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Senior Computer System Validation Csv Jobs in Chicago, IL

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 ...

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 ...

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 ...

Drive validation and compliance activities for complex GxP systems as a Senior Consultant ... Bachelor's degree in business, information systems, computer science, engineering, or equivalent ...

Drive validation and compliance activities for complex GxP systems as a Senior Consultant ... Bachelor's degree in business, information systems, computer science, engineering, or equivalent ...

Drive validation and compliance activities for complex GxP systems as a Senior Consultant ... Bachelor's degree in business, information systems, computer science, engineering, or equivalent ...

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Senior Computer System Validation Csv information

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$35

$66

$101

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

As of Aug 31, 2026, the average hourly pay for senior computer system validation csv in Chicago, IL is $66.72, according to ZipRecruiter salary data. Most workers in this role earn between $53.22 and $75.77 per hour, depending on experience, location, and employer.

What is a senior computer system validation (CSV) specialist?

A Senior Computer System Validation (CSV) specialist is an experienced professional responsible for ensuring that computer systems used in regulated industries—such as pharmaceuticals, biotechnology, or medical devices—meet compliance standards. This involves planning, executing, and documenting validation activities to demonstrate that systems consistently perform according to predefined specifications and regulatory requirements. Senior CSV specialists often lead validation projects, manage teams, and interact with regulatory auditors, making sure that systems are reliable, secure, and compliant with guidelines like FDA 21 CFR Part 11 and GxP. Their expertise helps organizations avoid compliance issues, data integrity problems, and costly system failures.

What are the key skills and qualifications needed to thrive as a senior computer system validation (CSV) professional?

To excel as a Senior Computer System Validation (CSV) professional, you need deep knowledge of regulatory compliance (such as FDA 21 CFR Part 11), validation lifecycle methodologies, and a background in computer science, engineering, or life sciences. Familiarity with validation management tools, risk assessment software, and quality management systems (QMS) is typically required, along with certifications like GAMP or Six Sigma being highly valued. Outstanding analytical skills, attention to detail, and strong communication abilities set high performers apart in this role. These competencies ensure validated systems meet regulatory requirements, maintain data integrity, and support quality operations in regulated industries.

What are some common challenges senior computer system validation (CSV) professionals face when working on large-scale projects?

Senior CSV professionals often encounter challenges such as coordinating validation activities across multiple departments, managing evolving regulatory requirements, and ensuring thorough documentation throughout the project lifecycle. They also need to balance project timelines with the need for comprehensive testing and risk assessments. Effective communication and collaboration with IT, QA, and business stakeholders are essential to address issues proactively and ensure compliance in complex, regulated environments.

What is the difference between Senior Computer System Validation Csv vs Computer System Validation Specialist?

AspectSenior Computer System Validation CsvComputer System Validation Specialist
CertificationsGxP, 21 CFR Part 11, CSV certificationsGxP, 21 CFR Part 11, CSV certifications
Work EnvironmentRegulated industries like pharma, biotech, medical devicesRegulated industries like pharma, biotech, medical devices
ResponsibilitiesLeading validation projects, ensuring compliance, mentoringExecuting validation activities, documentation, testing

While both roles require similar certifications and work in regulated environments, the Senior Computer System Validation Csv typically involves leading projects and overseeing compliance efforts, whereas the Computer System Validation Specialist focuses on executing validation tasks and documentation. The senior role often requires more experience and leadership responsibilities.

What are the most commonly searched types of Computer System Validation Csv jobs in Chicago, IL?

The most popular types of Computer System Validation Csv jobs in Chicago, IL are:

What are popular job titles related to Senior Computer System Validation Csv jobs in Chicago, IL?

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

What job categories do people searching Senior Computer System Validation Csv jobs in Chicago, IL look for?

The top searched job categories for Senior Computer System Validation Csv jobs in Chicago, IL are:

What cities near Chicago, IL are hiring for Senior Computer System Validation Csv jobs?

Cities near Chicago, IL with the most Senior Computer System Validation Csv job openings:

Computer Systems Validation Specialist - PLM Implementation

System One

Cary, IL • Remote

$44 - $48/hr

Contractor

Medical, Dental, Vision, Life, Retirement

Posted 24 days ago


Job description

Job Title: Computer Systems Validation Specialist - PLM Implementation Location: Cary, IL or Remote Type: 9 month contract Compensation: $44-48/hour, depending on qualifications Work Model: Remote – offsite Hours: 40.0 Overview: Supports Product Lifecycle Management (PLM) implementation by developing validation documentation, supporting system configuration, executing user acceptance testing, and ensuring compliant system adoption in a regulated environment.

Responsibilities:

  • Develop user requirements, functional requirements, and validation documentation supporting PLM implementation.
  • Support PLM configuration, workflow reviews, data mapping, and system readiness activities.
  • Develop and execute User Acceptance Testing (UAT), manage defects, and validate system functionality.
  • Author CSV deliverables, including URS, FS/DS, risk assessments, RTM, IQ/OQ/PQ protocols, and validation summary reports.
  • Collaborate with IT, Quality, vendors, and project teams to support system implementation, documentation, and validation activities.

Requirements:

  • Bachelor of Science in Computer Science, Engineering, Business, or a related discipline.
  • 3+ years of experience in Computerized System Validation (CSV/CSA) with strong document authoring experience.
  • Experience with GxP/FDA-regulated systems, requirements gathering, functional analysis, and User Acceptance Testing (UAT).
  • Experience supporting QMS, PLM, or document management systems; prior PLM implementation and validation experience preferred.
  • Preferred: Experience with PLM software such as Agile or MasterControl and knowledge of cGMP, cGDP, and 21 CFR Part 11 regulations.

System One, and its subsidiaries including Joulé and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.

#M- #LI-

Ref: #561-Joule Staffing - Parsippany


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About System One

Sourced by ZipRecruiter

System One helps employers get work done more efficiently and economically without compromising quality. Over our 35+ year history, we've helped connect thousands of talented people with innovative companies. The excitement of a perfect fit motivates us every single day.

Industry

Business consulting services and recruiting and staffing services

Company size

5,001 - 10,000 Employees

Headquarters location

Pittsburgh, PA, US