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How much do computer system validation specialist jobs pay per hour?

As of Jun 29, 2026, the average hourly pay for computer system validation specialist in the United States is $54.32, according to ZipRecruiter salary data. Most workers in this role earn between $41.83 and $64.42 per hour, depending on experience, location, and employer.

What are the key skills and qualifications needed to thrive as a Computer System Validation Specialist, and why are they important?

To thrive as a Computer System Validation Specialist, you need expertise in computer science, regulatory compliance (such as FDA 21 CFR Part 11 and GxP), and a background in life sciences or IT, often supported by a relevant bachelor's degree. Familiarity with validation lifecycle documentation, risk management tools, and computerized system validation (CSV) software is essential. Strong analytical thinking, attention to detail, and effective communication skills help ensure thorough documentation and collaboration across departments. These abilities are crucial to maintain regulatory compliance, data integrity, and smooth system implementation in highly regulated industries.

What are some common challenges faced by Computer System Validation Specialists during project implementation?

Computer System Validation Specialists often encounter challenges such as managing tight project timelines, ensuring compliance with evolving regulatory standards, and coordinating with cross-functional teams like IT, QA, and business users. Navigating diverse documentation requirements and handling unexpected changes to system specifications can also be demanding. Effective communication, attention to detail, and proactive risk management are essential to successfully overcome these obstacles and deliver compliant, validated systems.

What Does a Computer System Validation Specialist Do?

A computer system validation specialist coordinates validation efforts for computer systems, hardware, and software, especially within a manufacturing setting, to ensure product quality. As a CSV specialist, your responsibilities include managing computer validation project activities and creating computer system planning documents and testing protocols. You also review test results and identify areas of improvement to implement changes. Other duties include providing technical expertise to customers and the validations department while communicating the validation plan and creating protocols. You may also ensure that each product is compliant with Current Good Manufacturing Practice (CGMP), Good Automated Manufacturing Practice (GAMP), and Code of Federal Regulations.

What does a Computer System Validation Specialist do?

A Computer System Validation Specialist ensures that computer systems used in regulated industries, such as pharmaceuticals or medical devices, comply with regulatory requirements and function as intended. They develop and execute validation protocols, document processes, and work closely with quality assurance and IT teams to maintain compliance. Their work helps guarantee data integrity, product quality, and patient safety by ensuring systems are reliable and audit-ready.

What is the difference between Computer System Validation Specialist vs Quality Assurance Specialist?

AspectComputer System Validation SpecialistQuality Assurance Specialist
CertificationsGxP, 21 CFR Part 11, CSV-specific trainingISO 9001, Six Sigma, QA certifications
Work EnvironmentPharmaceutical, biotech, regulated industriesManufacturing, software, healthcare sectors
Employer & Industry UsageRegulated industries requiring compliance documentationBroadly used across industries for process quality

The Computer System Validation Specialist focuses on ensuring computer systems meet regulatory standards through validation processes, primarily in regulated industries like pharma and biotech. In contrast, the Quality Assurance Specialist oversees overall quality processes, including audits and compliance, across various sectors. While both roles emphasize compliance and documentation, the CSV Specialist is more technical and specific to computer systems validation, whereas the QA Specialist has a broader scope in quality management.

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Computer System Validation Specialist jobs near you
Infographic showing various Computer System Validation Specialist job openings in the United States as of June 2026, with employment types broken down into 2% As Needed, 65% Full Time, 31% Part Time, 1% Temporary, and 1% Contract. Highlights an 93% Physical, 2% Hybrid, and 5% Remote job distribution, with an average salary of $112,983 per year, or $54.3 per hour.

Computer Systems Validation Specialist

kindeva

Saint Louis, MO

Other

Posted 14 days ago

Kindeva rating

6.8

Company rating: 6.8 out of 10

Based on 6 frontline employees who took The Breakroom Quiz

Job description

Our Work Matters

At Kindeva we make products that save lives, ensuring better health and well-being for patients around the world.

The Impact You Will Make

The Computer System Validation (CSV) Specialist is responsible for ensuring that all GxP computer systems used in pharmaceutical manufacturing environments are validated, maintained, and compliant with applicable regulatory requirements including FDA 21 CFR Part 11, EU Annex 11, and GAMP 5 guidelines.

This role supports the full lifecycle of computerized systems including implementation, qualification, maintenance, periodic review, and retirement, ensuring data integrity, system reliability, and inspection readiness across multiple sites or facilities.

Responsibilities

  • Validation Lifecycle Execution
    • Lead and/or support validation activities for GxP computerized systems including MES, SCADA/PLC, LIMS, EM systems, and serialization/packaging systems
    • Author and execute validation documentation: URS, FS/DS, Risk Assessments, IQ/OQ/PQ, Traceability Matrices, Periodic Reviews / Audit Trail Reviews
    • Ensure validation deliverables meet internal SOPs and regulatory expectation
  • Regulatory Compliance & Data Integrity
    • Ensure compliance with 21 CFR Part 11, EU Annex 11, and ALCOA+ principles
    • Perform periodic reviews of validated systems
    • Support FDA, EMA, and internal audits/inspections
    • Assess and remediate data integrity risks
  • Change Control & Lifecycle Management
    • Support system changes through formal change control processes
    • Evaluate impact of updates, patches, and configuration changes
    • Ensure appropriate re-validation activities
    • Maintain systems in a validated state
  • Risk-Based Validation Strategy
    • Apply GAMP 5 risk-based validation approach
    • Classify systems based on complexity and GxP impact
    • Lead risk assessments (FMEA, system risk ranking)
  • Cross-Functional Collaboration
    • Partner with IT, QA, Manufacturing, MS&T, and Engineering
    • Provide CSV guidance during system implementation and facility startup
    • Support digital transformation initiatives
  • Documentation & Inspection Readiness
    • Maintain GMP-compliant validation documentation
    • Ensure audit readiness and traceability
    • Support responses to audit findings and regulatory observations
  • Continuous Improvement
    • Improve validation processes and templates
    • Support implementation of electronic validation systems (e.g., Kneat, Veeva)
    • Drive standardization across sites

Qualifications

  • Bachelor’s degree in Engineering, Computer Science, Information Systems, Life Sciences, or related field
  • Minimum of 5 years in Computer System Validation in GMP-regulated pharmaceutical or biotech environments
  • Experience with manufacturing and laboratory systems validation
  • Hands-on experience with Part 11 / Annex 11 compliance
  • Strong knowledge of GAMP 5, 21 CFR Part 11, EU Annex 11, and ALCOA+
  • Familiarity with MES, ERP, LIMS, SCADA/PLC systems
  • Understanding of system architecture, interfaces, backup, disaster recovery, and cybersecurity
  • Experience in aseptic/sterile injectable manufacturing preferred
  • Multi-site validation program experience preferred
  • Familiarity with serialization, AVI systems, and cold storage monitoring preferred
  • Experience with Kneat, ValGenesis, or Veeva is desirable
  • Experience with facility startup and commissioning

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