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Computer System Validation Engineer Jobs (NOW HIRING)

Hired by Matrix

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Computer System Validation (CSV) Engineer

Myerstown, PA · On-site

$65/hr

If so, our client is hiring a Computer System Validation (CSV) Engineer. Position Type: * Contract * Onsite Required: * Bachelor's in Life Sciences, Engineering, or Computer Science * 7 years of CSV ...

Lyte

System Validation Engineer

Sunnyvale, CA · On-site

$130K - $230K/yr

... Engineering from a top research university * ~5 years of hands-on lab experience in PCB bringup, system validation, signal/power integrity, or failure analysis * Solid analog circuit knowledge - bias ...

Apple

SerDes System Validation Engineer

Cupertino, CA · On-site

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 ...

Apple

SerDes System Validation Engineer

Cupertino, CA

$184K - $324K/yr

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 ...

JSat Automation

Validation Engineer

Glendale, CA · On-site

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 ...

Apple

SerDes System Validation Engineer

Cupertino, CA

$129K - $225K/yr

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 Aug 15, 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.

Are computer system validation engineers in demand?

Computer System Validation Engineers are in demand due to the increasing regulation of pharmaceutical, biotech, and medical device industries that require compliant validation of computer systems. They often need skills in validation protocols, GxP regulations, and validation tools, making their expertise valuable in ensuring quality and compliance in regulated environments.

What does a computer system validation engineer do?

A computer system validation engineer ensures that computer systems used in regulated industries, such as pharmaceuticals or biotech, meet required standards for quality and compliance. They develop validation protocols, execute testing, and document results to verify systems function correctly and consistently. This role often involves working with validation tools, regulatory guidelines, and maintaining detailed records to support audits and inspections.

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

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.

Do computer system validation engineers make good money?

Computer System Validation Engineers typically earn competitive salaries that vary by experience, location, and industry. They often have specialized skills in validation protocols, regulatory compliance, and validation tools, which can contribute to higher earning potential. Overall, this role is considered well-compensated within the pharmaceutical, biotech, and healthcare sectors.

Is computer system validation a good field?

Computer System Validation (CSV) is a vital part of regulated industries like pharmaceuticals and biotech, ensuring that computer systems meet quality and compliance standards. It offers opportunities for roles such as validation engineers, often requiring knowledge of GxP regulations, validation protocols, and tools like audit trails. The field provides stable employment with potential for career growth, especially with certifications like GAMP or 21 CFR Part 11 knowledge.
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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 August 2026, with employment types broken down into 1% As Needed, 84% Full Time, 12% Part Time, and 3% Contract. Highlights an 92% Physical, 2% Hybrid, and 6% Remote job distribution, with an average salary of $107,747 per year, or $51.8 per hour.

Computer System Validation (CSV) Engineer

Hired by Matrix

Myerstown, PA • On-site

$65/hr

Contractor

Medical, Dental

Posted 4 days ago

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Job description

At-a-Glance:
Are you ready to build your career by joining a certified technology solutions and compliance consulting services company? If so, our client is hiring a Computer System Validation (CSV) Engineer.

Position Type:

  • Contract
  • Onsite

Required:

  • Bachelor's in Life Sciences, Engineering, or Computer Science
  • 7 years of CSV experience in a regulated pharma or life sciences environment
  • Hands-on validation experience with LIMS, ERP, or MES systems
  • Strong knowledge of GAMP 5, 21 CFR Part 11, and EU Annex 11
  • Ability to author complete, inspection-ready validation packages independently
  • Experience conducting and documenting formal risk assessments

Preferences:

  • Experience validating cloud-based or SaaS systems under GAMP 5 Category 4/5
  • Familiarity with Veeva Vault, Kneat, or similar electronic validation platforms
  • Prior experience supporting FDA or EMA inspections in a CSV capacity
  • Background in biologics, clinical manufacturing, or combination products

Responsibilities:

  • Own the validation lifecycle for GxP-regulated computer systems
  • Work directly with quality, IT, and manufacturing teams to deliver compliant, audit-ready validation packages
  • Lead end-to-end validation of LIMS, ERP, and MES systems per 21 CFR Part 11 and GxP regulations
  • Author, execute, and review URS, FS, Validation Plans, IQ/OQ/PQ protocols, and Summary Reports
  • Manage periodic reviews and revalidation of existing validated systems
  • Coordinate with system owners, vendors, and IT to define scope, timelines, and deliverables
  • Apply GAMP 5 principles to classify systems and define risk-based validation strategies
  • Conduct formal risk assessments including FMEA and maintain site-level risk registers
  • Ensure risk controls are reflected in validation test scripts and traceability matrices
  • Assess computerized systems for data integrity compliance including audit trails, access controls, and electronic records
  • Evaluate and remediate 21 CFR Part 11 gaps in existing validated systems
  • Support data integrity investigations and respond to related audit findings
  • Serve as CSV SME during FDA, EMA, and client audits and inspections
  • Author and maintain SOPs, deviations, change controls, and CAPAs for validated systems
  • Stay current with 21 CFR Part 11, EU Annex 11, ICH Q9, and USP 1058 guidance