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Computer System Validation Jobs in Illinois (NOW HIRING)

Belcan

Test Validation Engineer

Mossville, IL

$50/hr

... Mechanical, Computer Engineeri ng or related fie * ld4+ yea rs of experience i n system integration & validation (embedded systems preferre * d)Hands-on experience wit h machine/system setup ...

IT EXCEL LLC

Jr QA Tester

Sibley, IL · On-site

$55K - $58K/yr

We specialize in the following technologies- QA/Software Testing, Business Analysis and Computer System Validation. RELOCATION IS A MUST AND 4 WEEKS MANDATORY IN-PERSON TRAINING IN RESTON, VA Title ...

IT EXCEL LLC

JR QA TESTER

Evanston, IL

$55K - $58K/yr

We specialize in the following technologies- QA/Software Testing, Business Analysis and Computer System Validation. RELOCATION IS A MUST AND 4 WEEKS MANDATORY IN-PERSON TRAINING IN RESTON, VA Title ...

IT EXCEL LLC

Jr QA Tester

Sibley, IL

$55K - $58K/yr

We specialize in the following technologies- QA/Software Testing, Business Analysis and Computer System Validation. RELOCATION IS A MUST AND 4 WEEKS MANDATORY IN-PERSON TRAINING IN RESTON, VA Title ...

IT EXCEL LLC

JR QA TESTER

Evanston, IL · On-site

$55K - $58K/yr

We specialize in the following technologies- QA/Software Testing, Business Analysis and Computer System Validation. RELOCATION IS A MUST AND 4 WEEKS MANDATORY IN-PERSON TRAINING IN RESTON, VA Title ...

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How much do computer system validation jobs pay per hour?

As of Jun 18, 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

Global QMS Information Systems Lead

Hollister Incorporated

Libertyville, IL • On-site, Remote

Other

Medical, Dental, Vision, Life, Retirement, PTO

Posted 12 days ago

Abercrombie & Fitch rating

6.2

Company rating: 6.2 out of 10

Based on 154 frontline employees who took The Breakroom Quiz

48th of 102 rated fashion retailers

Job description

We Make Life More Rewarding and Dignified 

Location: Libertyville
Department: Quality 

Summary

The Global QMS Information Systems Lead is responsible for leading the global strategy, implementation, and continuous improvement of the electronic Quality Management System (eQMS) and related digital systems. This involves ensuring these systems are properly designed, installed, and maintained to meet established user needs, functional specifications, and all applicable regulatory requirements (e.g., ISO 13485, GAMP 5, IEC 62304, FDA QSR, 21 CFR Part 11), minimizing risks to data integrity, product safety and efficacy, enabling data integrity, process efficiency, traceability, and global collaboration.

This role has direct involvement with the introduction and maintenance of global software systems utilized to support the global QMS. Additionally, as a Quality Assurance representative, this position will support delivery of quality system software application validations (inclusive of developing and executing validation plans, protocols and testing documentation) in collaboration with IT and system owner cross functional teams to ensure effective and compliant computerized systems. This role will also support the ongoing maintenance of computerized systems at Hollister Incorporated and will support investigations, resolve potential data integrity issues, and implement process improvements to mitigate any risks to the validated state.

Responsibilities

 

