21 CFR Part 11 jobs in Chicago, IL

Remote

•

3d ago

We have a below position for Veeva Migration expert for remote work, please find the JD below and let me know your interest. Title: Veeva Migration Consultant Exp: 7+ to 10 years of experience in Veeva migration and implementation activities Duration: 6-12 Months Responsibilities: Migration Work stream Lead-Veeva RIMS Implementation Key Responsibilities Migration Strategy & PlanningDefine migration scope, timelines, resources, and success metrics.Develop detailed migration plans and risk mitiga

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Contract, Third Party

Depends on Experience

Clinical eTMF Consultant

Remote or Massachusetts

•

Today

Job Title: Clinical eTMF Consultant Department: Clinical Operations Position Summary: The Clinical eTMF Specialist is responsible for managing and maintaining the Electronic Trial Master File (eTMF) system to ensure compliance with regulatory requirements, internal quality standards, and study timelines. This role ensures that all clinical trial documentation is complete, accurate, and inspection-ready at all times. The eTMF Specialist serves as a key liaison between Clinical Operations, Qual

Third Party, Contract

CSA Auditor, TraceLink

Remote

•

13d ago

We are seeking a Computerized System Assurance (CSA) Auditor with deep experience in TraceLink and GxP-regulated environments to ensure the compliance, validation, and lifecycle integrity of computerized systems supporting serialization, traceability, and supply chain management. This role is critical in evaluating vendors, systems, and processes to meet FDA, EMA, and global regulatory expectations for data integrity and system validation. Key Responsibilities: Plan, conduct, and report CSA aud

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Contract

85 - 90

GxP Lab Computing Engineer

Chicago, Illinois

•

Today

Required Skills: Excellent customer service skills complemented by an ability to listen to and interpret client requests Ability to troubleshoot complex instrument and technology issues Strong oral and written communication skills Ability to identify, track and complete tasks for multiple projects Knowledge of laboratory safety practices as defined by the company and/or customer's site safety code Responsibilities: As a Lab Computing Analyst, beneficiary would perform following key responsib

Full-time

Senior CSV Engineer

Remote or Massachusetts

•

Today

Job Description: We are looking for a Senior Computer System Validation (CSV) Engineer to perform validation of computerized systems associated with Client's facilities, utilities, and equipment for the qc lab validation project. This role will focus on EMS, Client, and laboratory informatics/software platforms (e.g., HPLC/qPCR control software, Sicknotes, Blue Mountain), ensuring compliance with 21 CFR Part 11, Annex 11, and data integrity requirements. The CSV Engineer will obtain documentatio

Full-time

Statistical Software Configuration Specialist (Statistica TIBCO)

Remote or Hybrid in Vacaville, California

•

Today

Statistical Software Configuration Specialist (Statistica TIBCO) Vacaville, CA / A hybrid model (once or twice in the office) / Remote Duration: - 6-12 Months+ For a "Statistica Software configuration specialist" role, which likely involves both data analytics and potentially on-site manufacturing support or collaboration, a hybrid model (once or twice in the office) is a probable arrangement. Statistical Software Configuration Specialist (Statistica TIBCO) Position Overview The Statistical Soft

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Contract, Third Party

Depends on Experience

Senior Staff Software Advance Quality Engineer (REMOTE)

Remote or Portage, Michigan

•

Today

Work Flexibility: Remote or Hybrid or Onsite Senior Staff, Software Quality Assurance Engineer - Remote Stryker is seeking a Senior Staff Software Quality Assurance Engineer to support our Digital Robotics and Enabling Technologies business by driving quality processes. In this role, you will partner with R&D software development teams to guide them through internal quality system processes and ensure compliance with internal procedures and regulatory standards (e.g SOC 2, ISO, FDA and HIPAA)

