21 CFR Part 11 Jobs in Chicago, IL

Refine Results
1 - 20 of 22 Jobs

Sr. Systems Analyst - Remote

VIVA USA INC

•

Remote

Contract

Title: Sr. Systems Analyst - Remote Mandatory skills: DOORS Next Gen, ETM, DNG, Engineering Test Management, DOORS Classic, Admin, Project Management, IBM Rationale SaaS systems, IBM systems, medical device product development, medical devices computer systems validation, 21 CFR Part 11 requirement, application systems requirements, application system specifications, application solutions, maintenance, production support, conceptual system requirements, job flows, program specifications, system
Easy Apply
Posted 28 days ago | Updated 3 days ago

Lead Engineer MES OpCenter

New York Technology Partners

•

Remote

Contract

Job Title: Lead Engineer MES OpCenter Location: 100% Remote Experience: 12+ Years JD: 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 responsibility for leading resources contracted via a third-party and through other J&J organizations to develop & deploy MES application software to Medical Device manufacturing sites globally. The Lead Engineer will b
Easy Apply
Posted 18 days ago

Software Engineering SMTS

Salesforce

•

Remote or San Francisco, California, USA

Full-time

To get the best candidate experience, please consider applying for a maximum of 3 roles within 12 months to ensure you are not duplicating efforts. Job Category Software Engineering Job Details About Salesforce We're Salesforce, the Customer Company, inspiring the future of business with AI+ Data +CRM. Leading with our core values, we help companies across every industry blaze new trails and connect with customers in a whole new way. And, we empower you to be a Trailblazer, too - driving you
Posted 12 hours ago | Updated 1 hour ago

Software Engineering LMTS

Salesforce

•

Remote or San Francisco, California, USA

Full-time

To get the best candidate experience, please consider applying for a maximum of 3 roles within 12 months to ensure you are not duplicating efforts. Job Category Software Engineering Job Details About Salesforce We're Salesforce, the Customer Company, inspiring the future of business with AI+ Data +CRM. Leading with our core values, we help companies across every industry blaze new trails and connect with customers in a whole new way. And, we empower you to be a Trailblazer, too - driving you
Posted 12 hours ago | Updated 1 hour ago

SAP Functional/Technical Consultant with Validation Expertise

iTvorks Inc

•

Chicago, Illinois, USA

Contract

SAP Functional, Technical with Validation Knowledge - Job DescriptionJob Title: SAP Functional/Technical Consultant with Validation Expertise Experience: [X] Years in SAP with Validation KnowledgeEmployment Type: [Full-time/Contract]Job Summary:We are seeking an experienced SAP Functional/Technical Consultant with strong knowledge of SAP validation (GxP, CSV, SOX) to support implementation, customization, and compliance of SAP systems. The ideal candidate will have expertise in SAP modules (MM,
Easy Apply
Posted 3 hours ago

Sr Manager, Data Sciences

Thermo Fisher Scientific

•

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

DOORS Administrator (W2 Only)

Generis TEK Inc.

•

Remote

Contract

We have Contract role DOORS Administrator (W2 Only) for our client at Sylmar CA. Please let me know if you or any of your friends would be interested in this position. Position Details: DOORS Administrator (W2 Only)-REMOTE-Sylmar CA Location : REMOTE Project Duration : 12+ Months Contract with potential to extend Pay Rate : $65/hr. on W2 Job Description: Responsible for configuration of IBM Rationale SaaS systems, specifically DOORS Next Gen (DNG) and Engineering Test Management (ETM). - Must ha
Easy Apply
Posted 4 days ago | Updated 15 hours ago

Manual QA with healthcare experience

Techsunsoft

•

Remote

Contract

Title - Manual QA with healthcare experience Location: Remote Work Type: W2 Contract Start Date: ASAP Job Description:We are looking for a Senior QA Engineer with deep expertise in healthcare processes and AI driven applications. This role is critical in ensuring the safety, accuracy, and compliance of our healthcare-focused AI products. The ideal candidate will have a strong background in QA methodologies (both manual and automated testing, building test cases, writing test plans, etc.), exper
Easy Apply
Posted 1 day ago

Computer System Validation Analyst - R Studio & Clinical Systems

Katalyst Healthcares and Lifesciences

•

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 47 days ago | Updated 1 hour ago

Lead Engineer MES Opcenter

Zettalogix INC

•

Remote

Contract, Third Party

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
Easy Apply
Posted 4 days ago

Veeva Promomats Technical Lead - 100% remote

MSquare Systems Inc.

•

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
Easy Apply
Posted 27 days ago | Updated 12 days ago

MES Consultant

BOTG LLC

•

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
Easy Apply
Posted 56 days ago | Updated 19 days ago

LIMS and QC Applications Consultant

Expedite Technology Solutions

•

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
Easy Apply
Posted 60+ days ago | Updated moments ago

Sr. Manager, SAP CGTO Solutions Architect

Gilead Sciences, Inc.

•

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 24 days ago | Updated 1 hour ago

IBM Maximo EAM Specialist

NTT DATA Americas, Inc

•

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
Easy Apply
Posted 28 days ago | Updated moments ago

Senior CQV Engineer

Johnson & Johnson

•

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 49 days ago | Updated 1 hour ago

Lead Technology Solutions Engineer - PAS-X MES

Johnson & Johnson

•

Remote or Raritan, New Jersey, 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 13 days ago | Updated 1 hour ago

Manager, Software Development

Fresenius Medical Care

•

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 8 days ago | Updated 1 hour ago

Trackwise Digital Architect

VeridianTech

•

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
Easy Apply
Posted 60+ days ago | Updated moments ago

Maximo Admin

Next Level Business Services, Inc.

•

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
Easy Apply
Posted 6 days ago