21 CFR Part 11 jobs in Chicago, IL

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

Remote

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24d 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

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

Principal LIMS Developer

Remote

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3d ago

Hi Associate, Greetings for the day, We have a position as a Principal LIMS Developer role for Remote. Please find the job description below for this position. Role: Principal LIMS Developer Location: Remote Duration: 18 Months Overview: Lead the technical direction of a major Laboratory Information Management System (LIMS) modernization initiative focused on designing and delivering a future-state laboratory platform. This role combines architecture, hands-on development, technical leadersh

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Contract

Depends on Experience

Business Analyst with Clinical Trails _12+ Years Experience

Remote

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2d ago

Requirement details: Role: Business Analyst with Clinical Trails Location: Remote Duration: 12+ Months Job Description: 10+ Years of Experience The Business Analyst (BA) will serve as a key liaison between clients, product teams, clinical operations, and technical delivery teams. The BA will gather, analyze, and translate complex clinical trial requirements into functional specifications for eSource, DDC, and eCOA solutions. This role requires strong understanding of clinical trial processes, d

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Contract, Third Party

Depends on Experience

Digital Engineer - POMS MES

Remote

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2d ago

Job Description: Role: Digital Engineer - POMS MES Location: Remote Duration: Long term Job Description Client is seeking an experienced POMS MES Techno-Functional SME with deep expertise in Manufacturing Execution Systems (MES) within a GxP-regulated pharmaceutical manufacturing environment. The ideal candidate will serve as a trusted advisor and bridge between business stakeholders, manufacturing operations, quality organizations, validation teams, and technical delivery teams to support, enha

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Contract, Third Party

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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26d 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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Sr Mngr, Full Stack Clinical Platform Engineer

Remote or Almont, Colorado

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Today

Description: Remote Our client seeks a Full Stack Clinical Platform Engineer to design, implement, and operate production-grade Generative AI and Machine Learning solutions that support Global Development Digital Transformation. The role sits at the intersection of data engineering and applied AI. It partners with Clinical Operations, Data Management, Regulatory, and IT to build and maintain modern data platforms and AI-enabled pipelines that underpin the transformation program. The position r

Contract

Validation Lead-Remote

Remote or Raritan, New Jersey

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Today

Role: Validation Lead Location: Raritan, NJ(Hybrid) Duration: 6+ Months Job Description: Job Details: 5+ years of Computer System Validation (CSV) experience in GxP-regulated environments, with hands-on experience in retro-validation activities and 21 CFR remediation projects with knowledge of CSA, GAMP 5, 21 CFR Part 11, Annex 11, and audit/inspection readiness. Experience in the Pharmaceutical, biotechnology, or medical device industry Experience in FDA and/or Global regulated environment

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Contract

Associate Director, Biostatistics & AI

Remote

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Today

Mavericks Wanted When was the last time you achieved the impossible? If that thought feels overwhelming, you might want to pause here, but if it sparks excitementread on In 2015, we pioneered a "moneyball for biotech" approach, pooling projects and promising early-stage research from academia together under one financial umbrella to reduce risk and unleash innovation. This model allows science and small teams of experts to lead the way. We build bridges to groundbreaking advancements in rare dis

Full-time

USD 173,800.00 - 217,000.00 per year

Associate Director, RBQM Data Enablement and Analytics

Remote or 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 Accountabilities: Configure Centralized Monitoring platform, including DQA, QTLs and KRIs, to identify and manage critical study risk

Full-time

USD 154,400.00 - 242,550.00 per year

Solutions Engineer, Life Sciences

Remote

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Today

Who we are At Domino, we build software that helps the largest, AI-driven organizations build and operate advanced data science and AI solutions at scale. Our platform integrates a streamlined model development environment, MLOps capabilities, and novel features for collaboration, reuse, and reproducibility - all of which make data science teams more productive, reduce time to value, and ensure compliance. Our customers - like Johnson & Johnson, GSK, Bristol Myers, UBS, FINRA and the US Navy -

Full-time

USD 160,000.00 - 230,000.00 per year

MES & Industrial Automation Engineer (Remote - United States)

Remote or Minnesota

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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

Lead Data Manager/SAS programmer (Job 1425)

Remote

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Today

About Us DLH delivers improved health and national security readiness solutions for federal programs through science research and development, systems engineering and integration, and digital transformation. Our experts in public health, performance evaluation, and health operations solve the complex problems faced by civilian and military customers alike by leveraging advanced tools - including digital transformation, artificial intelligence, data analytics, cloud enablement, modeling, and sim

Full-time

USD 130,000.00 - 175,000.00 per year

Manager, IT Assurance and Compliance-Quality Systems

Remote

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Today

Job Description Position Summary The Manager, IT Assurance and Compliance - Quality Systems is responsible for leading and managing the IT Quality Compliance program, ensuring alignment with corporate and site quality and compliance initiatives. This role oversees the establishment, maintenance, and continuous improvement of global IT assurance and compliance processes, including computer software assurance (CSA), software quality management (SQM), and regulatory compliance (GxP, SOX, and other

Full-time

Computer Systems Validation Engineer

Remote

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Today

Location: This position may be performed remotely, but requires the flexibility and willingness to travel as needed. The Opportunity Praxis is hiring a Lead Computer System Validation Engineer to help shape how Computer System Validation is done as we scale. This is a builder role: you'll own validation strategy across our growing GxP technology portfolio, help develop our CSV capabilities and team, and challenge us to continuously improve how we apply modern, pragmatic, risk-based validation.

Full-time

USD 150,000.00 - 178,000.00 per year

Lead Software Platform Engineer, MLOps

Remote

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Today

Who We Are TetraScience is the Scientific Data and AI Cloud company. We are catalyzing the Scientific AI revolution by designing and industrializing AI-native scientific data sets, which we bring to life in a growing suite of next gen lab data management solutions, scientific use cases, and AI-enabled outcomes. TetraScience is the category leader in this vital new market, generating more revenue than all other companies in the aggregate. In the last year alone, the world's dominant players in

Full-time

USD 200,000.00 - 270,000.00 per year

SAP Principal Architect, Transportation Management

Remote

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Today

Career Category Information Systems 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 pati

Full-time

USD 167,720.30 - 226,915.70 per year

Staff Enterprise Applications Developer - IBM Maximo

Remote or San Diego, California

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Today

The Company Dexcom Corporation (NASDAQ DXCM) is a pioneer and global leader in continuous glucose monitoring (CGM). Dexcom began as a small company with a big dream: To forever change how diabetes is managed. To unlock information and insights that drive better health outcomes. Here we are 25 years later, having pioneered an industry. And we're just getting started. We are broadening our vision beyond diabetes to empower people to take control of health. That means personalized, actionable insig

Full-time

USD 116,600.00 - 194,400.00 per year

21 CFR Part 11 jobs in Chicago, IL, USA