21 CFR Part 11 jobs in Chicago, IL

Remote

•

2d ago

Qualifications: Bachelor s or Master s degree in Computer Science, Data Engineering, Life Sciences, or a related field.3+ years of experience in data engineering, preferably within clinical research, pharma, or healthcare domains.Strong experience with ETL/ELT tools, data integration, and data ingestion pipelines.Proficient in SQL, Python, and/or Scala for data engineering tasks.Experience with cloud-based platforms such as AWS, Azure, or Google Cloud Platform, and tools like Databricks, Snowfla

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Third Party, Contract

Depends on Experience

Senior Clinical Data Manager

Remote

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17d ago

100% Remote Job Description Senior Clinical Data Manager Role Overview We are seeking an experienced Clinical Data Manager (CDM) to support multiple outsourced clinical studies. The ideal candidate will have strong hands-on expertise in EDC systems, data review activities, vendor data reconciliation, and CRO oversight. Responsibilities Manage 4 concurrent clinical studies outsourced to CROs, ensuring data integrity and compliance. Oversee day-to-day data review activities in the EDC, including

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Contract, Third Party

$50 - $90

Google Cloud Platform Auditor - IT SaaS

Remote

•

17d ago

Education: Bachelor s degree in Life Sciences, Pharmacy, Chemistry, or a related field.Experience: Minimum 10+ years in Healthcare/Pharma QA, including 7+ years in Google Cloud Platform audit (preferably in SaaS platforms).Vendor Audits: Ability to assess third-party SaaS providers for compliance with contractual and regulatory obligations.Regulatory Knowledge: Strong expertise in ICH Google Cloud Platform E6, FDA, EMA, HIPAA, 21 CFR Part 11, and global standards. Experience working with clinica

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Contract

Depends on Experience

R&D Business Systems Lead (BSA/PM) with Life Sciences -GxP Expereince

Remote

•

18d ago

Hi , This is Sagar from KSource Inc. We have an excellent job opportunity for you below is the JD please have a look. Job Title: R&D Business Systems Lead (BSA/PM) Location: Cambridge, MA (Remote) Duration: 12+ months Qualifications & Experience Required: 8+ years of combined experience in Life Sciences IT, including:Minimum 4 years in a GxP-regulated system administrator or support capacity.Minimum 4 years in project management, delivering cross-functional systems in R&D or Clinical domains.Str

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Contract

Depends on Experience

Clinical Data Engineer- "Clinical Research AND Pharma experience is Mandatory"

Remote

•

Today

We are seeking a skilled and motivated Clinical Data Engineer to join our data engineering team supporting clinical research and development initiatives. This role will focus on building and maintaining robust data pipelines to ingest, transform, and manage clinical trial and operational data across various sources and platforms. The ideal candidate has a strong background in data engineering within a life sciences, with experience supporting GxP or regulated data workflows. Qualifications: Bach

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Contract

$52 - $60

W2-Remote :: Senior QA Auditor / Computer System Validation (CSV) in Life Sciences Domain

Remote

•

Today

Senior QA Auditor / Computer System Validation (CSV) in Life Sciences Domain 6-12 Months EST Zone (Remote) Position Overview: An accomplished Senior QA Auditor with a background in life sciences is required for a contract position that could extend from 6 months up to 12 months, with potential for permanent employment. This professional will play a vital role within a dynamic 18-person team, focusing on quality assurance and regulatory compliance across the US&C regions. The role entails perfor

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Full-time

Depends on Experience

Sr. IT Project Manager (Windchill 13 Upgrade)

Remote

•

Today

Sr. IT Project Manager (Windchill 13 Upgrade) 12-month contractRemote Job Summary Sr. IT Project Manager (Windchill 13 Upgrade) Provide leadership and guidance to cross-functional project teams consisting of business, quality, and IT professionals engaged in planning and implementing solutions of varying sizes and complexities. This role is pivotal in ensuring the successful execution of the Windchill+ v13+ upgrade, with a strong emphasis on quality systems compliance, validation, and enterpris

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Contract

Depends on Experience

Controls Engineer (DeltaV)

Remote

•

Today

Title: Controls Engineer (DeltaV) Location : Remote - but must be in the Kalamazoo, MI area Target Start Date : ASAP Type: Direct Hire Salary : $120-160K (DOE) plus uncapped bonus Our client, a Top 5 systems integrator for automation & controls systems with over 40 years of experience, is seeking an experienced Controls Engineer to design, configure, and implement Emerson DeltaV automation solutions, primarily for life sciences and other process manufacturing industries. This role involves deliv

