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ClifyX

Computer system Validation Tester

Somerset, NJ · On-site

ClifyX is seeking a Computer System Validation Tester to ensure compliance with industry standards in computerized systems validation. The role involves performing risk assessments, drafting ...

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Computer System Validation information

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How much do computer system validation jobs pay per hour?

As of Sep 14, 2026, the average hourly pay for computer system validation 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 is a computer system validation?

A Computer System Validation (CSV) job involves ensuring that computer systems used in regulated industries, such as pharmaceuticals and medical devices, meet compliance and regulatory requirements. CSV professionals develop and execute validation protocols to confirm that software, hardware, and processes function as intended and maintain data integrity. They work with quality assurance, IT, and regulatory teams to document compliance with standards like FDA 21 CFR Part 11 and GxP. This role is critical in maintaining system reliability, product quality, and patient safety.

What are the key skills and qualifications needed to thrive in computer system validation, and why are they important?

To excel in Computer System Validation, candidates typically need a background in computer science, engineering, or life sciences, with expertise in validating software and systems in regulated environments such as pharmaceuticals or medical devices. Familiarity with tools like validation documentation software, GAMP 5 guidelines, FDA 21 CFR Part 11 regulations, and potentially certifications like CSV Professional or Six Sigma is highly valued. Strong attention to detail, analytical thinking, and effective communication skills help professionals work collaboratively and document findings precisely. These abilities ensure compliance, data integrity, and the reliability of computerized systems critical to safety and quality.

What are some typical challenges faced in computer system validation roles?

Professionals in Computer System Validation often encounter challenges such as keeping up with evolving regulatory requirements, ensuring complete and accurate documentation, and coordinating with cross-functional teams to implement validation protocols. Balancing thoroughness with project deadlines can also be demanding, as every validation step must stand up to external audits. However, these challenges provide valuable experience, strengthen project management abilities, and emphasize teamwork—key attributes that support career advancement into validation leadership or quality assurance roles.

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 professionals with skills in validation protocols, regulatory requirements, and tools like GxP and 21 CFR Part 11. The field provides steady employment, career growth, and the chance to work on critical quality assurance processes.
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Computer System Validation jobs near you
Infographic showing various Computer System Validation job openings in the United States as of September 2026, with employment types broken down into 67% Full Time, 13% Temporary, and 20% Contract. Highlights an 87% In-person, and 13% Remote job distribution, with an average salary of $112,983 per year, or $54.3 per hour.

Computer System Validation Specialist

Wilmington, NC • On-site

Vance Airscoop
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Other

Posted 14 days ago

Job description

Quality Chemical Laboratories (QCL), a leading Pharmaceutical testing and manufacturing laboratory in Wilmington, is seeking a qualified candidate for the position of Computer System Validation Specialist.

Responsibilities:
  • Performs and leads computer system validation projects related to authoring and executing validation documentation for laboratory instruments/equipment and systems according to the ISPE GAMP 5 Validation Life Cycle. Documentation includes Computer System Validation Plan, Risk Assessment, IQ, OQ, PQ, Test Scripts, Summary reports, Requirements Traceability Matrix (RTM), Periodic Review of Computer Systems, and Data Integrity Assessment.
  • Track and resolve deviations/exceptions during qualification activities.
  • Work with company management to implement changes and upgrades to computer systems
  • Work with vendors on purchasing and planning for new lab equipment/software upgrades, review vendor protocols/design specifications
  • Communicate Computer System Validation approaches and requirements during audits.
  • Review validated systems to assess need for further enhancements, validation, or system upgrades/fixes
Qualifications:
  • Two (2) years of experience with Computer System Validation in GxP environment (preferably pharmaceutical industry).
  • Experience in writing computer system test scripts, validation protocols and summary reports
    Knowledge of Regulatory Requirements, 21CFR11, Data Integrity Guidance, GAMP and industry best practices for validation to complete tasks
  • Proficient in analyzing and troubleshooting problems, identifying solutions, recommending, and implementing methods, procedures and/or techniques for resolution
  • Capable of managing multiple sub-projects, duties and tasks
  • Effective at communicating clearly and concisely, both orally and in writing
  • Able to work both independently and as a member of a cross-functional project team

Quality Chemical Laboratories (QCL) is a rapidly growing pharmaceutical testing and manufacturing lab in Wilmington, NC. We are seeking highly motivated candidates for multiple positions throughout the company in the areas of analytical data review, LabWare LIMS development/configuration/validation, Document Control, Computer System Validation and Data Integrity Specialists, Scientists (all levels) with experience in Mass Spec, LC, GC, QC compendial testing, Wet Chemistry, Microbiology, Sterility, Synthetic Chemistry, Biotech, Pharmaceutical Formulation and Manufacturing (requires knowledge of manufacturing equipment), Validation Engineers, Metrology, Report Generation, Sample Log-In Associates, and HVAC Technicians. Special attention given to candidates with an advanced degree in Chemistry or related science and experience in method development/validation. Special consideration also given to experienced GMP data reviewers.

QCL offers competitive salaries commensurate with experience and an excellent benefits package, as well as great potential for career advancement and leadership in a rapidly growing company. We now also offer subsidized childcare at our newly acquired childcare facility.

QCL is an equal opportunity employer.

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