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How much do computer system validation jobs pay per hour?

As of Jul 8, 2026, the average hourly pay for computer system validation 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 some typical challenges faced in Computer System Validation roles?

Professionals in Computer System Validation often encounter challenges such as keeping up with evolving regulatory requirements, ensuring complete and accurate documentation, and coordinating with cross-functional teams to implement validation protocols. Balancing thoroughness with project deadlines can also be demanding, as every validation step must stand up to external audits. However, these challenges provide valuable experience, strengthen project management abilities, and emphasize teamwork—key attributes that support career advancement into validation leadership or quality assurance roles.

What is a Computer System Validation job?

A Computer System Validation (CSV) job involves ensuring that computer systems used in regulated industries, such as pharmaceuticals and medical devices, meet compliance and regulatory requirements. CSV professionals develop and execute validation protocols to confirm that software, hardware, and processes function as intended and maintain data integrity. They work with quality assurance, IT, and regulatory teams to document compliance with standards like FDA 21 CFR Part 11 and GxP. This role is critical in maintaining system reliability, product quality, and patient safety.

What are the key skills and qualifications needed to thrive in the Computer System Validation position, and why are they important?

To excel in Computer System Validation, candidates typically need a background in computer science, engineering, or life sciences, with expertise in validating software and systems in regulated environments such as pharmaceuticals or medical devices. Familiarity with tools like validation documentation software, GAMP 5 guidelines, FDA 21 CFR Part 11 regulations, and potentially certifications like CSV Professional or Six Sigma is highly valued. Strong attention to detail, analytical thinking, and effective communication skills help professionals work collaboratively and document findings precisely. These abilities ensure compliance, data integrity, and the reliability of computerized systems critical to safety and quality.

What is the work of computer system validation?

Computer System Validation (CSV) is the process of ensuring that computer systems used in regulated environments function correctly and comply with industry standards. It involves documenting and testing software, hardware, and related processes to verify they meet specified requirements, often using validation protocols and tools. CSV is essential in industries like pharmaceuticals and healthcare to ensure data integrity and regulatory compliance.

What degree is best for cis jobs?

For Computer System Validation (CSV) roles, a bachelor's degree in computer science, information technology, life sciences, or engineering is typically preferred. Relevant certifications such as GxP or validation-specific training can enhance job prospects, and strong knowledge of regulatory requirements like FDA or EMA guidelines is beneficial.

What is the salary of SoC validation engineer?

The salary of a SoC validation engineer typically ranges from $80,000 to $130,000 annually, depending on experience, location, and company size. Professionals in this role often have skills in hardware description languages and verification tools, which can influence compensation.
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Computer System Validation jobs near you
Infographic showing various Computer System Validation job openings in the United States as of July 2026, with employment types broken down into 1% As Needed, 85% Full Time, 12% Part Time, and 2% Contract. Highlights an 82% Physical, 1% Hybrid, and 17% Remote job distribution, with an average salary of $112,983 per year, or $54.3 per hour.
Computer Systems Validation Specialist

Computer Systems Validation Specialist

kindeva

Saint Louis, MO • On-site

Other

Re-posted 24 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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