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Computer System Validation Jobs in Wake Forest, NC

Deloitte

System Test and Validation Lead

Raleigh, NC · On-site +1

Bachelor's degree in business, information systems, computer science, engineering, or equivalent experience; 6+ years of experience in computer system validation in a life sciences environment ...

Deloitte

System Test and Validation Lead

Raleigh, NC · On-site +1

Bachelor's degree in business, information systems, computer science, engineering, or equivalent experience; 6+ years of experience in computer system validation in a life sciences environment ...

Deloitte

System Test and Validation Lead

Raleigh, NC · On-site +1

Bachelor's degree in business, information systems, computer science, engineering, or equivalent experience; 6+ years of experience in computer system validation in a life sciences environment ...

PSC Biotech

Senior Validation Engineer

Durham, NC · On-site

$120K - $140K/yr

Support Computer System Validation (CSV) activities. * Perform risk assessments and apply risk-based validation methodologies throughout the system lifecycle. * Collaborate with cross-functional ...

PSC Biotech

Senior Validation Engineer

Durham, NC

Support Computer System Validation (CSV) activities. Perform risk assessments and apply risk-based validation methodologies throughout the system lifecycle. Collaborate with cross-functional ...

PSC Biotech

Senior Validation Engineer

Durham, NC · On-site

Support Computer System Validation (CSV) activities. * Perform risk assessments and apply risk-based validation methodologies throughout the system lifecycle. * Collaborate with cross-functional ...

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Computer System Validation information

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How much do computer system validation jobs pay per hour?

As of Aug 17, 2026, the average hourly pay for computer system validation in Wake Forest, NC is $46.59, according to ZipRecruiter salary data. Most workers in this role earn between $35.87 and $55.24 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 software and systems meet compliance standards such as GxP. It involves documentation, testing, and validation of computer systems, often requiring knowledge of regulatory requirements and validation tools. The field offers stable employment opportunities and career growth for professionals with technical skills and certifications like GAMP or 21 CFR Part 11 compliance.

What are popular job titles related to Computer System Validation jobs in Wake Forest, NC?

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What job categories do people searching Computer System Validation jobs in Wake Forest, NC look for?

The top searched job categories for Computer System Validation jobs in Wake Forest, NC are:

What cities near Wake Forest, NC are hiring for Computer System Validation jobs?

Cities near Wake Forest, NC with the most Computer System Validation job openings:

Computer System Validation jobs near you
Infographic showing various Computer System Validation job openings in Wake Forest, NC as of August 2026, with employment types broken down into 1% As Needed, 82% Full Time, 15% Part Time, and 2% Contract. Highlights an 91% Physical, 2% Hybrid, and 7% Remote job distribution, with an average salary of $96,906 per year, or $46.6 per hour.

Computer System Validation Engineer

Katalyst Healthcares and Lifesciences

Raleigh, NC • On-site

Other

Posted 3 days ago

New

Job description

Job Description:
  • We are seeking a Computer System Validation (CSV) Engineer for a global pharmaceutical client. This role will work cross-functionally to lead and execute validation activities for GxP electronic systems and applications.
  • The CSV Engineer will partner with Business Owners, Technical Owners, and Quality teams to create and manage validation deliverables throughout the validation lifecycle.
  • The primary responsibility is to ensure that validation activities supporting Manufacturing Execution Systems (MES) are documented in accordance with applicable procedures and regulatory requirements.
Roles & Responsibilities:
  • uthor, review, and/or approve applicable CSV documentation.
  • ssist Business Owners and Technical Owners during test execution, document test failures, and ensure testing aligns with internal procedures.
  • ssist Business Owners and Technical Owners in developing requirements and specifications for computerized systems used in GxP operations.
  • Support validation activities for Manufacturing Execution Systems (MES).
  • Develop and maintain CSV documentation including Validation Plans, Requirements, Specifications, Assessments, Test Scripts (IQ/OQ/PQ or equivalent), Summary Reports, Trace Matrices, and SOPs.
  • Ensure compliance with cGMP, GxP, GAMP, SDLC regulations, 21 CFR Part 11, and Good Documentation Practices.
  • Support validation of pharmaceutical manufacturing and laboratory systems used in biologics and clinical manufacturing environments.
  • Utilize IT service management platforms to support incident, problem, and change management activities.
  • Work with Business Quality Management Systems and related validation processes.
Requirements:
  • Bachelor's degree in Life Sciences, Engineering, IT, or a related discipline, or equivalent industry experience.
  • Minimum 4+ years of direct experience in Computer System Validation (CSV).
  • Strong knowledge of GAMP and risk-based validation approaches.
  • Good understanding of electronic records and electronic signatures.
  • Strong knowledge of Manufacturing Execution System (MES) validation.
  • Familiarity with MES systems such as Emerson Syncade, ERP systems such as SAP or Oracle, and EBR systems such as InfoBatch.
  • Strong experience developing CSV documentation, including Validation Plans, Requirements, Specifications, Assessments, Test Scripts, Summary Reports, Trace Matrices, and SOPs.
  • Knowledge of pharmaceutical, manufacturing, and laboratory systems supporting biologics and clinical manufacturing.
  • Experience with IT service management platforms such as ServiceNow.
  • Exposure to Business Quality Management Systems such as Veeva.

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