Full-time

USD 115,600.00 - 245,800.00 per year

CSV and Validation Engineer

Remote or New Jersey

•

Today

Job Description: We are seeking a hands-on CSV and Validation Engineer to validate software used with laboratory instruments and lab informatics platforms. The role owns risk-based validation planning and execution aligned to EMA Annex 11 and 21 CFR Part 11, authors audit-ready documentation, and partners with QA/IT/Lab to transition systems to standardized SOPs. Responsibilities: Plan and execute computer system validation using a risk-based CSA approach aligned to GAMP 5. Validate instrument

Full-time

Director - Lab Informatics

Remote

•

Today

Position Summary: The Director of Lab Informatics is responsible for developing and executing a comprehensive informatics strategy to support laboratory operations across multiple functional areas including analytical development, quality control (QC), and manufacturing science and technology (MSAT). The role will drive innovation and digital transformation by integrating advanced informatics platforms that enhance data integrity, increase operational efficiency, and ensure regulatory complianc

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Contract, Third Party

Director, Lab Informatics

Remote

•

Today

Director, Lab Informatics Job Location- Remote Long Term Position Summary: The Director of Lab Informatics is responsible for developing and executing a comprehensive informatics strategy to support laboratory operations across multiple functional areas including analytical development, quality control (QC), and manufacturing science and technology (MSAT). The role will drive innovation and digital transformation by integrating advanced informatics platforms that enhance data integrity, incre

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Full-time, Part-time, Third Party, Contract

Senior Validation Engineer / Lead

Remote or Durham, North Carolina

•

Today

Job Description Summary The Senior Validation Engineer is a subject matter expert in the Commissioning and Qualification program and provides leadership and mentorship in the qualification of equipment, utilities, and processes. Job Description Location: Durham, NC Please note this role is on-site 5 days a week and does not have the ability to work remotely. This role is based in Durham, NC. Novartis is unable to offer relocation support for this role: please only apply if this location is a

Full-time

USD 103,600.00 - 192,400.00 per year

Sr. IT Program Manager

Remote or Massachusetts

•

Today

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Uncover a remarkable opportunity at Thermo Fisher Scientific Inc. to push global advancements in health, cleanliness, and safety as a Sr. IT Program Manager in Waltham. Become a part of our elite team, guiding ambitious IT projects that enhance quality, compliance, and supply chain operations within our Contract Development and Manufacturing Organization (CDMO). Argument Development & Case Creation Collaborate

Full-time

Sr IT Business Analysis Specialist (Tech Dev Biologics Clinical Manufacturing)

Remote or Foster City, California

•

Today

At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead's team plays a critical ro

Full-time

USD 126,820.00 - 164,120.00 per year

Cyber Security Engineer

Remote

•

Today

Job Description Summary The Caption Health SBU focuses on clinical applications that aid in early disease detection, using AI to assist in conducting ultrasound scans. The Product Security Leader PSR is part of our security team and helps safeguard the integrity, confidentiality, and availability of our healthcare technology products. This role is ideal for an experienced product security analyst who is passionate about building secure, compliant, and resilient systems in a regulated environment

Full-time

Director, Technology - Global Regulatory Operations (GRAAS)

Remote

•

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 pat

Full-time

USD 206,678.00 per year

Manager, IT Business Analysis

Remote or Foster City, California

•

Today

Full-time

USD 146,540.00 - 189,640.00 per year

Associate IT Project Manager-- fully remote

Remote or North Carolina

•

Today

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description At Thermo Fisher Scientific team, you'll discover impactful work, innovative thinking and a culture dedicated to working the right way, for the right reasons - with the customer always top of mind. The work we do matters, like helping customers find cures for cancer, protecting the environment, and supporting our customers' medical related inquiries. As the world leader in serving science, with the largest invest

Full-time

Staff Software Engineer - Hardware Integration

Remote or San Diego, California

•

Today

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 hu

Full-time

USD 124,700.00 - 205,800.00 per year

Principal Agentic AI Chatbot Engineer

Remote or Thousand Oaks, California

•

Today

Full-time

USD 189,750.00 per year

Principal SAP Architect, Enterprise Asset Management (EAM)

Remote

•

Today

Full-time

USD 154,142.00 per year

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21 CFR Part 11 jobs in Chicago, IL, USA