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Computer System Validation Engineer Jobs (NOW HIRING)

Graphcore

Staff System Validation Engineer

Austin, TX · On-site

Job Summary We are seeking a Staff System Validation Engineer to design and implement validation tests for Arm-based data center SoCs using a combination of open-source benchmarking tools and custom ...

Apple

SerDes System Validation Engineer

Cupertino, CA

$126K - $220K/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 ...

Apple

SerDes System Validation Engineer

Cupertino, CA

$181K - $318K/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 ...

Graphcore

Staff System Validation Engineer

Austin, TX · Hybrid

Job Summary We are seeking a Staff System Validation Engineer to design and implement validation tests for Arm-based data center SoCs using a combination of open-source benchmarking tools and custom ...

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

As of Jun 11, 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.

Is CSV a skill?

In the context of a Computer System Validation Engineer, knowledge of CSV typically refers to Computer System Validation processes rather than a specific skill. However, familiarity with validation protocols, documentation, and related tools is essential for the role. Proficiency in using validation software and understanding regulatory requirements are valuable skills for CSV professionals.

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, such as pharmaceuticals or biotech, meet required standards for quality and compliance. They develop validation protocols, execute testing, document results, and maintain validation documentation to verify systems function correctly and consistently. This role often involves working with validation tools, regulatory guidelines, and quality assurance processes.

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 computer system validation?

The salary of a Computer System Validation Engineer typically ranges from $70,000 to $120,000 annually, depending on experience, location, and industry. Professionals with certifications like GAMP or experience with validation tools may command higher salaries, especially in regulated environments such as pharmaceuticals or biotech.

What engineers make $500,000?

Highly experienced computer system validation engineers working in the pharmaceutical or biotech industries, especially those with advanced certifications and specialized skills, can reach or exceed a $500,000 annual salary. Such roles often require extensive expertise, leadership responsibilities, and sometimes involve consulting or management positions. Salaries at this level are typically seen in senior or executive roles within large organizations or specialized consulting firms.
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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 97% Full Time, 2% Contract, and 1% Nights. Highlights an 87% Physical, 5% Hybrid, and 8% Remote job distribution, with an average salary of $107,747 per year, or $51.8 per hour.

Computer System Validation (CSV) Engineer

Kashiv BioSciences, LLC

Piscataway, NJ

Other

Posted 9 days ago

Job description

Description


Position Type: Full-time Employee (FTE)

Location: Piscataway, NJ (onsite - physical presence required)

Reports To: Sr. Director of IT

Work Authorization: Must be authorized to work in the U.S. without sponsorship, now or in the future


Position Summary


We are seeking an experienced CSV Engineer to support validation activities across a broad portfolio of regulated systems, including laboratory instrumentation, engineering and manufacturing equipment, and enterprise platforms. This role serves as a liaison across Quality, IT, Laboratory, and Manufacturing functions, ensuring systems are validated and maintained in compliance with 21 CFR Part 11, GxP, and EMA requirements.


Essential Duties & Responsibilities

  • Plan, author, and execute validation deliverables (VP, URS, FS, DS, IQ/OQ/PQ, Traceability Matrix, Validation Summary Reports) across assigned systems
  • Support CSV activities across lab instruments (HPLC, GC, spectrophotometers, balances, etc.), engineering and manufacturing equipment, and enterprise systems including Caliber LIMS, SAP, and BMRAM
  • Partner with system owners, QA, and IT to maintain systems in a validated state through change control and periodic review
  • Execute risk assessments and data integrity assessments aligned with ALCOA+ principles
  • Support audits, inspections, CAPA investigations, and deviations related to computerized systems
  • Collaborating with senior validation leads and SMEs to drive consistent practices across sites

Requirements

Position Requirements and Qualifications

  • Bachelor's degree in Life Sciences, Engineering, or IT; OR equivalent laboratory experience in a life sciences environment
  • Minimum 5 years of CSV experience in a GxP-regulated environment
  • Working knowledge of 21 CFR Part 11, EU Annex 11, and EMA guidance
  • Hands-on experience authoring and executing IQ/OQ/PQ protocols
  • Experience validating at least two of: laboratory instruments, engineering/manufacturing equipment, LIMS, SAP, or CMMS/calibration platforms (e.g., BMRAM)

Experience:  

  • Minimum 5 years of CSV experience in a GxP-regulated environment
  • Working knowledge of 21 CFR Part 11, EU Annex 11, and EMA guidance
  • Hands-on experience authoring and executing IQ/OQ/PQ protocols
  • Experience validating at least two of: laboratory instruments, engineering/manufacturing equipment, LIMS, SAP, or CMMS/calibration platforms (e.g., BMRAM)

Specialized Knowledge and Skills: 

  • Familiarity with GAMP 5 principles and risk-based validation
  • Exposure to Caliber LIMS
  • Exposure to SAP (QM, MM, PP) in a GxP context
  • Experience with BMRAM or equivalent CMMS/calibration systems
  • Prior experience acting as a liaison across IT, Quality, Lab, and Manufacturing teams

Work Environment & Physical Demands:

  • This is an on-site position
  • Must be able to work extended hours or weekend hours, as may be required.

Noise:

  • No extraordinary noise levels.

Standing/Lifting:

  • Very unlikely, but can be able to lift at least 20 lbs.

Visual:

  • No extraordinary requirements.

Stress:

  • High-paced demanding environment to meet ambitious project goals.

Travel:

  • Moderate domestic travel may be required.

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