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

KBI Biopharma, Inc.

CSV Specialist II

Durham, NC · On-site

Responsible for supporting all aspects of the Computer Systems Validation (CSV) Lifecycle for the Validation Department to ensure all systems are in a qualified state suitable for the intended use.

Staffingine LLC

Validation Engineer

Raleigh, NC · On-site

Validation Engineer Job Location: Raleigh - North Carolina Job Type: Contract * Manage lab servers ... Perform system provisioning installation configuration and upgrades * Support daily lab operations ...

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KBI Biopharma, Inc.

CSV Specialist II

Durham, NC

Responsible for supporting all aspects of the Computer Systems Validation (CSV) Lifecycle for the Validation Department to ensure all systems are in a qualified state suitable for the intended use.

Corning

Division Quality Engineer I

Durham, NC

$69K - $89K/yr

Support the standardization of computer systems validation procedures, templates, and documentation practices across division manufacturing and laboratory facilities * Support implementation and ...

Staffingine LLC

Silicon Validation Engineer

Raleigh, NC · On-site

Silicon Validation Engineer Job Location: Raleigh NC Job Type: Contract * You will be responsible ... Bachelor's degree in electrical engineering, Computer Engineering, or a related field. * 7+ years ...

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Intellectt INC

"cleaning validation"

Holly Springs, NC · On-site

Role:CQV Engineer - Cleaning Validation Location: Holly Springs, NC Key Responsibilities: * Execute and document cleaning validation protocols per FDA/ICH guidelines (ALCOA principles). * Apply ...

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Computer System Validation information

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$10

$52

$83

How much do computer system validation jobs pay per hour?

As of Jul 1, 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
CSV Specialist II

CSV Specialist II

KBI Biopharma, Inc.

Durham, NC • On-site

Full-time

Posted 16 days ago

Job description

Responsible for supporting all aspects of the Computer Systems Validation (CSV) Lifecycle for the Validation Department to ensure all systems are in a qualified state suitable for the intended use. This will include authoring of protocols, test scripts, and data tables to facilitate collection, expert data analysis/verification, summary reporting, and conclusions regarding acceptance criteria for validation studies conducted for systems and re-qualifications.
Execute on implementation tasks, work prioritization and support escalation management activities while ensuring the highest level of compliance with regulatory agencies. Employee will track changes to the regulatory environment and implement processes and procedures enabling KBI to meet ongoing requirements such as 21CFR Part 11, EU Annex 11, and data integrity.
The role will also be generally responsible for maintaining and accessing the validation documentation archive to fulfill internal/external client and/or auditor requests. In addition, there will be tasks related to coordinating validation support for Quality Event processes related to Change Controls, Deviations, CAPAs, and Audit Observations.
Minimum Requirements:
  • Bachelor's degree in Engineering, Information Technology, or a related discipline.
  • 3-5 years of experience as a CSV Specialist or in a comparable role within the pharmaceutical or biotechnology industry.
  • Minimum of 3 years of hands-on experience with GAMP and 21 CFR Part 11 compliance, including software functional testing and application of regulatory guidance.
  • Demonstrated experience in developing and reviewing validation documentation, including procedures, protocols, risk assessments, and summary reports.
  • Working knowledge of the CSV lifecycle, including system risk assessment, protocol development and execution, deviation management, and final report authoring.
  • Familiarity with equipment control software and validation principles.
  • Ability to read and interpret technical documentation (e.g., P&IDs, engineering specifications, SOPs, and batch records).
  • Strong technical writing and communication skills, with the ability to present effectively to internal stakeholders.
  • Proven problem-solving and critical thinking abilities, with capability to analyze data and apply sound judgment in non-standard situations.
  • Proficiency in Microsoft Office applications (particularly Excel) and electronic document management systems.
  • Strong organizational, time management, and multitasking skills, with a focus on delivering high-quality, compliant documentation.
  • Basic mathematical and data analysis skills to support validation activities.
  • Ability to work effectively both independently and within a team environment.
  • Capable of meeting minimal physical requirements, including lifting up to 25 lbs.

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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