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$86

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

As of Jun 29, 2026, the average hourly pay for computer system validation specialist in the United States is $54.32, according to ZipRecruiter salary data. Most workers in this role earn between $41.83 and $64.42 per hour, depending on experience, location, and employer.

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

To thrive as a Computer System Validation Specialist, you need expertise in computer science, regulatory compliance (such as FDA 21 CFR Part 11 and GxP), and a background in life sciences or IT, often supported by a relevant bachelor's degree. Familiarity with validation lifecycle documentation, risk management tools, and computerized system validation (CSV) software is essential. Strong analytical thinking, attention to detail, and effective communication skills help ensure thorough documentation and collaboration across departments. These abilities are crucial to maintain regulatory compliance, data integrity, and smooth system implementation in highly regulated industries.

What are some common challenges faced by Computer System Validation Specialists during project implementation?

Computer System Validation Specialists often encounter challenges such as managing tight project timelines, ensuring compliance with evolving regulatory standards, and coordinating with cross-functional teams like IT, QA, and business users. Navigating diverse documentation requirements and handling unexpected changes to system specifications can also be demanding. Effective communication, attention to detail, and proactive risk management are essential to successfully overcome these obstacles and deliver compliant, validated systems.

What Does a Computer System Validation Specialist Do?

A computer system validation specialist coordinates validation efforts for computer systems, hardware, and software, especially within a manufacturing setting, to ensure product quality. As a CSV specialist, your responsibilities include managing computer validation project activities and creating computer system planning documents and testing protocols. You also review test results and identify areas of improvement to implement changes. Other duties include providing technical expertise to customers and the validations department while communicating the validation plan and creating protocols. You may also ensure that each product is compliant with Current Good Manufacturing Practice (CGMP), Good Automated Manufacturing Practice (GAMP), and Code of Federal Regulations.

What does a Computer System Validation Specialist do?

A Computer System Validation Specialist ensures that computer systems used in regulated industries, such as pharmaceuticals or medical devices, comply with regulatory requirements and function as intended. They develop and execute validation protocols, document processes, and work closely with quality assurance and IT teams to maintain compliance. Their work helps guarantee data integrity, product quality, and patient safety by ensuring systems are reliable and audit-ready.

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

AspectComputer System Validation SpecialistQuality Assurance Specialist
CertificationsGxP, 21 CFR Part 11, CSV-specific trainingISO 9001, Six Sigma, QA certifications
Work EnvironmentPharmaceutical, biotech, regulated industriesManufacturing, software, healthcare sectors
Employer & Industry UsageRegulated industries requiring compliance documentationBroadly used across industries for process quality

The Computer System Validation Specialist focuses on ensuring computer systems meet regulatory standards through validation processes, primarily in regulated industries like pharma and biotech. In contrast, the Quality Assurance Specialist oversees overall quality processes, including audits and compliance, across various sectors. While both roles emphasize compliance and documentation, the CSV Specialist is more technical and specific to computer systems validation, whereas the QA Specialist has a broader scope in quality management.

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Computer System Validation Specialist jobs near you
Infographic showing various Computer System Validation Specialist job openings in the United States as of June 2026, with employment types broken down into 2% As Needed, 65% Full Time, 31% Part Time, 1% Temporary, and 1% Contract. Highlights an 93% Physical, 2% Hybrid, and 5% Remote job distribution, with an average salary of $112,983 per year, or $54.3 per hour.
Computer System Validation Engineer

Computer System Validation Engineer

Avid Bioservices

Tustin, CA • On-site

$82K - $104K/yr

Full-time

Medical, Dental, Vision, Retirement, PTO

Posted 11 days ago

Job description

Looking to join a passionate team dedicated to developing and manufacturing life-saving biopharmaceuticals? Avid Bioservices is a leading clinical and commercial biologics CDMO focused on creating innovative solutions to meet the needs of our clients and improve patient outcomes.
Your Role:
The Computer System Validation Engineeris responsible for providing technical validation support for manufacturing equipment, laboratory instruments, computer systems, networks, and software that have been newly installed, upgraded, replaced and/or modified in the cGMP Manufacturing Facility as well as its related manufacturing support areas, which may include Facilities/ Engineering, Quality Assurance, Supply Chain, and Quality Control.
  • Review and help author User Requirement Specification (URS) and/or Requirement Specification documents for manufacturing equipment/systems and processes
  • Generate and execute Installation, Operational and Performance/Process qualification (IQ, OQ, PQ) protocols, engineering studies and final reports thatcomply with corporate and regulatory requirements.
  • Coordinate and oversee validation protocol execution or validation activities with cross-functional departments.
  • Evaluate and analyze qualification data collected during projects, while verifying acceptability of the data and compliance with the approved protocol.
  • Ensure any deviations to protocols and/or deviations to acceptance criteria are adequately addressed, documented and reviewed by the Validation Committee
  • Provide input and assist on the development of validation policies and procedures.
  • Effectively interact and provide validation guidance to other departments.
  • Assist department manager in developing realistic time and resource requirements for validation activities in support of company expectation.
  • Provide input and assist in change control assessment and Part 11 assessment for validated systems.
  • Review Standard Operating Procedures (SOPs) and ensure the operational parameters described in the SOP for the equipment reflects validated conditions.
  • Assist department manager on other types of projects/managerial responsibilities as needed
Minimum Qualifications:
  • BA/BS in science (such as Biology, Microbiology, Biochemistry, Chemistry), Engineering (such as Electrical, Electronics, Computer Science) or other equivalent technology related field.
  • Minimum of 3 years' work experience in biopharmaceutical/pharmaceutical manufacturing environment of which 1 year is directly involved in validations.
Position Type/Expected Hours of Work:
This role is a full-time position. Days and hours of work are Monday through Friday, 8am to 5pm PST, unless otherwise stated by Supervisor.
Compensation:
We offer competitive compensation packages for this role, including a base salary, performance-based bonuses, and comprehensive benefits such as health, dental, and vision insurance, 401(k) matching, and paid time off.
The compensation range for this role is $82,000- $104,400 annually depending on experience and qualifications. Additionally, we offer opportunities for career growth and development as well as a supportive and inclusive work environment.
Who you are:
  • You have a "bring it on!" team player approach and an unshakable positive attitude, always ready to tackle anything that comes your way.
  • Your written and verbal skills are out of this world, and you communicate with clarity and confidence.
  • You have exceptional multitasking skills and an unparalleled attention to detail that ensure the smooth running of everything.
  • You are a master at building relationships, capable of establishing connections with anyone, be it team members, clients, vendors, or suppliers.
Physical Demands & Work Environment:
In this dynamic role, expect a blend of regular activities like sitting, standing, and walking, with occasional physically engaging tasks such as lifting objects up to 25 pounds. The work environment might expose you to electrical shocks, toxic chemicals, vibrations, or loud noise levels occasionally. However, reasonable accommodations are available to enable individuals with different abilities to perform effectively, ensuring a supportive and adaptable work setting. Your visual acuity, including close, distance, and color vision, will be essential in navigating through the diverse day-to-day demands of this position.
Employment Type: Full-Time

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