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Computer System Validation Jobs in Illinois (NOW HIRING)

Tempus

Senior Quality Engineer

Chicago, IL · On-site +1

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

Tempus

Senior Quality Engineer

Chicago, IL · On-site

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

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How much do computer system validation jobs pay per hour?

As of Jun 17, 2026, the average hourly pay for computer system validation in Illinois is $52.64, according to ZipRecruiter salary data. Most workers in this role earn between $40.53 and $62.40 per hour, depending on experience, location, and employer.

What are some typical challenges faced in Computer System Validation roles?

Professionals in Computer System Validation often encounter challenges such as keeping up with evolving regulatory requirements, ensuring complete and accurate documentation, and coordinating with cross-functional teams to implement validation protocols. Balancing thoroughness with project deadlines can also be demanding, as every validation step must stand up to external audits. However, these challenges provide valuable experience, strengthen project management abilities, and emphasize teamwork—key attributes that support career advancement into validation leadership or quality assurance roles.

What is a Computer System Validation job?

A Computer System Validation (CSV) job involves ensuring that computer systems used in regulated industries, such as pharmaceuticals and medical devices, meet compliance and regulatory requirements. CSV professionals develop and execute validation protocols to confirm that software, hardware, and processes function as intended and maintain data integrity. They work with quality assurance, IT, and regulatory teams to document compliance with standards like FDA 21 CFR Part 11 and GxP. This role is critical in maintaining system reliability, product quality, and patient safety.

What is the salary of computer system validation?

The salary for a Computer System Validation specialist typically ranges from $70,000 to $120,000 annually, depending on experience, location, and industry. Certifications such as GAMP or CSV training can influence earning potential, and roles often require knowledge of regulatory standards like FDA or ISO.

What are the key skills and qualifications needed to thrive in the Computer System Validation position, and why are they important?

To excel in Computer System Validation, candidates typically need a background in computer science, engineering, or life sciences, with expertise in validating software and systems in regulated environments such as pharmaceuticals or medical devices. Familiarity with tools like validation documentation software, GAMP 5 guidelines, FDA 21 CFR Part 11 regulations, and potentially certifications like CSV Professional or Six Sigma is highly valued. Strong attention to detail, analytical thinking, and effective communication skills help professionals work collaboratively and document findings precisely. These abilities ensure compliance, data integrity, and the reliability of computerized systems critical to safety and quality.

What is the work of computer system validation?

Computer System Validation (CSV) is the process of ensuring that computer systems used in regulated environments function correctly and comply with industry standards. It involves documenting and testing software, hardware, and related processes to verify they meet specified requirements, often using validation protocols and tools. CSV is essential in industries like pharmaceuticals and healthcare to ensure data integrity and compliance with regulations such as FDA or GMP.

Is computer system validation a good field?

Computer System Validation (CSV) is a vital part of regulated industries like pharmaceuticals and biotech, ensuring that computer systems meet quality and compliance standards. It often requires knowledge of regulatory guidelines, validation protocols, and tools like GxP and 21 CFR Part 11. The field offers steady demand, opportunities for certification, and roles in quality assurance and compliance management.

Is CSV a skill?

In the context of Computer System Validation, CSV refers to Computer System Validation itself, which is a process rather than a skill. However, skills related to CSV include understanding validation protocols, regulatory requirements, and proficiency with validation tools and documentation. These skills are essential for professionals performing CSV tasks in regulated industries like pharmaceuticals and biotech.
What are the most commonly searched types of Computer System Validation jobs in Illinois? The most popular types of Computer System Validation jobs in Illinois are:
What are popular job titles related to Computer System Validation jobs in Illinois? For Computer System Validation jobs in Illinois, the most frequently searched job titles are:
What job categories do people searching Computer System Validation jobs in Illinois look for? The top searched job categories for Computer System Validation jobs in Illinois are:
Computer System Validation jobs near you
Quality Assurance Specialist, Computer Software Validation

