21 CFR Part 11 jobs in Chicago, IL

Remote or Queens, New York

•

Today

Title - CSA Validation Subject Matter Expert (SME) Contract- 6+ months C2 Mode of Interview - Video Working in the security organization at ELC Must Have: Extensive experience in the Medical, Pharma or Regulatory Compliance Industries Strong CSA experience as they will be acting as the SME Must have good communication and leadership skills, collaboration skills, must have a positive attitude and be easy to work with Agile experience/knowledge highly preferred. The CSA Validation SME is a

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Contract, Third Party

$DOE

GxP Lab Computing Engineer with pharma exp

Chicago, Illinois

•

Today

Job Title: GxP Lab Computing Engineer with pharma exp Location: & 1401 N. Sheridan Rd. North Chicago IL 60064 - locals only The Lab Computing Engineer provides both consulting, analytical and technical laboratory services, including multivendor instrument, information technology as well as in-lab validation/compliance services when applicable. The individual will provide the consulting skills required to analyze customer needs and gaps to propose solutions for the desired state. He or she will

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Contract, Third Party

$50+

LIMS Consultant

Remote

•

Yesterday

We are seeking a LIMS Specialist to manage, configure, and support our Laboratory Information Management System (LIMS). The role ensures smooth lab operations, data integrity, and regulatory compliance across all testing workflows. Key Responsibilities: Configure and maintain LIMS master data, workflows, and user access.Support implementation, validation (IQ/OQ/PQ), and system upgrades.Troubleshoot issues and coordinate with IT/vendors for resolution.Ensure compliance with GxP, 21 CFR Part 11, a

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Contract, Third Party

$60 - $70

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

Empower CDS Administrator

Remote

•

Today

Empower CDS Administrator Direct-Hire / FTE with WinWire REMOTE / Work From Home We are seeking an experienced professional to manage and support Waters Empower Chromatography Data System (CDS), oversee laboratory instrument integration, perform troubleshooting, and ensure system compliance with GxP and 21 CFR Part 11 regulatory requirements. The role also involves Computer System Validation (CSV), administration, and continuous improvement of laboratory informatics systems. Skills/Experience 3

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Full-time

Depends on Experience

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

Remote

•

26d 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 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

Contract, Third Party

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

Application Analyst IV

Remote

•

Today

Immediate need for a talented Application Analyst IV. This is a 12 months contract opportunity with long-term potential and is located in U.S(Remote). Please review the job description below and contact me ASAP if you are interested. Job ID:25-90333 Pay Range: $60 - $70/hour. Employee benefits include, but are not limited to, health insurance (medical, dental, vision), 401(k) plan, and paid sick leave (depending on work location). Key Responsibilities: The ideal candidate will have strong progr

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Contract

$60 - $70

Operational Technology (OT) Cyber Security Architect

Remote or Maryland

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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

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

Cybersecurity Architect

Remote or Cleveland, Ohio

•

Today

At Cleveland Clinic Health System, we believe in a better future for healthcare. And each of us is responsible for honoring our commitment to excellence, pushing the boundaries and transforming the patient experience, every day. We all have the power to help, heal and change lives - beginning with our own. That's the power of the Cleveland Clinic Health System team, and The Power of Every One. Job Title Cybersecurity Architect Location Cleveland Facility Remote Location Department Cybersecurit

Full-time

Principal Agentic AI Chatbot Engineer

Remote or Thousand Oaks, California

•

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 189,750.00 per year

Principal SAP Architect, Enterprise Asset Management (EAM)

Remote

•

Today

Full-time

USD 154,142.00 per year

Computer System Validation (CSV) Engineer

Remote or Massachusetts

•

Today

Responsibilities: Lead and execute CSV activities across GxP-regulated systems (LIMS, MES, ERP, etc. uthor and maintain validation deliverables: URS, FS, DS, IQ, OQ, PQ, and traceability matrices. Ensure systems comply with 21 CFR Part 11, EU Annex 11, and GAMP 5. Support system implementations, upgrades, and periodic reviews. Collaborate with QA, IT, and business users to drive validation strategy. Participate in audits and inspections to demonstrate compliance. Requirements: Bachelor's degree

Full-time

LIMS and QC Applications Consultant

Remote or Hybrid in Bridgewater, New Jersey

•

Today

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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Full-time, Contract

BASED ON EXPERIENCE

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21 CFR Part 11 jobs in Chicago, IL, USA