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Senior Computer System Validation Csv Jobs in Chicago, IL

Compsciprep LLC

CSV Validation Consultant

Chicago, IL · On-site

Computer System Validation (CSV) / Validation Consultant - Life Sciences Location: Multiple Location Summary: We are looking for an experienced Computer System Validation (CSV) Consultant with strong ...

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 ...

AbbVie

Engineer, Validation Commissioning

North Chicago, IL · On-site

$65K/yr

  • Medical

  • Dental

  • Vision

  • Retirement

  • PTO

Experience with Computer System Validation (CSV) is required. * 2+ years of overall experience in Manufacturing, Quality or Engineering including 2 major validation subjects (e.g. Computer, Equipment ...

AbbVie

Engineer, Validation Commissioning

North Chicago, IL · On-site

  • Medical

  • Dental

  • Vision

  • Retirement

  • PTO

Experience with Computer System Validation (CSV) is required. * 2+ years of overall experience in Manufacturing, Quality or Engineering including 2 major validation subjects (e.g. Computer, Equipment ...

AbbVie

Engineer, Validation Commissioning

North Chicago, IL

  • Medical

  • Dental

  • Vision

  • Retirement

  • PTO

Experience with Computer System Validation (CSV) is required. * 2+ years of overall experience in Manufacturing, Quality or Engineering including 2 major validation subjects (e.g. Computer, Equipment ...

AbbVie

Engineer, Validation Commissioning

North Chicago, IL

  • Medical

  • Dental

  • Vision

  • Retirement

  • PTO

Experience with Computer System Validation (CSV) is required. * 2+ years of overall experience in Manufacturing, Quality or Engineering including 2 major validation subjects (e.g. Computer, Equipment ...

AbbVie

Engineer, Validation Commissioning

North Chicago, IL

  • Medical

  • Dental

  • Vision

  • Retirement

  • PTO

Experience with Computer System Validation (CSV) is required. * 2+ years of overall experience in Manufacturing, Quality or Engineering including 2 major validation subjects (e.g. Computer, Equipment ...

AbbVie

Engineer, Validation Commissioning

North Chicago, IL · On-site

$65K/yr

  • Medical

  • Dental

  • Vision

  • Retirement

  • PTO

Experience with Computer System Validation (CSV) is required. * 2+ years of overall experience in Manufacturing, Quality or Engineering including 2 major validation subjects (e.g. Computer, Equipment ...

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 Chicago, IL

Senior Computer System Validation Csv information

See Chicago, IL salary details

$35

$66

$101

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

As of Aug 16, 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 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 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 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.

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Senior Computer System Validation Csv jobs near you

Senior CSV Engineer

Katalyst Healthcares and Lifesciences

Chicago, IL • On-site

$107K - $147K/yr

Other

Posted 2 days ago

New

Job description

Job Description:
The Senior Computer System Validation (CSV) Engineer is responsible for leading validation activities for computerized systems used in regulated environments such as pharmaceutical, biotechnology, or medical device manufacturing. This role ensures that systems including LIMS, ERP, MES, and laboratory applications are validated in compliance with FDA, EU, and global regulatory requirements. The Senior CSV Engineer will act as a subject matter expert (SME), providing guidance on validation strategy, risk-based approaches, and regulatory compliance across the system lifecycle.
Responsibilities:
  • Lead and execute computer system validation (CSV) activities for GxP-regulated systems.
  • Develop and review validation deliverables including validation plans, URS, FS, DS, risk assessments, IQ/OQ/PQ protocols, and summary reports.
  • Ensure compliance with FDA 21 CFR Part 11, EU Annex 11, GAMP 5, and GxP regulations.
  • Define and implement risk-based validation strategies for computerized systems.
  • Oversee validation of systems such as LIMS, ELN, MES, ERP, CDS, and laboratory systems.
  • Support system implementations, upgrades, and decommissioning activities from a validation perspective.
  • Collaborate with IT, QA, Engineering, and business stakeholders to ensure compliant system deployment.
  • Lead change control assessments and determine validation impact of system changes.
  • Ensure data integrity (ALCOA+) compliance across validated systems.
  • Support audits and regulatory inspections by providing validation documentation and system justification.
  • Mentor and guide junior CSV engineers and validation team members.
  • Drive continuous improvement of validation processes, templates, and standards.
  • Review vendor documentation and ensure systems meet regulatory expectations prior to deployment.
Requirements:
  • Bachelor's degree in Engineering, Computer Science, Life Sciences, or related field.
  • 5-10+ years of experience in Computer System Validation (CSV) or validation engineering.
  • Strong experience in GxP-regulated pharmaceutical, biotech, or medical device environments.
  • Hands-on experience with validation of LIMS, MES, ERP, or laboratory systems.
  • Strong knowledge of 21 CFR Part 11, EU Annex 11, and GAMP 5 guidelines.
  • Experience authoring and executing IQ/OQ/PQ protocols and validation documentation.
  • Strong understanding of risk-based validation and data integrity principles.
  • Experience supporting regulatory audits and inspections.
Preferred Skills:
  • Experience with systems such as LabWare, SAP, Oracle, Veeva, TrackWise, Empower.
  • Knowledge of cloud-based validation and SaaS systems.
  • Experience in data integrity remediation projects.
  • Strong technical writing and documentation skills.
  • bility to lead cross-functional validation projects.
Key Competencies:
  • Strong leadership and SME-level expertise in CSV.
  • Excellent analytical and risk assessment skills.
  • Strong communication and stakeholder management.
  • bility to manage multiple validation projects simultaneously.
  • High attention to detail and regulatory compliance mindset.

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