21 cfr jobs in illinois

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

CMO Digital Liaison & Data Steward

Remote

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Today

Business Analyst / Digital Steward CMO Connections Role Overview We are seeking a technically grounded Business Analyst / Digital Steward to support digital connections with external Contract Manufacturing Organizations (CMOs). This person will help own the digital engagement with external manufacturing partners end to end from partner onboarding and tech transfer through commercialization and long-term sustainment of inline products. The role operates across a matrixed portfolio of strategic CM

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Contract

Depends on Experience

QUALITY ENGINEER

Hybrid in Chicago, Illinois

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3d ago

MAJOR RESPONSIBILITIES: Provide Quality expertise in Product Development, QMS, Design Control activities, Design History Files, CAPA, Risk Management, and CE Technical Files. Direct and collaborate with supplier representatives on quality problems, ensure corrective action implementation (CAPA, SCAR), and contribute to supplier quality improvement programs. Lead supplier qualifications. Lead investigations of product and process non-conformances and out-of-specification results and develop ef

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Contract

Depends on Experience

Clinical Project Manager with RBQM, Veeva, CTMS, eTMF, EDC

Remote

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12d ago

Title: Clinical Project Manager with RBQM & Veeva Foster City, CA or Remote for people who can travel for meetings Experience Range: 10- max 22 years Writeup Skills PM with BA background and experience 6+ years of proven expertise in theclinical domain and operations, including hands-on experience with systems likeCTMS, eTMF, RBQM, and EDC. 8+ years of experience analyzing requirements, documenting findings, and ensuring effective communication and clarification with stakeholders. 6+ years of

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Full-time

Depends on Experience

SAP BRH Functional / Support Lead

Remote

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Today

Job Summary: Seeking a Senior SAP Batch Release Hub (BRH) Functional/Support Lead with strong SAP BRH and S/4HANA QM expertise to support implementation, production sustainment, hyper care, and go-live activities in a regulated Life Sciences environment. Key Responsibilities Lead SAP BRH implementation, design, and production support. Handle P1/P2 incidents, RCA, defect resolution, integration troubleshooting, and hypercare. Support S/4HANA QM, including batch management, inspection lots, usage

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Contract

Depends on Experience

Mendix Platform Architect

Remote

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3d ago

Mendix Platform Developer/Architect|| Location Jacksonville, FL Remote || Employment type - contract Job Description: 10 years of software development experience. 5 years of Mendix development experience Experience serving as a solution architect or technical lead. Experience delivering enterprise-scale applications. Technical Skills Mendix Platform Architecture Mendix Studio Pro Microflows and Nanoflows Domain Modeling XPath and OQL Java Actions REST and SOAP APIS SQL Databases Azure

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Third Party, Contract

$65 - $70

Senior CSV Engineer

Chicago, Illinois

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Today

Job Description: The Senior Computer System Validation (CSV) Engineer is responsible for leading validation activities for computerized systems used in regulated environments such as pharmaceutical, biotechnology, or medical device manufacturing. This role ensures that systems including LIMS, ERP, MES, and laboratory applications are validated in compliance with FDA, EU, and global regulatory requirements. The Senior CSV Engineer will act as a subject matter expert (SME), providing guidance on v

Full-time

Validation Engineer

Round Lake, Illinois

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Today

Job Summary: We are seeking an experienced Validation Engineer to support system-level Verification & Validation (V&V) activities for medical device products. The role involves planning and executing V&V activities, developing and executing validation protocols, supporting design verification, and ensuring compliance with FDA, ISO 13485, and internal quality system requirements. Experience with infusion pump systems or similar electromechanical medical devices is preferred. Roles & Responsibilit

Full-time

Senior Engineering/ IT Program Manager

Remote or Ponce, Ponce

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Today

Job Title: Senior Engineering/ IT Program Manager Client: Medical Device Manufacturing Company Duration: 12 Months Location: 100% Remote (Travel to Ponce, Puerto Rico as needed) Role Overview Lead large cross-functional engineering programs Support manufacturing, digital transformation, and regulated systems Work across Engineering, Manufacturing, Quality, Regulatory, and IT Program Leadership Manage enterprise engineering programs Build roadmaps, milestones, and resource plans Deliver withi

Full-time

Business Application & Systems Administrator

Remote or Boston, Massachusetts

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Today

Job Description The Business Applications & Systems Administrator is responsible for managing, implementing, and optimizing business applications. The role will develop & coordinate testing with impacted departments, including specifically coordinating with IT and Quality for validation & compliance. Manages business application projects, ensuring effective communication across teams/functions as well as informing management of progress and key issues. Key Responsibilities Application Managem

