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Computer System Validation Csv Jobs in Cary, NC (NOW HIRING)

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 ...

MDAEdge

LabWare LIMS-LES Developer

Raleigh, NC · On-site

... integration. • Familiarity with system validation (CSV), change control, and regulatory ... Bachelor's degree in Computer Science, Life Sciences, or a related field. Preferred : • ...

Indivior

Senior Engineer, Validation

Raleigh, NC

Streamline procedures for equipment and utility qualification and CSV using risk assessment and ... Working knowledge of process automation and computer system validation concepts, GAMP methodologies ...

Indivior PLC

Senior Engineer, Validation

Raleigh, NC · On-site

Streamline procedures for equipment and utility qualification and CSV using risk assessment and ... Working knowledge of process automation and computer system validation concepts, GAMP methodologies ...

GRIFOLS, S.A.

Manufacturing Digital Manager

Clayton, NC · On-site

Strong experience with data integrity principles, computer system validation (CSV), and GxP regulations * Demonstrated experience implementing or sustaining EBR/MES platforms. Preferred * Experience ...

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Computer System Validation Csv information

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

As of Sep 2, 2026, the average hourly pay for computer system validation csv in Cary, NC is $47.99, according to ZipRecruiter salary data. Most workers in this role earn between $36.06 and $59.66 per hour, depending on experience, location, and employer.

What is a computer system validation CSV?

A Computer System Validation (CSV) job involves ensuring that computerized systems used in regulated industries, such as pharmaceuticals and medical devices, comply with industry standards and regulatory requirements (e.g., FDA 21 CFR Part 11, GxP). CSV professionals develop validation protocols, conduct testing, and document system performance to ensure data integrity, reliability, and compliance. Their role is critical in maintaining system quality and avoiding regulatory risks.

What are the key skills and qualifications needed to thrive in computer system validation CSV?

To thrive as a Computer System Validation (CSV) professional, you need a solid understanding of computer science, regulatory compliance (such as FDA 21 CFR Part 11), and validation methodology, often supported by a degree in a scientific or technical field. Familiarity with documentation tools, validation protocols, and quality management systems, as well as certifications like PMP or Six Sigma, is highly beneficial. Strong attention to detail, problem-solving abilities, and effective communication skills enable effective cross-functional collaboration. Mastering these skills ensures accurate validation processes, regulatory compliance, and smooth project execution in highly regulated environments.

What are some typical challenges faced by computer system validation CSV professionals and how are they addressed?

Computer System Validation (CSV) professionals often encounter challenges such as keeping up with evolving regulations, managing complex documentation requirements, and ensuring robust communication between IT, quality assurance, and business teams. Navigating system upgrades while maintaining compliance with strict regulatory standards requires careful planning and thorough risk assessment. Successful candidates address these challenges by staying current with industry guidance, utilizing validation templates and checklists, and fostering strong teamwork across various departments. Building collaborative relationships and maintaining meticulous records help ensure both audit readiness and smooth project completion.

Is computer system validation a good field?

Computer System Validation (CSV) is a specialized field within regulated industries like pharmaceuticals and biotech, focusing on ensuring software and systems meet compliance standards such as GxP. It offers opportunities for professionals with skills in quality assurance, validation protocols, and regulatory requirements, often requiring certifications like GAMP or 21 CFR Part 11 knowledge. The field provides stable employment with growth potential, especially as compliance regulations become more stringent.

What are popular job titles related to Computer System Validation Csv jobs in Cary, NC?

For Computer System Validation Csv jobs in Cary, NC, the most frequently searched job titles are:

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

The top searched job categories for Computer System Validation Csv jobs in Cary, NC are:

What cities near Cary, NC are hiring for Computer System Validation Csv jobs?

Cities near Cary, NC with the most Computer System Validation Csv job openings:

Computer System Validation Csv jobs near you
Infographic showing various Computer System Validation Csv job openings in Cary, NC as of August 2026, with employment types broken down into 1% As Needed, 83% Full Time, 14% Part Time, and 2% Contract. Highlights an 91% Physical, 2% Hybrid, and 7% Remote job distribution, with an average salary of $99,819 per year, or $48 per hour.

Sr/Principal Computer Systems Validation Specialist

KBI Biopharma, Inc.

Durham, NC • On-site

$133K - $183K/yr

Full-time

Medical, Dental, Vision, Retirement, PTO

Re-posted 22 days ago

KBI Biopharma rating

6.5

Company rating: 6.5 out of 10

Based on 6 frontline employees who took The Breakroom Quiz

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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