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Computer System Validation Engineer Jobs in Illinois

Tempus

Senior Quality Engineer

Chicago, IL · On-site +1

As a Senior Quality Engineer , you will: * Lead verification, validation and maintenance of host ... Lead computer system validation (CSV) activities of Tempus AI applications, software tools, and ...

Tempus

Senior Quality Engineer

Chicago, IL · On-site

As a Senior Quality Engineer , you will: * Lead verification, validation and maintenance of host ... Lead computer system validation (CSV) activities of Tempus AI applications, software tools, and ...

IT EXCEL LLC

Jr QA Tester

Sibley, IL

$55K - $58K/yr

... Computer System Validation. RELOCATION IS A MUST AND 4 WEEKS MANDATORY IN-PERSON TRAINING IN RESTON, VA Title: Jr. Validation Engineer/QA Analyst/ Jr. QA Tester/Business Analyst/BA Description : WE ...

IT EXCEL LLC

JR QA TESTER

Evanston, IL · On-site

$55K - $58K/yr

... Computer System Validation. RELOCATION IS A MUST AND 4 WEEKS MANDATORY IN-PERSON TRAINING IN RESTON, VA Title: Jr. Validation Engineer/QA Analyst/ Jr. QA Tester/Business Analyst/BA Description : WE ...

IT EXCEL LLC

Jr QA Tester

Sibley, IL · On-site

$55K - $58K/yr

... Computer System Validation. RELOCATION IS A MUST AND 4 WEEKS MANDATORY IN-PERSON TRAINING IN RESTON, VA Title: Jr. Validation Engineer/QA Analyst/ Jr. QA Tester/Business Analyst/BA Description : WE ...

IT EXCEL LLC

JR QA TESTER

Evanston, IL

$55K - $58K/yr

... Computer System Validation. RELOCATION IS A MUST AND 4 WEEKS MANDATORY IN-PERSON TRAINING IN RESTON, VA Title: Jr. Validation Engineer/QA Analyst/ Jr. QA Tester/Business Analyst/BA Description : WE ...

ARi

HIL Validation

Peoria, IL

$65K - $75K/yr

ARi is a fast-growing global engineering firm headquartered in East Peoria, IL, USA. Our power of ... Computer Science related fields Required Skills: Experience with HIL system testing and hardware ...

Alliant Credit Union

Lead Model Validation

Chicago, IL · Hybrid

$95K - $163K/yr

Validate a broad range of models used across credit risk, treasury management (ALM), finance ... Finance, Engineering, Computer Science or related * Preferred - Graduate Degree in Mathematics ...

Alliant

Lead Model Validation

Chicago, IL · On-site

$95K - $163K/yr

Validate a broad range of models used across credit risk, treasury management (ALM), finance ... Finance, Engineering, Computer Science or related * Preferred - Graduate Degree in Mathematics ...

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Computer System Validation Engineer information

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$73

How much do computer system validation engineer jobs pay per hour?

As of Jul 25, 2026, the average hourly pay for computer system validation engineer in Illinois is $50.20, according to ZipRecruiter salary data. Most workers in this role earn between $37.74 and $62.40 per hour, depending on experience, location, and employer.

What are some common challenges faced by Computer System Validation Engineers in regulated industries?

Computer System Validation Engineers often encounter challenges such as keeping up with evolving regulatory requirements, managing documentation for multiple systems, and ensuring timely validation while coordinating with cross-functional teams. Balancing strict compliance with project deadlines can be demanding, especially when systems are complex or legacy infrastructure is involved. Additionally, effective communication with IT, QA, and business stakeholders is essential to address issues quickly and maintain validation standards.

What does a computer system validation engineer do?

A computer system validation engineer ensures that computer systems used in regulated industries meet required standards for quality, safety, and compliance. They develop validation protocols, perform testing, document results, and ensure systems function correctly according to regulatory guidelines such as FDA or GMP. This role often involves working with validation tools, risk assessments, and maintaining detailed documentation to support audits and inspections.

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

To thrive as a Computer System Validation Engineer, you need a solid background in computer science or engineering, knowledge of regulatory requirements (such as FDA or GxP), and experience in validation processes. Familiarity with validation tools, quality management systems, and documentation software is typically required, along with certifications like ISPE or ASQ being beneficial. Strong attention to detail, analytical thinking, and effective communication are essential soft skills for coordinating teams and ensuring compliance. These skills and qualities are crucial to ensure that computer systems meet regulatory standards, maintain data integrity, and support business operations in regulated industries.

What is the difference between Computer System Validation Engineer vs Quality Assurance Specialist?

AspectComputer System Validation EngineerQuality Assurance Specialist
CertificationsGAMP, GxP validation certificationsISO, Six Sigma, GMP certifications
Work EnvironmentPharmaceutical, biotech, medical device industriesManufacturing, software, healthcare sectors
Primary FocusValidating computer systems and software complianceEnsuring overall quality and process improvements

The Computer System Validation Engineer primarily focuses on validating computer systems to meet regulatory standards, ensuring software compliance in regulated industries. In contrast, the Quality Assurance Specialist oversees broader quality processes, including audits and process improvements. Both roles require knowledge of industry regulations but differ in scope and specific responsibilities.

What is the salary of SoC validation engineer?

