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

As of Sep 10, 2026, the average hourly pay for computer system validation director in the United States is $51.80, according to ZipRecruiter salary data. Most workers in this role earn between $38.94 and $64.42 per hour, depending on experience, location, and employer.

What is a computer system validation director?

Computer System Validation Directors oversee and manage the validation of computer systems within regulated industries, such as pharmaceuticals, biotechnology, or medical devices. Their primary responsibility is to ensure that all computer systems used for business and regulatory purposes comply with industry standards and regulatory requirements, such as FDA or EMA guidelines. They often lead validation teams, develop validation strategies and protocols, and work closely with IT, quality assurance, and compliance departments. This role is crucial to ensure data integrity, patient safety, and regulatory compliance throughout the system lifecycle.

What are the key skills and qualifications needed to thrive as a computer system validation director?

To thrive as a Computer System Validation Director, you need expertise in computer system validation (CSV), regulatory compliance (such as FDA 21 CFR Part 11), and a relevant degree in life sciences, engineering, or IT. Familiarity with validation lifecycle management tools, quality management systems (QMS), and knowledge of industry standards like GAMP 5 are typically required. Strong leadership, project management, and communication skills are essential for leading cross-functional teams and ensuring clarity in compliance objectives. These skills are crucial to ensure validated systems meet regulatory requirements, minimize risk, and support organizational quality goals.

What are the main challenges a computer system validation director might face when leading validation projects across multiple global sites?

A Computer System Validation Director often encounters challenges such as navigating differing regulatory requirements across countries, coordinating cross-functional teams in various time zones, and ensuring consistent validation standards are maintained globally. Balancing project timelines with compliance demands can be difficult, especially when local teams have varying levels of validation experience. Strong communication, project management skills, and a deep understanding of international regulations are essential for overcoming these obstacles and ensuring successful, compliant system implementations.

What is the difference between Computer System Validation Director vs Validation Manager?

AspectComputer System Validation DirectorValidation Manager
CredentialsTypically requires a Bachelor's or Master’s in Life Sciences, Engineering, or related fields; certifications like GxP, CSV certificationsSimilar credentials, often with additional certifications in validation or quality assurance
Work EnvironmentLeads validation teams in pharmaceutical, biotech, or medical device companies; strategic roleManages validation activities, oversees teams, and ensures compliance at operational levels
Industry UsageUsed across regulated industries for high-level validation oversightCommonly used in the same industries for day-to-day validation management

The main difference is that the Computer System Validation Director holds a strategic, leadership role overseeing validation programs, while the Validation Manager handles daily validation activities and team management. Both roles require similar credentials and are vital in regulated industries like pharma and biotech.

What cities are hiring for Computer System Validation Director jobs?

Cities with the most Computer System Validation Director job openings:

What are the most commonly searched types of Computer System Validation jobs?

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Infographic showing various Computer System Validation Director job openings in the United States as of September 2026, with employment types broken down into 1% As Needed, 85% Full Time, 12% Part Time, and 2% Contract. Highlights an 91% Physical, 2% Hybrid, and 7% Remote job distribution, with an average salary of $107,747 per year, or $51.8 per hour.

Senior Computer Systems Validation Engineer

San Carlos, CA • Hybrid

Vaxcyte
Biotechnology Research and Development • 51 - 200 employees
Learn more about Vaxcyteexternal

$164K - $190K/yr

Full-time

Re-posted 17 days ago

Key responsibilities

  • Lead validation activities for cloud-based GxP systems, including databases and applications, throughout their lifecycle.

  • Author, update, execute, and maintain validation deliverables such as validation plans, user requirements, functional specifications, risk assessments, traceability matrices, IQ, OQ, PQ protocols, and summary reports.

  • Assess and validate end-to-end data flows between upstream source systems and downstream applications to ensure accuracy, completeness, and traceability.

Job description

Summary:

The Senior Computer Systems Validation (CSV) Engineer is responsible for leading validation activities for cloud based GxP systems to ensure they meet regulatory, quality, and operational requirements throughout the system lifecycle. The role focuses on traditional Computer System Validation with application of risk-based Computer Software Assurance (CSA) principles where appropriate.

The individual will work closely with IT and Quality teams to validate and maintain GxP systems across their lifecycle. Strong experience validating relational databases, cloud infrastructure, and integrated applications in regulated biotech or pharmaceutical environments is required.

This is a hands-on role requiring authoring and executing validation documents and protocols for GAMP 5 systems.

This is a hybrid role with minimum of 3 days a week onsite at San Carlos, CA location.

Essential Functions:
  • Hands-on lead full lifecycle Computer System Validation activities for cloud based GxP systems including databases, and applications.
  • Author, update, execute and maintain validation deliverables such as Validation Plans, User Requirements, Functional Specifications, Risk Assessments, Traceability Matrices, IQ, OQ, PQ protocols, and Summary Reports.
  • Perform risk assessments to define validation scope, testing strategy, and documentation requirements in alignment with CSA principles.
  • Define and execute validation strategies for data platforms and system components, ensuring systems meet defined functional, security, and data integrity requirements
  • Assess and validate end to end data flows between upstream source systems and downstream applications to ensure accuracy, completeness, and traceability.
  • Evaluate system changes for validation impact and ensure validated systems remain compliant through appropriate testing and documentation.
  • Ensure validation activities align with automated build and deployment pipelines, confirming that system releases maintain validated state and appropriate validation evidence is generated.
  • Support change control, deviation management, periodic review, and lifecycle management of validated systems.
  • Participate in internal audits and regulatory inspections, providing validation documentation and rationale as required.
  • Contribute to continuous improvement of validation procedures aligned with evolving CSA guidance and cloud delivery models.
Requirements: 
  • Bachelor's degree in Computer Science, Engineering, Life Sciences, or related field, or equivalent professional experience.
  • Minimum 7 years of experience in Computer System Validation within biotech manufacturing and lab data systems. Other combinations of education and/or experience may be considered.
  • Must have technical knowledge of IT infrastructure, software engineering, programming, databases and data integrations.
  • Experience working in modern system environments utilizing CI/CD pipelines or automated release processes.
  • Strong hands-on experience validating GAMP 5 systems for biotech manufacturing.
  • Deep understanding of FDA 21 CFR Part 11, Part 210, Part 211, Annex 11, data integrity requirements, and risk-based validation methodologies.
  • Strong technical writing skills and ability to create comprehensive validation documentation.
  • Ability to communicate validation risks and requirements clearly to IT and Quality stakeholders.

Other combinations of education and/or experience may be considered.

Preferred Qualifications:

  • Hands-on experience validating cloud based GxP systems, specifically Azure.
  • Familiarity with infrastructure as code frameworks like GitHub, Terraform etc.
  • Experience applying CSA principles to custom data applications in GxP cloud.
  • Microsoft Azure or similar technical certifications.
Reports to: Senior Manager, Data Systems
 
Location: San Carlos, CA
 
Work Arrangement (may be adjusted based on business needs, job responsibilities, or changes to company policy): 
Hybrid (minimum of 3 days per week onsite)
 
Compensation:
The compensation package will be competitive and includes comprehensive benefits and an equity component.
 
Salary Range: $164,000 - $190,000 (SF Bay Area). Salary ranges for non-California locations may vary.
 
Relocation: 
This role is not eligible for relocation assistance. 
 
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About Vaxcyte

Sourced by ZipRecruiter

Industry

Biotechnology research and development

Company size

51 - 200 Employees

Headquarters location

San Carlos, CA, US

Year founded

2013

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