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Computer System Validation Csv Jobs in Illinois (NOW HIRING)

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

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

Sr. Validation Lead

Chicago, IL · On-site

$120 - $170/hr

This position requires a senior-level individual with strong experience in supporting computer system validation (CSV) efforts for applications used in GMP, GLP and/or GCP processes ensuring ...

This is a project-based role focused on Computer System Validation, also known as CSV, and Computer Software Assurance, also known as CSA. The contractor will support requirements documentation, PLM ...

IL · On-site

Familiarity with computerized systems validation (CSV), cleaning validation, or utility qualification is an added advantage. I am actively connecting with professionals for current and upcoming ...

Bachelor's degree in business, information systems, computer science, engineering, or equivalent experience; 6+ years of experience in computer system validation in a life sciences environment ...

Bachelor's degree in business, information systems, computer science, engineering, or equivalent experience; 6+ years of experience in computer system validation in a life sciences environment ...

Bachelor's degree in business, information systems, computer science, engineering, or equivalent experience; 6+ years of experience in computer system validation in a life sciences environment ...

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Computer System Validation Csv information

See Illinois salary details

$28

$50

$73

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

As of Sep 7, 2026, the average hourly pay for computer system validation csv 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 is a computer system validation CSV?

A Computer System Validation (CSV) job involves ensuring that computerized systems used in regulated industries, such as pharmaceuticals and medical devices, comply with industry standards and regulatory requirements (e.g., FDA 21 CFR Part 11, GxP). CSV professionals develop validation protocols, conduct testing, and document system performance to ensure data integrity, reliability, and compliance. Their role is critical in maintaining system quality and avoiding regulatory risks.

What are the key skills and qualifications needed to thrive in computer system validation CSV?

To thrive as a Computer System Validation (CSV) professional, you need a solid understanding of computer science, regulatory compliance (such as FDA 21 CFR Part 11), and validation methodology, often supported by a degree in a scientific or technical field. Familiarity with documentation tools, validation protocols, and quality management systems, as well as certifications like PMP or Six Sigma, is highly beneficial. Strong attention to detail, problem-solving abilities, and effective communication skills enable effective cross-functional collaboration. Mastering these skills ensures accurate validation processes, regulatory compliance, and smooth project execution in highly regulated environments.

What are some typical challenges faced by computer system validation CSV professionals and how are they addressed?

Computer System Validation (CSV) professionals often encounter challenges such as keeping up with evolving regulations, managing complex documentation requirements, and ensuring robust communication between IT, quality assurance, and business teams. Navigating system upgrades while maintaining compliance with strict regulatory standards requires careful planning and thorough risk assessment. Successful candidates address these challenges by staying current with industry guidance, utilizing validation templates and checklists, and fostering strong teamwork across various departments. Building collaborative relationships and maintaining meticulous records help ensure both audit readiness and smooth project completion.

Is computer system validation a good field?

Computer System Validation (CSV) is a specialized field within regulated industries like pharmaceuticals and biotech, focusing on ensuring software and systems meet compliance standards such as GxP. It offers opportunities for professionals with skills in quality assurance, validation protocols, and regulatory requirements, often requiring certifications like GAMP or 21 CFR Part 11 knowledge. The field provides stable employment with growth potential, especially as compliance regulations become more stringent.

What are the most commonly searched types of Computer System Validation Csv jobs in Illinois?

The most popular types of Computer System Validation Csv jobs in Illinois are:

What are popular job titles related to Computer System Validation Csv jobs in Illinois?

For Computer System Validation Csv jobs in Illinois, the most frequently searched job titles are:

What job categories do people searching Computer System Validation Csv jobs in Illinois look for?

The top searched job categories for Computer System Validation Csv jobs in Illinois are:

Infographic showing various Computer System Validation Csv job openings in Illinois as of August 2026, with employment types broken down into 1% As Needed, 87% Full Time, 10% Part Time, and 2% Contract. Highlights an 91% Physical, 3% Hybrid, and 6% Remote job distribution, with an average salary of $104,410 per year, or $50.2 per hour.

Senior Quality Engineer

Tempus

Chicago, IL • On-site

Full-time

Re-posted 5 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) or Aliso Viejo, California office.
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.