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

Valspec

Validation Engineer

Raleigh, NC

Requirements * 3+ years of Computer System Validation (CSV) experience with process control, SCADA and automation systems, MES and data integration systems (Emerson DeltaV and/or Syncade experience ...

Valspec

Equipment Validation Engineer

Raleigh, NC · On-site

The ideal candidate has experience leading the equipment CQV efforts of a team that also includes computer system validation engineers and specialists. Key Responsibilities: * Lead and execute CQV ...

MedPharm

QA Systems Manager - eQMS & CSV

Durham, NC · On-site

Training in Computer System Validation in a Pharmaceutical GMP environment and familiarity with GAMP 5 with minimum 5 years' experience working in the pharmaceutical industry preferred. * Familiar ...

MedPharm

QA Systems Manager - eQMS & CSV

Durham, NC · On-site

Training in Computer System Validation in a Pharmaceutical GMP environment and familiarity with GAMP 5 with minimum 5 years' experience working in the pharmaceutical industry preferred. * Familiar ...

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$52

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How much do computer system validation jobs pay per hour?

As of Jun 7, 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 are the most commonly searched types of Computer System Validation jobs in Raleigh, NC? The most popular types of Computer System Validation jobs in Raleigh, NC are:
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Computer System Validation jobs near you
Infographic showing various Computer System Validation job openings in Raleigh, NC as of May 2026, with employment types broken down into 80% Full Time, 8% Part Time, 4% Temporary, and 8% Contract. Highlights an 100% In-person job distribution, with an average salary of $109,822 per year, or $52.8 per hour.
Sr/Principal Computer Systems Validation Specialist

Sr/Principal Computer Systems Validation Specialist

KBI Biopharma, Inc.

Durham, NC • On-site

$133K - $183K/yr

Full-time

Medical, Dental, Vision, Retirement, PTO

Posted 25 days ago

Job description

This individual will provide thought-leadership, expertise, and management of managed validation services to the IT Validation & Compliance infrastructure in a Contract Development and Manufacturing Organization (CDMO) setting. Individual will be responsible for the validation review and approval of enterprise software validation lifecycle deliverables and the validation technical oversite of change controls,CAPAs, and deviations associated with enterprise software. Working closely with partners in Quality Validation, this individual provides strategic and technicalexpertise for all global software validation related matters, including assurance thatall aspects comply with cGMPs, legal, regulatory requirements, and the KBI internal requirements.

Job Responsibilities:

  • Provide oversight of enterprise software validation from a global perspective.

  • Provide validation direction, guidance, review, and approval for validation lifecycle deliverables of enterprise software projects.

  • Provide oversight and management to validation managed services for associated projects

  • Provide validation review and approval of enterprise software change controls, CAPAs, and deviations.

  • Provide support for data integrity global initiatives.

  • Provide expertise and input for global Policies, SOPs, and Templates for IT Enterprise Software

This position will be based in Durham, NC and will require a regular site presence.

Minimum Requirements:

  • (Principal - BS/MS and 15+ years/ Senior - BS/MS and 8+ years) experience in a cGMP environment in a computer systems validation role with demonstrated career growth and accomplishments.

  • Experience in Data Integrity, computer system validation/IT quality in an FDA regulated manufacturing environment. Demonstrated expert knowledge of 21CFR, Part 11, and/or EU Annex 11 as well as current regulatory guidance on Data Integrity.

Salary Range:

$118,000 - $162,800 (Senior)

$133,000 - $183,700 (Principal)

Salary range provided per current averages and expectations. The salary and job title for this opening will be based on the selected candidate's qualifications and experience and may be outside this range. KBI has a robust total rewards strategy which includes an annual bonus structure for all employees, medical, dental, and vision coverage, paid PTO and holidays, Sabbatical program, 401K matching with 100% vesting in 60 days and employee recognition programs.

KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply.

I understand that neither the completion of this application nor any other part of my consideration for employment establishes any obligation for KBI Biopharma, Inc. to hire me. If I am hired, I understand that either KBI Biopharma, Inc. or I can terminate my employment at any time and for any reason, with or without cause and without prior notice. I understand that no representative of KBI Biopharma, Inc. has the authority to make any assurance to the contrary.

I attest with my signature below that I have given to KBI Biopharma, Inc. true and complete information on this application. No requested information has been concealed. I authorize KBI Biopharma, Inc. to contact references provided for employment reference checks. If any information I have provided is untrue, or if I have concealed material information, I understand that this will constitute cause for the denial of employment or immediate dismissal.

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