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Senior Computer System Validation Csv Jobs in Chicago, IL

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 ...

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 ...

MATRIX DESIGN LLC

Senior Mechanical Engineer

Bartlett, IL

$103K - $136K/yr

Create detailed 3D models and technical drawings using CAD software. * Conduct feasibility studies ... Hands-on experience in prototyping, testing, and system validation. * Clean sheet mechanical design ...

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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

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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 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.

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Senior Computer System Validation Csv jobs near you

Validation Engineer (Computer Systems)

Fresenius Kabi

Melrose Park, IL • On-site

$65K - $80K/yr

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Posted 5 days ago

Fresenius Kabi rating

8.3

Company rating: 8.3 out of 10

Based on 43 frontline employees who took The Breakroom Quiz

25th of 86 rated pharmaceutical

Job description

Job Summary
THIS JOB IS A FULL-TIME ONSITE POSITION, NO CONTRACT WORK AVAILABLE.
THIS JOB IS NOT ELIGIBLE FOR VISA SPONSORSHIP NOW OR IN THE FUTURE.
Salary: $65,000 to $80,000
Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities.
Our benefits and programs are comprehensive and thoughtfully crafted to ensure our colleagues live healthy lives and have support when it matters most. Benefits offered include a 401(k) plan with company contributions, paid vacation, holiday and personal days, employee assistance program, and health benefits to include medical, prescription drug, dental and vision coverage. Read more about our benefits here.
Responsibilities
The Validation Engineer is specialized in computerized systems validation and knowledgeable in MES (EBR) , historian(QMIB), LAB -X and other manufacturing applications. Provides technical & documentation support for manufacturing process and associated computer systems. Also compliance knowledge on various aseptic manufacturing processes (sterilization, isolator technology, clean rooms, computerized systems, etc). Uses his/her expertise to maintain industry standards within the company.
The focus of the Validation Engineer is on technical and documentation aspects of the department and typically does not have direct report. The Validation Engineer must have excellent verbal and written communication skills as this position interacts directly with multiple departments at the site, regional and global levels.
Job Responsibilities:
  • Schedules and executes computer system qualifications per Standard Operating Procedures (SOPs). Coordinates and communicates all testing with affected functional groups and evaluates test results. Assembles and composes the final report and circulates for approval.
  • Executes validation studies (utility, equipment, cleaning, process, computer, and new products) to include protocol preparation, scheduling, protocol execution, and final report preparation. Presents results to Regulatory Agency when necessary.
  • Participates in dry running the manufacturing system applications and develops the test scenarios, test environments, test scripts.
  • Develops and updates full life cycle documents includes, URS, FDS, DS, risk assessments, impact assessment, FMEAs and test and qualification protocols.
  • Develops/improves validation programs as needed to remain current with cGMPs and industry standards
  • Represents Technical Services in teams assembled to specify, install, validate, troubleshoot and maintain systems, equipment and processes.
  • Conducts and/or participates in deviation investigations to identify root causes and define corrective and/or preventative actions (CA/PA).
  • Authors validation master plans and validation project plans outlining qualification requirements
  • Authors the documentation needed for MES(EBR), Historian(QMIB), manufacturing applications and infrastructure like industrial data center, etc.
  • Provides technical support for Investigations, Action Plans, Change Controls and Risk Assessments as required. Generates innovative solutions to solve difficult problems that may impact multiple disciplines
  • Additional projects and tasks as assigned.
  • All employees are responsible for ensuring the compliance to company documents, programs and activities related to the Health, Safety, Environment, Energy, and Quality Management Systems, as per your roles and responsibilities

Job Requirements:
  • Bachelor's Degree in a Science or Engineering field of study
  • Minimum of one year of related experience in a cGMP facility, including experience with FDA regulations, medical, drug and device products.
  • Installation, Operational and Performance Qualification protocol generation and execution experience
  • Knowledge and understanding of cGMPs, industry guidance, and aseptic techniques
  • Excellent technical writing and verbal communication skills. Experienced in negotiating.
  • Understanding of MES(EBR), historian, oee, and other manufacturing applications.
  • PC literate with standard office application (Word, Excel, PowerPoint, Project, Access) competency
  • Good communication skills and leadership skills.
  • Good judgment and decision skills.
  • Problem solving and multi-tasking.
  • Project supervision and project management skills.
  • Ability to work independently.
  • Ability to adapt and handle change.
  • Knowledge of cGMP Process and Product Validation requirements and techniques.

The Company's primary business language is English. The successful candidate must be able to effectively speak, read, write, and understand English to perform the essential functions of the position, including independently understanding policies, procedures, training materials, and workplace communications written in English due to our heavily regulated work environment.
Additional Information
We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company contribution, and wellness program.
Please note that joining our team does not create a guaranteed or permanent employment arrangement. All employment is at-will, meaning both the employee and Fresenius Kabi have the right to end the employment relationship at any time, in accordance with applicable federal and state laws.
Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.

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