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Full-time

USD 120,000.00 - 160,000.00 per year

IT Project Manager - Windchill

Remote

•

Today

IT Project Manager Windchill 106 Provide leadership and guidance to cross-functional project teams consisting of business, quality, and IT professionals engaged in planning and implementing solutions of varying sizes and complexities. This role is pivotal in ensuring the successful execution of the Windchill+ v13+ upgrade, with a strong emphasis on quality systems compliance, validation, and enterprise alignment. Essential Duties and Responsibilities Project Leadership & Execution Lead the pla

Third Party, Contract

SAP BTP Architect

Remote

•

Today

Role: SAP BTP Architect Location: Onsite preferred but Remote is fine (Memphis, TN) Type of Employment: Contract Certifications: SAP S4HANA Role Description: Lead the design and delivery of enterprise integrations on SAP Business Technology Platform (BTP) with a primary focus on SAP Cloud Platform Integration (CPI/SAP Integration Suite). You will architect, implement, and govern integrations between SAP (S/4HANA/ERP/EWM/IBP/etc.), MOM/Manufacturing systems (e.g., Siemens Opcenter, Rockwell Fac

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Contract, Third Party

SAP ABAP Developer

Remote or Boston, Massachusetts

•

Today

Solution IT Inc. is looking for SAP ABAP Developer for one of its clients in Boston/Remote Job Title: SAP ABAP Developer Summary We are seeking an experienced SAP ABAP Developer to support and enhance SAP systems critical to our global medical device operations. This role will help deliver secure, compliant, and innovative SAP solutions aligned with business needs and SAP best practices, across manufacturing, quality, supply chain, and regulatory functions. The ideal candidate will bring techni

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Full-time, Contract, Third Party

SAP BTP Consultant

Remote

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4d ago

Job Role: SAP BTP Consultant Location: Memphis, TN Duration: 12+ months Role Description: Lead the design and delivery of enterprise integrations on SAP Business Technology Platform (BTP) with a primary focus on SAP Cloud Platform Integration (CPI/SAP Integration Suite).You will architect, implement, and govern integrations between SAP (S/4HANA/ERP/EWM/IBP/etc.), MOM/Manufacturing systems (e.g., Siemens Opcenter, Rockwell FactoryTalk), and ASRS/AGV ensuring secure, compliant, and highly availabl

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Third Party, Contract

Depends on Experience

Senior Commissioning, Qualification & Validation (CQV) Engineer

Remote or Athens, Georgia

•

Today

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

Full-time

IBM Maximo EAM Specialist

Remote

•

Yesterday

Job Title: IBM Maximo EAM Specialist Job Location: RemoteDuration: 6+ months contract About Edify Headquartered in Naperville, IL, we are a dynamic team with over two decades of industry expertise, dedicated to delivering robust business solutions, staff augmentation, and a comprehensive range of application and web services. Recognized as one of Inc. Magazine's Fastest Growing Private Companies, we're committed to empowering businesses with innovative technology solutions. At Edify Technologies

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Contract

$55 - $60

Operational Technology (OT) Cyber Security Architect

Remote or Maryland

•

Today

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description The Operational Technology (OT) Cyber Security Architect will serve as a senior authority driving the definition, composition, and implementation of security architectures across Thermo Fisher Scientific's manufacturing, laboratory, and R&D operations, as well as influencing the overall security of our enterprise corporate network. This role requires expertise in security principles and operations technology arch

Full-time

USD 143,000.00 - 190,600.00 per year

Systems Administrator

Remote or Tennessee

•

Today

It's More Than a Career, It's a Mission. Our people are the foundation of our success. By joining our growing team at Sarah Cannon Research Institute (SCRI), a subsidiary of McKesson, you will have the opportunity to become part of one of the largest community-based cancer programs to advance oncology treatments and improve outcomes for cancer patients across the globe. We look for mission-driven candidates who have a desire to advance the fight against cancer and make a difference in the lives

Full-time

Staff Software Quality Engineer

Remote or Santa Clara, California

•

Today

Full-time

USD 141,000.00 - 227,700.00 per year

Lead , Data & Platforms

Remote or Horsham, Pennsylvania

•

Today

Full-time

USD 91,000.00 - 147,200.00 per year

Manager, Data & Platforms

Remote or Horsham, Pennsylvania

•

Today

Full-time

USD 100,000.00 - 173,500.00 per year

Quality Control Analyst-W2-Medical deivces

Remote

•

8d ago

Title:QC Analyst Remote Design and configure analytical test methods in the EyeLab (LME) module of LabVantage LIMS. Collaborate with laboratory scientists and QA to translate SOPs and analytical procedures into executable LIMS workflows. Conduct method testing, validation, and troubleshooting in coordination with IT and LIMS administrators. Ensure all method executions comply with GMP, 21 CFR Part 11, and data integrity requirements. Prepare and maintain related documentation including URS, conf

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Contract

Depends on Experience

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21 CFR Part 11 jobs in Chicago, IL, USA