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Computer System Validation Engineer Jobs (NOW HIRING)

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 ...

The Validation Engineer will be responsible for the following. * Develop, approve, and execute ... Experience with SCADA, MES, and database systems, or computer system validation are considered a ...

We are looking for a SerDes System Validation Engineer to lead system validation of mixed-signal SerDes IP. In this highly visible role, you will actively work within Analog-Mixed/Signal design team ...

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Computer System Validation Engineer information

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

As of Jul 24, 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.
More about Computer System Validation Engineer jobs
What cities are hiring for Computer System Validation Engineer jobs? Cities with the most Computer System Validation Engineer job openings:
What states have the most Computer System Validation Engineer jobs? States with the most job openings for Computer System Validation Engineer jobs include:
Infographic showing various Computer System Validation Engineer 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 $107,747 per year, or $51.8 per hour.
Automation Validation Engineer - Biotechnology Systems

Automation Validation Engineer - Biotechnology Systems

Intellectt INC

Hopewell, NJ • On-site

Contractor

Posted 29 days ago


Job description

Hello,

I hope you're doing well.
My name is Mahalakshmi, and I’m reaching out from Intellectt Inc. regarding an exciting contract opportunity for a Automation Validation Engineer - Biotechnology Systems based in Hopewell, NJ with one of our prestigious clients.

I would love to connect and discuss this opportunity in more detail. Please feel free to share your updated resume at mahalakshmi.n@intellectt.com  OR +1 (732) 737 8381
Role: Automation Validation Engineer - Biotechnology Systems
Location: Hopewell, NJ

Job Description:

We are hiring an experienced Automation Validation Engineer to contribute to the successful launch of our new manufacturing facility. This role offers the opportunity to work on innovative biopharmaceutical processes, making a meaningful impact in a fast-growing industry.

Responsibilities:

  • Support IO Check, system integration, and validation for startup activities.
  • Provide technical assistance to OEM engineers and facilitate system integration.
  • Participate in SAT/IQ/OQ phases, ensuring smooth validation processes.
  • Execute test protocols, manage change controls, and address exceptions.
  • Handle system backups, user group setup, and develop training documentation.

Qualifications:

  • Bachelor’s degree in Electrical, Chemical Engineering, or a related field.
  • Experience working in FDA-regulated biotech, pharmaceutical, or medical device environments.
  • Expertise in automation, electrical control systems, and computer system validation (CSV).
  • Familiarity with upstream and downstream biopharmaceutical processes.
  • Proficiency in tools such as Studio 5000 Logix Designer, FTView SE & ME.
    Thanks & Regards,
    Mahalakshmi
    Junior Recruiter
    Intellectt Inc 
    mahalakshmi.n@intellectt.com
    Direct: +1 (732) 737 8381