Quality Assurance Specialist, Computer Software Validation

MEITHEAL PHARMACEUTICALS INC

Chicago, IL • On-site

$78K - $86K/yr

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Posted 25 days ago

Job description

Job Type
Full-time
Description
Founded in 2017 and based in Chicago, Meitheal is focused on the development and commercialization of generic injectable medications and, as of 2022, has expanded its focus to include fertility, biologic, and branded products. Meitheal currently markets over 60 U.S. Food and Drug Administration (FDA)-approved products across numerous therapeutic areas including anti-infectives, oncolytic, intensive care, and fertility. As of January 2025, Meitheal, directly or through its partners, has 19 products in the research and development phase, 22 additional products planned for launch in 2025, and 24 products under review by the FDA. Meitheal's mission is to provide easy access to fairly priced products through robust manufacturing, consistent supply, and rapid response to our customers' needs. Ranked #2 in 2024 on Crain's Fast 50 in Chicago, and in the top 100 of Crain's Best Places to Work in Chicago from 2022 to 2024, Meitheal emulates the traditional Irish guiding principle we are named for - working together toward a common goal, for the greater good.
The estimated salary range for this position is $78,000 to $86,000 USD / year.
The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.
What We Offer
  • Competitive pay and medical, dental, and vision insurance
  • Flexible spending accounts
  • Long- and short-term disability insurance, as well as life insurance
  • 401(k) plan with employer contribution
  • Competitive PTO and company-paid holidays
  • Paid parental leave (maternity & paternity)
  • Onsite gym (Chicago office)

Position Summary
The Quality Assurance Specialist - CSV is responsible for Computer Software Validation and Assurance activities for Meitheal's GMP Computer Systems. This individual will be responsible for developing, updating and executing Software Lifecycle documents [Validation Plan, Qualification Protocols/Test Scripts, Risk Assessments, Validation Reports, Procedures, etc.] in accordance with their specified requirements and validated in accordance with FDA and other agency requirements.
Essential Duties and Responsibilities
  • Author/Update Computer System Validation deliverables, including Validation Plans, User Requirements Specifications, Functional Specifications, Testing Protocols (IQ/OQ/PQ), User Acceptance Testing, Traceability Matrix, Validation Reports, SOP's and Change Control Documentation.
  • Review of vendor provided validation documentation to determine suitability and alignment with company CSV SOPs and GAMP5.
  • Support the release updates for all GMP related computer systems.
  • Thorough knowledge of 21 CFR Part 11 (210, 211, 600, and 820), Data Integrity, GAMP5 requirements and FDA industry regulations.
  • Collaborate with the Process Owners SMEs to determine, and document, appropriate user requirements.
  • Apply FDA's new CSA guidelines to leverage risk-based strategy for testing to reduce documentation burdens while maintaining product quality and safety.
  • Participate in the development, implementation, and modification of Computer System Validation Standard Operating Procedures (SOP) based on current regulations and industry standards.
  • Work with QA to resolve any discrepancies or issues encountered during the validation of a computer system.
  • Support QA in periodic audits and inspections, ensuring that all validation documentation is audit ready.
  • Other duties, as assigned.

Competencies
  • Code of Federal Regulations and cGMP's relating to the field of Computer System Validation.
  • Ability to write technical documents (like Validation Plan, URS, FRS, Traceability Matrix, IQ/OQ protocol and report, etc.).
  • Strong verbal and written communication skills, good decision-making skills and time management skills are a must; ability to interface with all levels of the organization.
  • Ability to establish clear priorities quickly, work effectively under pressure, handle multiple projects and meet deadlines.
  • Ability to quickly learn and understand multiple types of software programs and/or SaaS applications including but not limited to QMS, ERP, Serialization, eCTD, Software Testing Tools ValGenesis) etc.

Position Requirements
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required.
  • Previous experience in writing, reviewing and executing computer validation documentation (VP, IQ, OQ, PQ, VSR).
  • Knowledge of cGMP, GDP, GAMP, 21CFR Part 11, Data Integrity and industry best practices.
  • Ability to understand existing and new business processes and requirements, to ensure proper implementation and validation of systems.
  • Experience with SaaS systems in GxP environment preferred.
  • ASQ, ISTQB Certification relevant to Software Quality Assurance is a plus.

Education and/or Experience
  • Degree (Bachelor's or Masters) in Computer Science, Software Engineering or other relevant Science Field or equivalent relevant experience.
  • 3+ years in a cGMP-related industry with Computer System Validation and 21 CFR Part 11 compliance.

Travel
  • No travel expected.

Physical Demands
  • While performing the duties of this Job, the employee is frequently required to stand; walk; sit and talk or hear. The employee must occasionally lift and/or move up to 20 pounds.

Computer Skills
  • Microsoft Office, Adobe Systems (Pro, Acrobat DC), TrackWise/TrackWise Digital, SAP, Docubridge, Software Testing Tools.

AAP/EEO Statement
Meitheal Pharmaceuticals is an Equal Opportunity Employer. We welcome and encourage applications from all qualified individuals, including minorities, women, veterans, and individuals with disabilities.
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