of Black and Clean utilities, such as water systems, clean steam, HVAC, and gas utilities. Perform process equipment qualification to meet GMP and production readiness standards. Develop and execute C&Q pro

CQV Engineer

Katalyst Healthcares and Lifesciences

Holly Springs, North Carolina, USA

Full-time

Responsibilities: Upstream/downstream process and CQV support (ex. autoclaves, parts washers, incubators, Isolators, HVAC). Managing and working collaboratively with clients' quality representative to complete deviation investigation and resolution for problems and issues encountered during execution activities. Includes ability to complete root cause analysis. Supporting clients change management program - including authoring proposed changes, executing impact assessments/ regression analysis,

Field Service Engineer- FIELD BASED (Greensboro, NC)

Becton Dickinson & Company

Raleigh, North Carolina, USA

Full-time

Job Description Summary Job Description We are the makers of possible BD is one of the largest global medical technology companies in the world. Advancing the world of health is our Purpose, and it's no small feat. It takes the imagination and passion of all of us-from design and engineering to the manufacturing and marketing of our billions of MedTech products per year-to look at the impossible and find transformative solutions that turn dreams into possibilities. We believe that the human e

Sr Manufacturing Tech - 2nd Shift

bioMerieux

Durham, North Carolina, USA

Full-time

Position Summary & Responsibilities: The normal working hours for this role are anticipated to be 2nd shift: Monday - Friday from 3:00pm - 11:30pm. The Sr Manufacturing Technician position is responsible for the operation of high speed equipment used in the production and packaging of BacT/ALERT bottles in a cGMP compliant manner. ProductionOperate and maintain highly automated bottle handling, filling, vision inspection, conveying, robotic palletizing, autoclaving, labeling and / or process ba

Senior Engineer (Site Mechanical)

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

Sr. Spclst, Engineering

Merck & Company Inc

Durham, North Carolina, USA

Full-time

Job Description Join our dynamic Engineering, Maintenance, & Utility Department as a Senior Specialist, where you will play a crucial role in enhancing asset reliability and driving manufacturing excellence in a fast-paced environment. Utilize your engineering expertise and leadership skills to empower teams, solve complex technical challenges, and ensure compliance with industry standards while making a tangible impact on our operational success. Our Manufacturing Operations teams are the peo

Process Engineer - Upstream Equipment

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 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

Process Engineer

Katalyst Healthcares and Lifesciences

Remote or New York, USA

Full-time

Responsibilities: Senior Process Engineer responsible for tech transfers within the manufacturing team. Support GMP-related activities. Experience in tech transfer and project management. Strong technical skills, including report writing and problem-solving. Excellent communication skills, with the ability to clearly relay technical information. Cell Therapy (CAR-T) experience (preferred). Willingness to travel (approximately 25%). t least 5 years of relevant experience.

Specialist, Engineering

Merck & Company Inc

Durham, North Carolina, USA

Full-time

Job Description The Maurice R. Hilleman Center for Vaccine Manufacturing is located in Durham, NC. This state-of-the-art facility established in 2004, manufactures our Company lifesaving vaccines in bulk and finished forms. Due to the importance of this facility in our Company Vaccine Manufacturing network, the facility has seen rapid growth in production volumes and new employees over the last several years; currently Durham employs 1,000+ people. Durham's Technology Transfer Specialist will

Engineer II, Validation

Thermo Fisher Scientific

Remote or St. Louis, Missouri, USA

Full-time

Work Schedule Standard (Mon-Fri) Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc allowed, Cold Room/Freezers -22degreesF/-6degrees C, Laboratory Setting, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.) Job Description As part of the Thermo Fisher Scientific team, you

Senior Specialist, Purification Technical Engineering HPV (DS4)

Merck & Company Inc

Durham, North Carolina, USA

Full-time

Job Description The Maurice R. Hilleman Center for Vaccine Manufacturing is located in Durham, NC. This state-of-the-art facility established in 2004, manufactures our lifesaving vaccines in bulk and finished forms. Due to the importance of this facility in our Vaccine Manufacturing network, the facility has seen rapid growth in production volumes and new employees over the last several years; currently Durham employs 1,000+ people. Durham's Technology Transfer Senior Specialist will be an ener

Field Service Engineer I (lab equipment)

Thermo Fisher Scientific

Colorado, USA

Full-time

Work Schedule Other Environmental Conditions Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cold Room/Freezers -22degreesF/-6degrees C, Fluctuating Temps hot/cold, Laboratory Setting, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.) Job Description Field Service Engineer (lab equipment) When you join us at Thermo Fisher Scientific, you'll be part of an inquis

Sr Technical Operations Training & Support Specialist

Thermo Fisher Scientific

Remote or Greenville, North Carolina, USA

Full-time

Work Schedule Flex Shifts 40 hrs/wk Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Loud Noises (Equipment/Machinery), Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.) Job Description Position Summary: Join Thermo Fisher Scientific Inc. as a Sr Technical training and support engineer and have the unique opportunity to build, grow, and share your expertise in the manuf

Technical Operations Training & Support Specialist

Thermo Fisher Scientific

Remote or Greenville, North Carolina, USA

Full-time

Work Schedule Flex Shifts 40 hrs/wk Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc allowed, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.) Job Description Position Summary: Join Thermo Fisher Scientific Inc. as a Technical training and support engineer and have th

Senior Commissioning, Qualification & Validation (CQV) Engineer

Johnson & Johnson

Remote or Athens, Georgia, USA

Full-time

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn m

Supplier Management Engineer (REMOTE)

Thermo Fisher Scientific

North Carolina, USA

Full-time

Work Schedule Standard (Mon-Fri) Environmental Conditions Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Loud Noises (Equipment/Machinery), Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Warehouse 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

Associate Director, Engineering - Medical Device Combination Products (MDCP) Technical Lead

Merck & Company Inc

Remote or Wilson, North Carolina, USA

Full-time

Job Description We are seeking a highly motivated individual for the role of Associate Director Engineering - MDCP Technical Lead, supporting the Wilson Packaging Technical Operations Team. This role will serve as the primary medical device and combination product (MDCP) point of contact for the site Packaging Technical Operations team. The MDCP Technical Lead will have responsibilities for supporting the design/tech transfer and sustainment activities of MDCPs at the Wilson site and ownership

Mechanical Engineer II

Fresenius Medical Care

Remote or Lawrence, Massachusetts, USA

Full-time

PURPOSE AND SCOPE: The Mechanical Engineer II will play a key role in improving our Home HD products and our patients' lives. This individual will apply sound engineering principles in the support of our current product portfolio and will be involved in different parts of a product's life, including but not limited to the feasibility evaluation for new features and products to improve the quality, performance, and cost of dialysis therapy. You will be part of a team with responsibility for suppo