21 CFR Part 11 Jobs in Chicago, IL

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Sr Manager, Data Sciences

Thermo Fisher Scientific

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Remote or Chicago, Illinois, USA

Full-time

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description At Thermo Fisher Scientific, 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, making sure our food is safe and delivering COVID-19 solutions. As the world leader in serving science, with the largest inve
Posted 60+ days ago | Updated 1 hour ago

Veeva Presales

InfoTech Spectrum Inc

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Remote

Contract

Title: Veeva Presales Location: Remote Job Description: Lead discovery sessions to gather functional and technical requirements relevant to Veeva Vault solutions (e.g., Veeva CRM, Vault Quality Docs, RIM, eTMF, PromoMats, etc.). Articulate the value proposition of Veeva products and services in the context of customer-specific use cases. Content Creation & RFP Management Develop tailored responses to RFPs, RFIs, and capability assessments with detailed solution write-ups, compliance language, a
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Posted 1 day ago

MES Support Lead

Cognizant

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Chicago, Illinois, USA

Full-time

Job Summary Application skill Business Analysis / Requirements gathering for MES Electronic Batch record implementation for a pharma client. Experience on Werum PAS-X System Administration, GMBRs, PVL, PMBR?s, Equipment Management, Material Flow, Weigh & Dispense, EBR, MBR & Master Data Designing and developing State Diagrams in MES Determining updates for Master Data, State Diagrams, Experience on SAP-MES interface, L2 integrations, report development Hands on Experience in Werum PAS-X Specif
Posted 22 days ago | Updated 1 hour ago

Veeva Presales Consultant

NexInfo Solutions, Inc.

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Remote

Contract

Title: Veeva Presales ConsultantLocation: Remote Client Engagement & SolutioningEngage with potential clients to understand their business challenges, current system landscape, and digital transformation needs.Lead discovery sessions to gather functional and technical requirements relevant to Veeva Vault solutions (e.g., Veeva CRM, Vault Quality Docs, RIM, eTMF, PromoMats, etc.).Articulate the value proposition of Veeva products and services in the context of customer-specific use cases.Content
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Posted 1 day ago | Updated 7 hours ago

Lead Engineer - MES Opcenter

Katalyst Healthcares and Lifesciences

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Remote or New York, USA

Full-time

Job Description: The Lead Engineer will lead a team of technical resources to design, develop, configure, and test MES (Manufacturing Execution Systems) solutions. They will be directly responsible for leading resources contracted vi third-party and through other Pharmaceutical organizations to develop & deploy MES application software to Medical Device manufacturing sites globally. Responsibilities: Act as subject matter expert on system design and architecture. Solutioning and designing new
Posted 1 day ago | Updated 1 hour ago

Computer System Validation Analyst - R Studio & Clinical Systems

Katalyst Healthcares and Lifesciences

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Remote or New Jersey, USA

Full-time

Responsibilities: Lead validation planning, risk assessment, and execution for R Studio, GitLab, and Medidata Rave EDC. Develop and execute validation documentation including: Validation Plans (VP.). User Requirements Specifications (URS.). Risk Assessments (RA.). Functional and Design Specifications. Traceability Matrix (RTM.). Test Protocols (IQ/OQ/PQ or CSA-based scripts.). Validation Summary Reports (VSR.). Collaborate with cross-functional stakeholders including Clinical Data Mana
Posted 49 days ago | Updated 1 hour ago

Lead Engineer MES Opcenter

Zettalogix INC

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Remote

Third Party, Contract

Position: Lead Engineer MES Opcenter RemoteDuration: 6 months with opportunity for extension or conversion Job Description:Lead Engineer MES OpCenter The Lead Engineer will lead a team of technical resources to design, develop, configure, and test MES (Manufacturing Execution Systems) solutions. They will be directly responsible for leading resources contracted via a third-party and through other client organizations to develop & deploy MES application software to Medical Device manufacturing s
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Posted 6 days ago | Updated 1 day ago

Veeva Promomats Technical Lead - 100% remote

MSquare Systems Inc.