The salary of a System on Chip (SoC) validation engineer typically ranges from $80,000 to $130,000 annually, depending on experience, location, and company size. Entry-level positions may start lower, while experienced engineers with specialized skills in hardware description languages and verification tools can earn higher salaries.

What is the salary of a CSV engineer?

The salary of a Computer System Validation (CSV) Engineer typically ranges from $70,000 to $120,000 annually, depending on experience, location, and certifications such as GxP or 21 CFR Part 11. Senior roles or those in high-cost-of-living areas may offer higher compensation, and knowledge of validation tools like MasterControl or ValGenesis can enhance earning potential.

Is computer system validation a good field?

Computer System Validation (CSV) is a vital field in regulated industries like pharmaceuticals and biotech, ensuring software and systems meet compliance standards such as 21 CFR Part 11. It offers stable job opportunities, requires knowledge of validation protocols, and often involves working with tools like GxP guidelines and validation documentation. The field is considered stable and growing due to ongoing regulatory requirements.
What are popular job titles related to Computer System Validation Engineer jobs in Illinois? For Computer System Validation Engineer jobs in Illinois, the most frequently searched job titles are:
What job categories do people searching Computer System Validation Engineer jobs in Illinois look for? The top searched job categories for Computer System Validation Engineer jobs in Illinois are:
Computer System Validation Engineer jobs near you
Infographic showing various Computer System Validation Engineer job openings in Illinois as of July 2026, with employment types broken down into 1% As Needed, 87% Full Time, 10% Part Time, and 2% Contract. Highlights an 82% Physical, 1% Hybrid, and 17% Remote job distribution, with an average salary of $104,410 per year, or $50.2 per hour.
Senior Quality Engineer

Senior Quality Engineer

Tempus

Chicago, IL • On-site, Remote

Full-time

Posted 21 days ago

Job description

Passionate about precision medicine and advancing the healthcare industry?

Recent advancements in underlying technology have finally made it possible for AI to impact clinical care in a meaningful way. Tempus' proprietary platform connects an entire ecosystem of real-world evidence to deliver real-time, actionable insights to physicians, providing critical information about the right treatments for the right patients, at the right time.

PLEASE NOTE: This is a hybrid role requiring three days a week in the office. Candidates can be based out of our Chicago (Headquarters), New York, or Redwood City locations.

As a Senior Quality Engineer, you will:

  • Lead verification, validation and maintenance of host systems supporting Tempus Medical Device(s).

  • Lead risk assessments to determine testing strategies.

  • Be involved in the medical device software design controls activities, in accordance with the FDA Quality System Regulation, ISO 13485, GAMP5, Computer System Validation (CSV) standards and FDA guidance, other applicable regulatory requirements, as well as best practices in the software industry.

  • Lead computer system validation (CSV) activities of Tempus AI applications, software tools, and computer systems against user, functional and regulatory requirements.

Responsibilities:

  • Support regulatory compliance of the host system operating with Tempus Medical Device(s).

  • Develop and maintain CSV policies, procedures, templates and work instructions.

  • Lead risk-based approach to host / computer system validation (HSV/CSV), SDLC and design controls activities.

  • Perform validation, re-validation and change controls of various AI, SaaS, and Tempus in-house developed software.

  • Author and review software validation deliverables, including Risk Assessments, Validation Plans, Requirements (URS), Validation Protocols (IQ, OQ, PQ), UAT (User Acceptance Test), and Validation Reports.

  • Collaborate with cross-functional teams in developing test-driven system/functional requirements, defining testing strategies and participating in test execution.

  • Support Change Management and Major Incidents (MI) processes, ensuring organizational compliance and continuous improvement.

  • Provide support to Quality and IT organizations in maintaining compliance to various policies, procedures and activities, including support during internal/external inspections and regulatory and customer audits.

  • Provide CSV guidance, coaching, mentorship, and training to test engineers within the team.

Qualifications

  • BA/B.S. or higher preferred in Computer Science, Software Engineering, Informatics, Biomedical, or relevant engineering disciplines.

  • 5+ years experience in FDA regulated domain (e.g. medical device, pharma, biotech)

  • 3+ years experience in Computer System Validation (CSV).

  • Experience with industry standards and best practices for Medical device software and CSV such as Design Controls, GAMP 5, FDA 21 CFR Part 11, FDA (QSR) FDA 21 CFR 820.30, Medical device software (QMS) ISO 13485:2016, FDA 21 CFR 820, and Software life cycle processes (IEC 62304:2006).

  • Knowledge of quality system principles, practices, and standards for the life science industry.

  • Ability to deliver quality outputs without directions or under minimal supervision.

Chicago Pay Range: $90,000-$130,00

NYC/SF Pay Range: $100,000-$150,000

The expected salary range above is applicable if the role is performed from California and may vary for other locations (Colorado, Illinois, New York). Actual salary may vary based on qualifications and experience. Tempus offers a full range of benefits, which may include incentive compensation, restricted stock units, medical and other benefits depending on the position.

Additionally,for remote roles open to individuals in unincorporated Los Angeles - including remote roles-Tempus reasonably believes that criminal history may have a direct, adverse and negative relationship on the following job duties, potentially resulting in the withdrawal of the conditional offer of employment: engaging positively with customers and other employees; accessing confidential information, including intellectual property, trade secrets, and protected health information; and appropriately handling such information in accordance with legal and ethical standards. Qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable law, including the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.

We are an equal opportunity employer. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

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