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Computer System Validation Manager Jobs in Chicago, IL

IT EXCEL LLC

JR QA TESTER

Evanston, IL

$55K - $58K/yr

... Analysis and Computer System Validation. RELOCATION IS A MUST AND 4 WEEKS MANDATORY IN-PERSON ... management levels, technical dependencies, timeline impact and risks Employment Benefits ...

IT EXCEL LLC

JR QA TESTER

Evanston, IL · On-site

$55K - $58K/yr

... Analysis and Computer System Validation. RELOCATION IS A MUST AND 4 WEEKS MANDATORY IN-PERSON ... management levels, technical dependencies, timeline impact and risks Employment Benefits ...

Saxon Global

Validation QA Analyst

Lake Forest, IL

Must Haves: Experience with validation systems critical IQ, PQ, OQ GxP Principles 21 CFR Pt 11 ... Coordinate with IT, QA and applicable business unit management in the training on testing policies ...

Automated Systems, Inc.

Be Seen First

Validation Engineer

Chicago, IL · On-site

$45 - $65/hr

... systems, including document management (e.g., OneVault), change management (e.g., OneTrack), investigations/CAPA (e.g., TrackWise), and validation execution platforms (e.g., Kneat) or equivalent ...

Ankura

Model Validation Director

Chicago, IL · On-site +1

The Model Validation Director is expected to lead and execute model validation testing processes on ... Computer Science, Management Information Systems, or Statistics/Mathematics. * Experience with data ...

Argentum Medical

Validation Engineer

Geneva, IL · On-site

$110K - $130K/yr

Project Management * Automation - Robotics & Manufacturing Cells * Sterilization Processes ... Familiar with e-QMS systems such as QT9 POSITION SUMMARY: Oversees and executes design and process ...

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All JobsComputer System Validation JobsComputer System Validation Manager JobsComputer System Validation Manager Jobs in Chicago, IL

Computer System Validation Manager information

See Chicago, IL salary details

$48.9K

$108.6K

$165.3K

How much do computer system validation manager jobs pay per year?

As of Jun 9, 2026, the average yearly pay for computer system validation manager in Chicago, IL is $108,593.00, according to ZipRecruiter salary data. Most workers in this role earn between $76,700.00 and $136,000.00 per year, depending on experience, location, and employer.

What are the key skills and qualifications needed to thrive as a Computer System Validation Manager, and why are they important?

To thrive as a Computer System Validation Manager, you need expertise in computer system validation regulations (such as GxP, FDA 21 CFR Part 11), strong project management skills, and a background in life sciences or IT. Familiarity with validation lifecycle documentation tools, quality management systems (QMS), and compliance software is often required, along with relevant certifications like PMP or CSV-related credentials. Exceptional attention to detail, analytical thinking, and effective communication are crucial soft skills for coordinating cross-functional teams and ensuring regulatory compliance. These skills and qualifications are vital to ensure validated systems meet regulatory standards, minimize compliance risks, and support organizational quality objectives.

What are some common challenges a Computer System Validation Manager faces during system implementation projects?

A Computer System Validation Manager often encounters challenges such as aligning validation activities with evolving regulatory requirements, managing tight project timelines, and coordinating between multiple stakeholders like IT, Quality Assurance, and business users. Ensuring thorough documentation and traceability, while adapting to technology updates or scope changes, can also be demanding. Proactive communication and strong project management skills are essential to mitigate risks and ensure successful, compliant system implementations.

What does a Computer System Validation Manager do?

A Computer System Validation Manager is responsible for ensuring that computer systems used in regulated industries, such as pharmaceuticals or biotechnology, meet all required compliance standards. They oversee the planning, execution, and documentation of validation activities to ensure systems are reliable, accurate, and secure. Their duties include managing validation projects, writing protocols, coordinating with IT and quality assurance teams, and ensuring adherence to regulations like FDA 21 CFR Part 11. This role is critical for maintaining product quality and regulatory compliance.

What is the difference between Computer System Validation Manager vs Computer System Validation Specialist?

AspectComputer System Validation ManagerComputer System Validation Specialist
CertificationsGAMP, CQE, CSQEGAMP, CQE, CSQE
Work EnvironmentManagement, oversight, strategic planningExecution, testing, documentation
Industry UsagePharmaceutical, biotech, regulated industriesPharmaceutical, biotech, regulated industries
Primary FocusLeading validation projects, team coordinationPerforming validation activities, testing

The main difference between a Computer System Validation Manager and a Computer System Validation Specialist lies in their roles. The manager oversees validation projects, manages teams, and ensures compliance, while the specialist executes validation tasks and documents testing procedures. Both roles require similar certifications and are vital in regulated industries like pharmaceuticals and biotech.

