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Senior Computer System Validation Csv Jobs in Bolingbrook, 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 ...

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

See Bolingbrook, 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 Bolingbrook, IL is $64.05, according to ZipRecruiter salary data. Most workers in this role earn between $51.11 and $72.74 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 Bolingbrook, IL?

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

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

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

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

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

Computer System Validation (CSV) Engineer

Clappr LLC

Chicago, IL • On-site

$60 - $65/hr

Other

This job post has expired 3 days ago. Applications are no longer accepted.


Job description

We're looking for an experienced CSV Engineer to support validation activities across a wide portfolio of regulated systems — from laboratory instrumentation to manufacturing equipment to enterprise platforms. This role acts as the connective tissue between Quality, IT, Lab, and Manufacturing, keeping systems validated and maintained in compliance with 21 CFR Part 11, GxP, and EMA requirements. This is an onsite role reporting to the Sr. Director of IT, and candidates must be authorized to work in the U.S. without current or future sponsorship.


Contract to Hire: $60-$65/hour


What you'll do


  • Plan, author, and execute validation deliverables — including Validation Plans, URS, FS, DS, IQ/OQ/PQ protocols, Traceability Matrices, and Validation Summary Reports — across assigned systems


  • Support CSV activities spanning lab instruments (HPLC, GC, spectrophotometers, balances, and similar), engineering and manufacturing equipment, and enterprise systems such as Caliber LIMS, SAP, and BMRAM


  • Partner with system owners, QA, and IT to keep systems in a validated state through change control and periodic review


  • Execute risk assessments and data integrity assessments aligned with ALCOA+ principles


  • Support audits, inspections, CAPA investigations, and deviations involving computerized systems


  • Collaborate with senior validation leads and subject matter experts to drive consistent validation practices across sites

  • What you'll bring


    • Bachelor's degree in Life Sciences, Engineering, or IT — or equivalent laboratory experience in a life sciences environment


    • Minimum 5 years of CSV experience in a GxP-regulated environment


    • Working knowledge of 21 CFR Part 11, EU Annex 11, and EMA guidance


    • Hands-on experience authoring and executing IQ/OQ/PQ protocols

    • Validation experience with at least two of: laboratory instruments, engineering/manufacturing equipment, LIMS, SAP, or CMMS/calibration platforms (e.g., BMRAM)


    Nice to have


    • Familiarity with GAMP 5 principles and risk-based validation approaches


    • Exposure to Caliber LIMS


    • Exposure to SAP (QM, MM, PP) in a GxP context


    • Experience with BMRAM or an equivalent CMMS/calibration system


    • Prior experience serving as a liaison across IT, Quality, Lab, and Manufacturing teams

  • Benefits & perks

    This is an onsite position in a fast-paced, deadline-driven setting. It may require extended hours or occasional weekend work, and moderate domestic travel. Physical requirements are light