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Remote

Contract, Third Party

We are seeking a seasoned Veeva PromoMats Technical Lead to oversee a high-impact migration project within the life sciences domain, transitioning digital content, metadata, and workflows from legacy systems or DAM platforms into Veeva Vault PromoMats. This role is responsible for leading the technical design, validation, and execution of the migration while ensuring regulatory compliance, content integrity, and operational continuity for commercial and medical review teams. Key Responsibilities
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Posted 29 days ago | Updated 14 days ago

MES Consultant

BOTG LLC

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Remote

Full-time

Location: Remote Job Type: Full-Time / Contract Industry: Life Sciences / Pharmaceuticals / Manufacturing About the Role: We are seeking experienced MES (Manufacturing Execution System) Consultants with strong backgrounds in Electronic Batch Records (EBR) and Master Batch Record (MBR) design, along with hands-on recipe authoring experience. This is a remote position, ideal for professionals with a solid understanding of GMP-regulated environments, especially in pharmaceutical or biotech manufact
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Posted 58 days ago | Updated 21 days ago

LIMS and QC Applications Consultant

Expedite Technology Solutions

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Remote or Bridgewater, New Jersey, USA

Full-time, Contract

Solution Architecture and Design: Lead the design and development of LabVantage LIMS solutions tailored to business and laboratory needs. Develop system workflows, configurations, and integrations with other enterprise systems (e.g., S4 Hana ERP, MES, ELN, SDMS). Define data models, interface designs, and system configurations. Implementation and Deployment: Oversee installation, configuration, and validation of LabVantage LIMS applications. Develop and execute project plans, ensuring timely an
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Posted 60+ days ago | Updated moments ago

Sr. Manager, SAP CGTO Solutions Architect

Gilead Sciences, Inc.

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Remote or Santa Monica, California, USA

Full-time

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
Posted 26 days ago | Updated 1 hour ago

IBM Maximo EAM Specialist

NTT DATA Americas, Inc

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Remote or Greenville, North Carolina, USA

Contract

IBM Maximo EAM Specialist - 25-05059 100% Remote 6+ Mths Duration W2 or C2C NTT DATA's Client is seeking an IBM Maximo EAM Specialist with15 years of experience validating Maximo systems under 21 CFR part 11 compliance under GMP practices and 2 years successful deployment of MAS 8.X and 9.X in validated Life Science Industry 15 years of experience in EAM including implementation, system installation, customization, configuration, upgrades, patch management, integration and data migration Experi
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Posted 30 days ago | Updated moments ago

Senior CQV Engineer

Johnson & Johnson

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Remote or Athens, Georgia, USA

Full-time

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn m
Posted 51 days ago | Updated 1 hour ago

Manager, Software Development

Fresenius Medical Care

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Remote or Concord, California, USA

Full-time

Manager, Software Development, Fresenius USA, Inc., a Fresenius Medical Care N.A. company, Martinez, California (Hybrid) Responsible for directing software systems development, software application development, and software quality assurance for software enhancements and new products including cloud-based and/or internet-related tools. Will manage a team of software developers to design, code, test, and implement high quality software for dialysis and related products. Will also be responsible
Posted 10 days ago | Updated 1 hour ago

Trackwise Digital Architect

VeridianTech

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Texas, USA

Full-time

Trackwise Digital Architect Remote Requirement Experience with designing and implementing IT systems. Experience with understanding specifications, evaluate current application, gather requirements, and work closely with stakeholders to deliver the right solution Experience working and implementing systems using TrackWise Digital platform. Hands on experience in TrackWise Digital Application setup: Permission Sets, Configuring Platform Custom Settings, Configuring Remote Site Settings, E-s
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Posted 60+ days ago | Updated 2 hours ago

Maximo Admin

Next Level Business Services, Inc.

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Remote

Contract, Third Party

Project Overview: IT OneMaximo Staff Aug as Global System Admin requires in-depth understanding of the OneMaximo system and configurations, including proprietary tools from ABS Consulting. This position supports the system infrastructure (for 5 environments) 11 global sites, performance monitoring, with understanding of OMX policies and procedures to support potential Global TrackWise Deviations, CIS policies and procedures, new user requirements, updates Global configurations and security Matri
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Posted 8 days ago

Staff Engineer Distribution Quality (Hybrid)

Becton Dickinson & Company

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Remote or Covington, Georgia, USA

Full-time

Job Description Summary As a Quality Engineer at our Distribution Center, you will be instrumental in upholding the highest standards of regulatory compliance and product quality. Your role is critical in maintaining operational excellence, with a strong focus on the quality engineering processes specific to the distribution of medical devices and pharmaceuticals. Job Description We are the makers of possible BD is one of the largest global medical technology companies in the world. Advancing
Posted 38 days ago | Updated 1 hour ago

Senior Software Quality Engineer

Johnson & Johnson

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Remote or Santa Clara, California, USA

Full-time

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn m