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Computer System Validation Jobs in Raleigh, NC (NOW HIRING)

Valspec

Validation Engineer (CQV)

Holly Springs, NC

Valspec--a global provider of system validation and lifecycle services--provides commissioning and qualification of computerized systems for clients in the Life Sciences industry. Established in 1999 ...

Valspec

Validation Engineer (CQV)

Raleigh, NC

Valspec--a global provider of system validation and lifecycle services--provides commissioning and qualification of computerized systems for clients in the Life Sciences industry. Established in 1999 ...

Novartis

Validation Engineer III

Durham, NC

$183K/yr

Support computer systems validation activities for global systems and applications * Collaborate with cross-functional teams to support audits, inspections, and project execution Essential ...

KBI Biopharma

ELN Administrator

Durham, NC · On-site

... to computer system validation and compliance. • Able to react to change productively and handle other essential tasks as assigned. Qualifications : Required : • Bachelor's degree in computer ...

Oxford Biomedica

Validation Engineer III

Durham, NC

Analytical instruments, Computer Systems (as applicable to complex instruments and manufacturing equipment),Equipment, Utilities, and Facilities. * Development of Validation Plans and Validation Plan ...

Oxford Biomedica

Validation Engineer III

Durham, NC · On-site

Analytical instruments, Computer Systems (as applicable to complex instruments and manufacturing equipment),Equipment, Utilities, and Facilities. * Development of Validation Plans and Validation Plan ...

Kelly Services

Quality Validation Manager

Raleigh, NC · On-site

$135K/yr

Responsible for managing the development and the execution of qualifications, validations, re-qualifications and re-validations for process and laboratory equipment, computer systems, utilities ...

KBI Biopharma, Inc.

ELN Administrator

Durham, NC · On-site

$84K - $115K/yr

Develop and maintain a current understanding of United States Food and Drug Administration (FDA) and European Medicines Agency (EMA) regulations as they pertain to computer system validation and ...

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Computer System Validation information

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How much do computer system validation jobs pay per hour?

As of Jul 22, 2026, the average hourly pay for computer system validation in Raleigh, NC is $52.80, according to ZipRecruiter salary data. Most workers in this role earn between $40.67 and $62.64 per hour, depending on experience, location, and employer.

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.

What is a Computer System Validation job?

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 the Computer System Validation position, 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 is the work of computer system validation?

Computer System Validation (CSV) is the process of ensuring that computer systems used in regulated environments function correctly and comply with industry standards. It involves documenting and testing software, hardware, and related processes to verify they meet specified requirements, often using validation protocols and tools. CSV is essential in industries like pharmaceuticals and healthcare to ensure data integrity and regulatory compliance.

What degree is best for cis jobs?

For Computer System Validation (CSV) roles, a bachelor's degree in computer science, information technology, life sciences, or engineering is typically preferred. Relevant certifications such as GxP or validation-specific training can enhance job prospects, and strong knowledge of regulatory requirements like FDA or EMA guidelines is beneficial.

What is the salary of SoC validation engineer?

The salary of a SoC validation engineer typically ranges from $80,000 to $130,000 annually, depending on experience, location, and company size. Professionals in this role often have skills in hardware description languages and verification tools, which can influence compensation.
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Computer System Validation jobs near you
Infographic showing various Computer System Validation job openings in Raleigh, NC as of July 2026, with employment types broken down into 100% Full Time. Highlights an 100% In-person job distribution, with an average salary of $109,822 per year, or $52.8 per hour.
6385- Senior CSV/CQV Engineer / Senior Validation Engineer 2

6385- Senior CSV/CQV Engineer / Senior Validation Engineer 2

Verista, Inc.

Durham, NC

Other

Posted 16 days ago

Job description

Position Summary

The CSV/CQV Engineer will support the commissioning, qualification, and validation of process equipment, utilities, facilities, and PAT systems. This role is responsible for all computerized system validation (CSV) and data integrity (DI) activities, working under the direction of the Validation Lead and alongside the CQV team.

General CSV Skills

  • Familiarity with global standards for computerized systems and data integrity.
  • Ability to classify systems as "simple" or "complex" using riskbased criteria to rightsize validation effort.
  • Experience authoring CSV deliverables: URS/FDS/DDS review, risk assessments, test protocols (IQ/OQ), and summary reports.
  • Supplier assessment execution for OEMprovided computerized systems.
  • Data integrity assessment using ALCOA+ principles, including audit trail, user roles, time sync (NTP), backup/restore, and archival.

ProjectSpecific CSV Responsibilities

CSV Deliverables

  • Author Data Integrity Assessments for each Direct Impact computerized system, defining roles/privileges, and confirming electronic records handling.
  • Assess and document how PAT result data integrates with the paperbased manufacturing batch record (MBR) interface, ensuring data integrity at the point of data transfer.
  • Perform supplier assessments for major OEM systems and PAT instruments.
  • Author configuration specifications for computerized systems where client templates are available or where vendor documentation is insufficient.
  • Write CSV sections within IQ/OQ protocols - access control, audit trail verification, time sync (NTP), backup/restore, and data flow tests.
  • Develop data flow diagrams for critical integrations:
  • Execute IQ/OQ CSV test scripts, including; User role and access control, Audit trail review, Time synchronization, Backup and restore, and Data flow and accuracy 
  • PAT integration testing
  • Document any deviations discovered during CSV testing, perform impact assessment, and track CAPAs to closure.

Required Qualifications

  • Bachelor's degree in engineering, computer science, or related field.
  • Minimum 5 years of CSV experience in GMP pharmaceutical or biotech environments.
  • Proven experience with equipmentlevel PLC/HMI validation (OEM systems) and historian connectivity.
  • Handson experience with PAT instrument integration (e.g., NIR, moisture analyzers) is a strong plus.
  • Must be local in or around RTP, must be able to work on site 100%.

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