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Senior Computer System Validation Csv Jobs in Elgin, IL

OnShore Technology Group

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 ...

New

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 ...

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 ...

WilsonCTS

Engineer, Quality Assurance

Cary, IL · On-site

$52 - $54/hr

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 ...

Deloitte

System Test and Validation Lead

Chicago, IL · On-site +1

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 ...

Deloitte

System Test and Validation Lead

Chicago, IL · On-site +1

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 ...

Deloitte

System Test and Validation Lead

Chicago, IL · On-site +1

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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All JobsComputer System Validation Csv JobsSenior Computer System Validation Csv JobsSenior Computer System Validation Csv Jobs in Elgin, IL

Senior Computer System Validation Csv information

See Elgin, IL salary details

$34

$64

$97

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

As of Sep 4, 2026, the average hourly pay for senior computer system validation csv in Elgin, IL is $64.03, according to ZipRecruiter salary data. Most workers in this role earn between $51.11 and $72.69 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 Elgin, IL?

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Senior Computer System Validation Csv jobs near you

Sr. Validation Lead

OnShore Technology Group

Chicago, IL • On-site

$120 - $170/hr

Other

Posted 3 days ago

New

Job description

For over 15 years, we have worked as a trusted partner with our clients as well as many global system integrators and technology companies to help deliver turnkey validated systems and ensure sustained compliance.

OnShore’s leading innovation is ValidationMaster™, the first Enterprise Validation Management System (EVMS) of its kind to include a validation Kanban board and seamless integration with our unique ValidationMaster Quality and Risk Management portal.

The Sr. Validation Lead is primarily responsible for oversight of V&V activities for designated computerized system implementation projects. 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 adherence to internal procedures, industry practices such as ISPE GAMP 5, and applicable regulations such as FDA 21 CFR Part 11, EudraLex Annex 11, SOX and cGMPs.

ROLES & RESPONSIBILITIES
  • Ability to lead and coordinate multiple CSV projects
  • Develop / review validation test protocols as required using automated technology tools
  • Coordinate / communicate with other departments, SMEs
  • Ensure that all validation deliverables are prepared in accordance with internal guidelines, policies and procedures
  • Create, track and manage all validation project plans
  • Provide regulatory guidance on principles of CSV to the expanded team
EDUCATION & CERTIFICATION
  • B.S. or equivalent in computer science, engineering, life sciences, or related field
  • Minimum 10 years of experience in software quality assurance in the life sciences industry in a leadership role
  • ASQ CSQE Certification or equivalent preferred
  • Practical working knowledge of software development and implementation methodologies
  • Experience with the validation of Enterprise Resource Planning (ERP) systems is preferred.
  • Strong oral and written communication skills in English.
  • Excellent interpersonal skills.
  • Advanced skills at team management, organization, and communication of priorities and listening
  • Practical experience in conducting and supporting CSV audits and inspections.
  • Advanced proficiency in the use of Microsoft Office desktop applications
REGULATORY KNOWLEDGE REQUIREMENTS
  • U.S. FDA Validation Guidance Document
  • 21 CFR Part 11 Electronic Records; Electronic Signature Final Rule
  • U.S. FDA Data Integrity Guidance
  • NIST Cybersecurity Framework
  • 21 CFR Part 210/211 cGMP
  • EUDRALEX Annex 11 Rules Governing Medicinal Products in the EU, Volume 4
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