What are the most commonly searched types of Computer System Validation jobs in Chicago, IL? The most popular types of Computer System Validation jobs in Chicago, IL are:
What are popular job titles related to Computer System Validation Manager jobs in Chicago, IL? For Computer System Validation Manager jobs in Chicago, IL, the most frequently searched job titles are:
What job categories do people searching Computer System Validation Manager jobs in Chicago, IL look for? The top searched job categories for Computer System Validation Manager jobs in Chicago, IL are:
What cities near Chicago, IL are hiring for Computer System Validation Manager jobs? Cities near Chicago, IL with the most Computer System Validation Manager job openings:
Computer System Validation Manager jobs near you
Reliability & Validation Engineer (Medical Devices) - Hybrid

Reliability & Validation Engineer (Medical Devices) - Hybrid

DivIHN Integration Inc

Deerfield, IL • On-site

Other

Posted 11 days ago

Job description

For further inquiries regarding the following opportunity, please contact our Talent Specialist
Kunal at 224-704-1709

Title: Reliability & Validation Engineer (Medical Devices) - Hybrid
Location: Deerfield, IL
Duration: 10 Months
Description:
Job Summary
We are seeking a Reliability Performance Engineer to develop and execute testing documentation and scripts that validate and verify both physical and digital Client's medical products. This role will be responsible for designing, implementing, and managing test protocols that ensure product reliability, security, and performance under various conditions, including high-volume simulations, network interactions, and cybersecurity challenges. The ideal candidate has a strong background in test automation, system validation, and compliance-driven testing within the medical device industry.
Key Responsibilities
Test Development & Execution
Create detailed test plans, scripts, and protocols to validate software, firmware, and hardware components of Client's medical devices.
Develop and automate tests that simulate high-volume data processing, real-world network interactions, and security threats.
Conduct functional, integration, and system-level testing to ensure compliance with regulatory and industry standards.
Perform manual and automated testing for both digital (software-based) and physical (hardware-based) products.
Simulation & Performance Testing
Design and execute high-volume simulations to evaluate device performance under extreme workloads.
Validate network reliability by simulating real-world connectivity scenarios, including cloud, IoT, and hospital network environments.
Conduct cybersecurity testing, including penetration testing, encryption validation, and threat modeling.
Data Analysis & Reporting
Analyze test results, identify failure points, and collaborate with R&D, engineering, and security teams for issue resolution.
Document testing methodologies, defects, and performance metrics in compliance with FDA, ISO 13485, IEC 62304, and HIPAA regulations.
Support root cause analysis (RCA) and corrective/preventive actions (CAPA) based on test findings.
Collaboration & Continuous Improvement
Work closely with software developers, network engineers, and product designers to refine product testing approaches.
Develop and maintain automated test frameworks for continuous integration/continuous deployment (CI/CD).
Stay updated on medical device regulations, cybersecurity best practices, and emerging testing technologies.
Qualifications & Skills
Required:
Bachelor's or Master's degree in Computer Science, Electrical Engineering, Biomedical Engineering, or related field.
years of experience in software/hardware testing, automation, or medical device validation.
Strong knowledge of test scripting languages (Python, Java, C#, or similar).
Experience with test management tools (e.g., TestRail, JIRA, Selenium, Appium, Cypress).
Familiarity with network protocols, security testing, and performance benchmarking.
Understanding of FDA 21 CFR Part 820, ISO 14971 (Risk Management), and IEC 60601 standards.
Preferred:
Experience with cloud-based medical device testing (AWS, Azure, IoT platforms).
Knowledge of cybersecurity frameworks (NIST, OWASP, FIPS 140-2).
Certification in ISTQB, CISSP, or Certified Ethical Hacker (CEH).

About us:
DivIHN, the 'IT Asset Performance Services' organization, provides Professional Consulting, Custom Projects, and Professional Resource Augmentation services to clients in the Mid-West and beyond. The strategic characteristics of the organization are Standardization, Specialization, and Collaboration.

DivIHN is an equal opportunity employer. DivIHN does not and shall not discriminate against any employee or qualified applicant on the basis of race, color, religion (creed), gender, gender expression, age, national origin (ancestry), disability, marital status, sexual orientation, or military status.