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Computer System Validation Specialist Jobs (NOW HIRING)

AMRI

Validation Specialist III

Albuquerque, NM · On-site

Validation Specialist III in Albuquerque, NM Build your future at Curia, where our work has the ... system, and computer system validations in accordance with cGMP, FDA regulations, and industry ...

Curia, Inc.

Validation Specialist III

Albuquerque, NM · On-site

Validation Specialist III in Albuquerque, NM Build your future at Curia, where our work has the ... system, and computer system validations in accordance with cGMP, FDA regulations, and industry ...

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Computer System Validation Specialist information

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

As of Aug 10, 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 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 $112,983 per year, or $54.3 per hour.

Computer System Validation Engineer

Stark Pharma Solutions Inc

Indianapolis, IN • On-site

Contractor

Re-posted 13 days ago

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