  • Develop and manage the global eQMS roadmap, including system enhancements, integrations, and harmonization across regions
  • Ensure alignment with regulatory frameworks (e.g., ISO 13485, FDA QSR, EU MDR)
  • Implement, configure, and maintain modules (e.g., Document Control, CAPA, Change Control, training, complaint handling, supplier quality)
  • Collaborate with IT to validate critical computerized systems per applicable regulatory documentation/control requirements
  • Map and optimize QMS workflows to streamline global processes and eliminate redundancy
  • Support digital traceability and integration of eQMS with ERP, PLM, MES systems
  • Maintain regulatory compliance through system readiness and audit support, ensuring regulatory preparedness with system validation documentation, audit trails, etc.
  • Manage large-scale projects, system implementations, and third-party vendor relationships
  • Deliver global training for users and administrators on eQMS functionality and compliance
  • Evaluate and implement new digital solutions (e.g., AI, cloud) to enhance efficiency and data utilization
  • Provide guidance and actively participate as a project team member for software validation projects
  • Generation/maintenance of software validation plans, protocols and reports to applicable standards and industry best practices
  • Review / approval of software validation plans, requirements, protocols/ test scripts and final reports.
Essential Functions of the Role
  • Communicate effectively via email, phone, and virtual platforms.
  • Collaborate across departments to support organizational goals.
  • Participate in cross-functional meetings and initiatives.
  • Maintain and analyze data using tools like Excel, SAP, or HRIS systems.
  • Prepare reports and dashboards for internal stakeholders.
  • Ensure data accuracy and confidentiality in compliance with company and legal standards.
  • Manage multiple priorities and deadlines in a fast-paced environment.
  • Lead or support special projects aligned with departmental objectives.
  • Demonstrate initiative in identifying process improvements or automation opportunities.
  • Serve as a point of contact for internal and external stakeholders.
  • Resolve inquiries and issues with professionalism and discretion.
  • Maintain secure handling of sensitive information.
  • Support audits and regulatory reporting as needed.
Education & Work Requirements
  • Bachelor's Degree with 8-12 years of related experience
Education & Work Preferences
  • Experience in deploying and managing eQMS platforms (e.g., TrackWise, MasterControl, Veeva) and their integration with enterprise systems
  • Experience in deploying and managing eQMS platforms (e.g., TrackWise, MasterControl, Veeva) and their integration with enterprise systems
    • Understanding of 21 CFR 11 validation, Computer System Validation (CSV), and software regulatory requirements
    • Proficient in system administration and design thinking - process mapping, gap analysis, data integrity assurance
    • Spreadsheet Validation
    • Risk-based planning, testing (IQ/OQ/PQ), detailed documentation, change control around computer systems for quality, manufacturing, and device function to ensure they're safe, reliable, and compliant 
    • Procedural documentation development pertinent to Computer System Validation
    • Extensive experience in medical device IT, Quality Systems, or Digital Health
    • Deep understanding of medical device regulations (e.g., ISO 13485, ISO 14971, EU MDR 2017/745, MDSAP)
    • Proficiency with relevant software, data management, cybersecurity, and digital platforms
    •  
Competencies
  • Be Agile - Innovates and adapts quickly, approaching change with curiosity while persisting through obstacles.
  • Be Customer Centric - Considers the needs, experiences and feedback of customers in all we do.
  • Be People-Focused - Builds trust and collaborates with an inclusive and empathetic approach.
  • Be Performance Driven - Operates with an ownership mindset, driving meaningful outcomes.
  • Live The Schneiders' Legacy, Our Noble Purpose - Passionately serves Our Mission and Vision, while demonstrating the Immutable Principles.

Our Total Rewards package in aggregate is above market and includes competitive pay, paid time off programs, peer-to-peer recognition, health and life insurance, wellness programs and incentives, and generous retirement savings.

  • The anticipated base pay range for this position is $108,000 - $155,000 yearly. The actual salary varies based on applicant's location, education, experience, skills, abilities, and other legitimate business factors.
  • This position is also eligible to participate in the Hollister Corporate Bonus Plan.
  • The Company's health and welfare benefits include medical, prescription, dental, vision, spending/savings accounts, disability, company paid (parental and caregiver) leaves, statutory leaves/disability programs, accident, life, wellbeing, education assistance, adoption assistance, and voluntary benefit programs.
  • The Company's 401(k) Retirement Savings Plan includes: auto-enrollment, ROTH, vesting and eligible participants "safe harbor" matching contributions.
  • The Company's paid time off benefits include: 11 paid holidays, paid vacation based on length of service and exempt/non-exempt status, and sick days based on statutory requirements and/or exempt/non-exempt status.
  • The Company's additional benefits include: education assistance and adoption assistance benefit programs. 

About Hollister Incorporated
Hollister Incorporated is an independent, employee-owned company that develops, manufactures and markets healthcare products worldwide. The company spearheads the advancement of innovative products for ostomy care, continence care and critical care, and also creates educational support materials for patients and healthcare professionals. Headquartered in Libertyville, Illinois, Hollister has manufacturing and distribution centers on three continents and sells in nearly 80 countries. Hollister is a wholly owned subsidiary of The Firm of John Dickinson Schneider, Inc., and is guided both by its Mission to make life more rewarding and dignified for people who use our products and services, as well as its Vision to grow and prosper as an independent, employee-owned company, and in the process, to become better human beings.

EOE Statement
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

Job Req ID: 35988

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