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Computer System Validation Engineer Jobs (NOW HIRING)

Intellectt INC

Senior Validation Engineer

Portland, OR · On-site

Seeking a Senior Validation Engineer with strong GMP experience to support QC equipment validation and Computer System Validation (CSV) activities. Key Responsibilities: * Author & execute URS, IQ/OQ ...

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

As of Jul 1, 2026, the average hourly pay for computer system validation engineer 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 are some common challenges faced by Computer System Validation Engineers in regulated industries?

Computer System Validation Engineers often encounter challenges such as keeping up with evolving regulatory requirements, managing documentation for multiple systems, and ensuring timely validation while coordinating with cross-functional teams. Balancing strict compliance with project deadlines can be demanding, especially when systems are complex or legacy infrastructure is involved. Additionally, effective communication with IT, QA, and business stakeholders is essential to address issues quickly and maintain validation standards.

What does a computer system validation engineer do?

A computer system validation engineer ensures that computer systems used in regulated industries meet required standards for quality, safety, and compliance. They develop validation protocols, perform testing, document results, and ensure systems function correctly according to regulatory guidelines such as FDA or GMP. This role often involves working with validation tools, risk assessments, and maintaining detailed documentation to support audits and inspections.

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

To thrive as a Computer System Validation Engineer, you need a solid background in computer science or engineering, knowledge of regulatory requirements (such as FDA or GxP), and experience in validation processes. Familiarity with validation tools, quality management systems, and documentation software is typically required, along with certifications like ISPE or ASQ being beneficial. Strong attention to detail, analytical thinking, and effective communication are essential soft skills for coordinating teams and ensuring compliance. These skills and qualities are crucial to ensure that computer systems meet regulatory standards, maintain data integrity, and support business operations in regulated industries.

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

AspectComputer System Validation EngineerQuality Assurance Specialist
CertificationsGAMP, GxP validation certificationsISO, Six Sigma, GMP certifications
Work EnvironmentPharmaceutical, biotech, medical device industriesManufacturing, software, healthcare sectors
Primary FocusValidating computer systems and software complianceEnsuring overall quality and process improvements

The Computer System Validation Engineer primarily focuses on validating computer systems to meet regulatory standards, ensuring software compliance in regulated industries. In contrast, the Quality Assurance Specialist oversees broader quality processes, including audits and process improvements. Both roles require knowledge of industry regulations but differ in scope and specific responsibilities.

What is the salary of SoC validation engineer?

The salary of a System on Chip (SoC) validation engineer typically ranges from $80,000 to $130,000 annually, depending on experience, location, and company size. Entry-level positions may start lower, while experienced engineers with specialized skills in hardware description languages and verification tools can earn higher salaries.

What is the salary of a CSV engineer?

The salary of a Computer System Validation (CSV) Engineer typically ranges from $70,000 to $120,000 annually, depending on experience, location, and certifications such as GxP or 21 CFR Part 11. Senior roles or those in high-cost-of-living areas may offer higher compensation, and knowledge of validation tools like MasterControl or ValGenesis can enhance earning potential.

Is computer system validation a good field?

Computer System Validation (CSV) is a vital field in regulated industries like pharmaceuticals and biotech, ensuring software and systems meet compliance standards such as 21 CFR Part 11. It offers stable job opportunities, requires knowledge of validation protocols, and often involves working with tools like GxP guidelines and validation documentation. The field is considered stable and growing due to ongoing regulatory requirements.
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Computer System Validation Engineer jobs near you
Infographic showing various Computer System Validation Engineer job openings in the United States as of June 2026, with employment types broken down into 93% Full Time, and 7% Contract. Highlights an 93% Physical, 2% Hybrid, and 5% Remote job distribution, with an average salary of $107,747 per year, or $51.8 per hour.

Computer System Validation Engineer

Stark Pharma Solutions Inc

Indianapolis, IN • On-site

Contractor

Posted 3 days ago

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Job description

Job Title: Validation Engineer

Location: Indianapolis / Bloomington, IN (100% Onsite)

Duration: Long term Contract

Interview Mode: Onsite (Local candidates preferred)

Job Summary:

We are seeking a Validation Engineer with strong experience in Computer Systems Validation (CSV), equipment qualification, and GMP-regulated environments. The ideal candidate will support validation activities, documentation migration, and equipment qualification to ensure compliance with regulatory standards.

Key Responsibilities

  • Lead migration of legacy validation documents into the Kneat digital platform, ensuring accuracy and compliance
  • Perform equipment qualification for lab instruments (pH meters, thermal mixers, peristaltic pumps, nutating mixers, etc.)
  • Execute temperature mapping studies, including work with Ellab systems or similar equipment
  • Support Computer Systems Validation (CSV) activities and documentation
  • Assist Process Engineering teams to ensure project timelines and milestones are met
  • Ensure all validation activities comply with GMP and regulatory requirements
  • Maintain clear, accurate, and compliant documentation

Required Qualifications:

  • Bachelor’s degree in Engineering, Science, or related field
  • 6+ years of experience in Computer Systems Validation (CSV)
  • 4+ years of experience in pharmaceutical manufacturing environment
  • Hands-on experience with equipment qualification and validation
  • Strong knowledge of CSV principles and regulatory compliance
  • Experience working in onsite, fast-paced environments