Full-time

USD 116,800.00 - 219,000.00 per year

Senior PLM Windchill Solution Architect

Remote

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4d ago

Position OverviewWe are looking for aSenior PLM Windchill Solution Architectto lead a strategic, customer-facing PLM engagement for a leadingMedical Device / Life Sciences organization.The ideal candidate will be a senior techno-functional architect with strongPTC Windchill PLMexpertise and experience owning end-to-end architecture, technical governance, integrations, migration, validation, AMS, and customer stakeholder management.Key ResponsibilitiesLead end-to-endPTC Windchill PLM solution arc

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Contract

80 - 90

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

SME - Reviewer Scientist

Remote

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6d ago

Subject Matter Expert - Reviewer ScientistThe SME - Reviewer Scientist will provide scientific and regulatory expertise in reviewing clinical and nonclinical data submitted in support of drug applications. This position will support projects within the FDA Center for Drug Evaluation and Research (CDER), Office of Computational Science, under the direction of the COR. Responsibilities: Review clinical safety and efficacy studies submitted in support of drug applications. Evaluate clinical and non

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Full-time

Depends on Experience

Validation Engineer

Hybrid in Chicago, Illinois

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4d ago

QUALITY ENGINEER / QUALITY COMPLIANCE ENGINEER our client is looking to hire 15-20 people Will provide cross-divisional support for remediation efforts. Under broad supervision, responsible for independently setting and upholding quality standards for portfolio of medical device, commodity, OTC drug, and/or cosmetic products. Evaluate production process, recommend improvements, qualify and conduct vendor management, generate and maintain DMRs, product specifications, design control files, and CE

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Contract

Depends on Experience

Senior Technical Business Analyst

Remote

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6d ago

DescriptionJob Title: Senior Healthcare Business Analyst Type: Part Time Experience Level: Senior Seeking a highly skilled and experienced Senior Business Analyst responsible for bridging the gap between business objectives and technology solutions, ensuring that our projects align with organizational goals and deliver maximum value. You will utilize your expertise in business analysis and data-driven decision-making to identify opportunities for improvement and drive successful project outcomes

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Part-time

Depends on Experience

Sr SampleManager Implementation Engineer

Remote or Indiana

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Today

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Senior SampleManager LIMS Implementation Engineer How will you make an impact? As a Senior SampleManager LIMS Implementation Engineer, you will be a technical expert responsible for the configuration, implementation, integration, and deployment of Thermo Scientific SampleManager LIMS solutions. This role is highly hands-on and focused on translating defined laboratory processes and solution designs into robus

Full-time

USD 93,800.00 - 140,675.00 per year

Project Manager- Life science industry

Remote

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14d ago

Job Title: Project ManagerLife science industryLocation: Foster City, CA (Fully remote)Duration: FTEEducational Qualification*Any Bachelor''s DegreeExperience Range10 YearsTagline/Tech Stack Snapshot -PM with BA background and experienceRole Summary - (To be filled by Practice /DO)We are seeking a PM and Business Analyst with requirements gathering, documentation, and stakeholder engagement within the clinical domain. The ideal candidate will have strong expertise in analyzing and translating bu

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Full-time, Third Party

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SAP Delivery Manager (ERP) Life Sciences

Remote

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28d ago

SAP Delivery Manager (ERP) Life Sciences Devfi, Inc. 100% remote Salary: DOE About Devfi Devfi, Inc is an SAP services partner to life sciences and pharmaceutical companies. We deliver S/4HANA implementations for global pharma manufacturers, CDMOs, biotech and medical device clients across the Globe. Our clients operate under FDA, EMA and MHRA,GxP oversight. Every system we touch is validated and every change is auditable that standard is why they choose a specialist partner over a generalist.

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Contract

Depends on Experience

Senior Human Factors Engineer

Hybrid in Northfield, Illinois

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Today

Job Summary This position is responsible for leading Human Factors and Usability Engineering activities across the product lifecycle to ensure medical devices (Class I and II) are safe and effective for use. This engineer will collaborate with cross-functional project teams to improve product designs (new and existing), specifically the device user interfaces, including the device, packaging, labeling, and instructions for use, while minimizing the potential for use errors. This position will a

Full-time

USD 101,000.00 - 152,000.00 per year

Principal System Engineer

Lincolnshire, Illinois

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Today

Full Spectrum partners with leading companies in MedTech to develop cutting-edge software for medical devices. With projects focused on embedded systems, mobile apps, robotics, engineers at Full Spectrum love the challenge of working with clients on products that have a meaningful impact. Working across different client projects with a wide range of technologies, a career at Full Spectrum offers both technical and professional growth opportunities. Principal System Engineer: At Full Spectrum,

Full-time

USD 150,000.00 - 205,000.00 per year

21 cfr jobs in Illinois, USA