21 cfr 210 jobs in remote

Billerica, Massachusetts

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9d ago

Process Engineer IIWe are seeking an experienced Process Engineer II to support radiopharmaceutical manufacturing operations. In this role, you will provide technical support to automated manufacturing lines, troubleshoot process and equipment issues, lead deviation investigations and CAPAs, and support process validation, equipment qualification, and continuous improvement initiatives. You will work closely with Manufacturing, Quality, Engineering, and Supply Chain teams to ensure safe, complia

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Contract

Depends on Experience

Auditor

Remote or Chicago, Illinois

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Today

Job Title: Quality Auditor Locations: Remote (50 - 60% Travel is expected anywhere in US but that will be sponsored) Duration: 6 months Contract Pay Range: $40 - $43/hr. Must Have's 8+ years of Quality Assurance and Quality Auditing experience within the medical device or pharmaceutical industry Extensive experience leading supplier/vendor audits from planning through final reporting Expert knowledge of FDA regulations (21 CFR Parts 210, 211, and 803), ISO 13485, and Quality Management Systems

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Full-time

$40.0000 - $43.0000

Validation Engineer

Houston, Texas

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Today

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

Engineer 2, Sterilization

Ellettsville, Indiana

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Today

Overview The Engineer 2, Sterilization works cross-functionally to support daily sterilization operations, as well as local and global process and equipment improvement projects, to meet the needs of the local entity and global organization. The position will utilize multiple engineering and scientific disciplines to support complete life-cycle of projects, equipment, and systems. Responsibilities - Support in project planning, documentation, design, construction, start-up, commissioning, and

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

LSA QA Sr. Compliance Specialist

Portsmouth, New Hampshire

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Today

LSA QA Sr. Compliance Specialist Location: This position is based in our Portsmouth, NH office. The typical work schedule is Monday through Friday, 7:00 AM?4:00 PM EST. What you will get: Below you will find a comprehensive summary of the benefits package we offer: Performance-related bonus. Medical, dental and vision insurance. 401(k) matching plan. Life insurance, as well as short-term and long-term disability insurance. Employee assistance programs. Paid time off (PTO). Compensation

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

Validation Engineer 2

Bend, Oregon

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Today

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

Process Engineer MS&T

Princeton, New Jersey

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Today

Process Engineer MS&T About Site Catalent's Princeton, New Jersey site is a key part of the company's cell therapy network and serves as a U.S. commercial manufacturing facility for autologous and allogeneic cell therapies. The site is equipped to support the full product lifecycle, including late-stage clinical development, process characterization, and commercial-scale CGMP manufacturing across a wide range of cell types. With flexible cleanroom suites, quality control laboratories, and an e

Full-time

USD 105,000.00 - 125,000.00 per year

Process Engineer - Sterile Compounding- Mesa,AZ

Mesa, Arizona

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Today

Hims & Hers is the leading health and wellness platform, on a mission to help the world feel great through the power of better health. We are redefining healthcare by putting the customer first and delivering access to care that is affordable, accessible, and personal, from diagnosis to treatment to delivery. No two people are the same, so we provide access to personalized care designed for results. By normalizing health & wellness challenges and innovating on their solutions, we're making bette

Full-time

Manager - Validation Lead - Technical Support & Operations - Global Services

Indianapolis, Indiana

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Today

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work-but i

Full-time

USD 64,500.00 - 151,800.00 per year

Validation Engineer

Hartland, Wisconsin

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Today

Job Summary Responsible for the validation of facility utilities, and equipment processes 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 processes are executed with consistent quality and results within a controlled environment. Responsible for managing and or performing revalidation, engineering s

Full-time

USD 73,000.00 - 110,000.00 per year

Regulatory Affairs Specialist

New Jersey

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4d 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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Third Party, Contract