21 CFR 210/211 jobs

Lexington, Massachusetts

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Today

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description Pursuant to Section 20 C.F.R. 656.10, you are hereby notified that an application for Alien Employment Certification will be filed by

Full-time

USD 104,541.00 - 141,240.00 per year

Validation Engineer II

Houston, Texas

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13d ago

Summary : We are seeking a Validation Engineer II to support critical validation activities within a pharmaceutical / biopharmaceutical manufacturing environment. The ideal candidate will have hands-on experience in Commissioning, Qualification, and Validation (CQV), including the development and execution of Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for equipment, utilities, facilities, and Controlled Temperature Units. Roles and Respon

Full-time

Quality Engineer

Hybrid in Phoenix, Arizona

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21d ago

Quality Engineer Phoenix, AZ We are seeking a Quality Engineer to support quality and compliance activities within pharmaceutical, biotechnology, and medical device manufacturing environments. The Quality Engineer will work with cross-functional teams to identify quality issues, investigate root causes, implement corrective actions, and support continuous improvement initiatives. Key Responsibilities Support quality assurance and quality control activities in manufacturing environments.Investiga

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Contract

Depends on Experience

Computer Systems Validation Engineer

Boston, Massachusetts

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Today

Are You Ready? CAI is a professional services company established in 1996 that has grown to more than 700 people worldwide. We provide commissioning, qualification, validation, startup, project management, and other consulting services associated with operational readiness to FDA-regulated and other mission-critical industries. Our approach is simple-we put the client's interests first, we don't stop until it's right, and we do whatever it takes to get there. Our Foundational Principles: - W

Full-time

USD 75,000.00 - 106,000.00 per year

Principal Validation Engineer

Indianapolis, Indiana

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Today

What Manufacturing Engineering contributes to Cardinal Health Engineering is responsible for performing research and analyses to develop design options for components, products, systems and processes. Manufacturing Engineering is responsible for developing manufacturing processes, production floor layouts and associated tools. Reviews new designs for manufacturability. Designs process improvements to reduce product cost, process cycle time and improved product quality. Job Summary The Princi

Full-time

USD 82,100.00 - 128,920.00 per year

Equipment Validation Engineer 2

Durham, North Carolina

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Today

Position Overview We are seeking an Equipment Validation Engineer II to support the qualification of manufacturing equipment and utilities in our GMP facility. You will develop and execute risk-based validation strategies, author and run IQ/OQ/PQ protocols, and partner with cross-functional teams to ensure compliant, reliable operations. 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

Full-time

Validation Engineer (Onsite - Columbia, MO)

Columbia, Missouri

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Today

Thank you for your interest in joining Solventum. Solventum is a new healthcare company with a long legacy of solving big challenges that improve lives and help healthcare professionals perform at their best. At Solventum, people are at the heart of every innovation we pursue. Guided by empathy, insight, and clinical intelligence, we collaborate with the best minds in healthcare to address our customers' toughest challenges. While we continue updating the Solventum Careers Page and applicant mat

Full-time

USD 106,000.00 - 145,750.00 per year

Senior Process Development & Technology Engineer (Device Assembly)

Rensselaer, New York

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Today

Build our future together: At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a hands-on Process Characterization and Technology Engineer to develop, characterize, and scale GMP assembly processes for drug-delivery device combination products, as well as for packaging and labeling operations. This person will provide technical support to manufacturing, quality and CMC Regulatory for manufacturing processes from technol

Full-time

USD 67,400.00 - 128,700.00 per year

MES Engineer

Jaffrey, New Hampshire

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Today

Work Your Magic with us! Start your next chapter and join MilliporeSigma. Ready to explore, break barriers, and discover more? We know you've got big plans - so do we! Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious mind

Full-time

USD 87,000.00 - 130,400.00 per year

Commissioning, Qualification, and Validation (CQV) Engineer

Raleigh, North Carolina

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Today

Company Description Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate.

Full-time

Commissioning, Qualification, and Validation (CQV) Engineer

Lancaster, Pennsylvania

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Today

Full-time

Commissioning, Qualification, and Validation (CQV) Engineer

Boston, Massachusetts

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Today

Full-time

Commissioning, Qualification, and Validation (CQV) Engineer

Edison, New Jersey

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Today

Full-time

Validation Engineer 2

Bend, Oregon

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13d ago

Job Description: Client is seeking a contractor-level CSV/CQV Specialist to support a high-priority backlog of qualification and validation activities within the CQV department. This role will provide validation support for analytical laboratory instruments, computerized systems, and GMP equipment while partnering closely with both the Instrumentation and CQV teams. The successful candidate will split time supporting Dawn Bosco's CQV priorities and the Instrumentation team's CSV activities. This

Full-time

Validation Engineer

Houston, Texas

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13d ago

Summary : We are looking for a Validation Engineer II with experience in the pharmaceutical or biopharmaceutical industry to join our growing team. Roles & Responsibilities: Develop and execute IQ, OQ, PQ validation protocols and reports for equipment, utilities, and facilities. Perform CQV activities, including Temperature Mapping for Controlled Temperature Units (CTUs). Collaborate with Manufacturing, QA, Engineering, and R&D teams. nalyze validation data, investigate deviations, and support C

Full-time

Regulatory Affairs Specialist

New Jersey

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8d ago

IKCON TECHNOLOGIES INC delivers exceptional IT services and solutions that provide clients with definite edge over competitors and promoting highest standards of quality. We are currently looking for a Regulatory Affairs Specialist with one of our clients in Remote, Remote. If you are actively looking for opportunities, please send us your updated resume with your contact details. JOB TITLE Regulatory Affairs Specialist/Senior Specialist for Drug-Device Combination Products CITY Remote STATE

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Contract, Third Party