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Csv Validation Engineer 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 ... Bachelor's degree in Engineering, Information Technology, or a related discipline. * 3-5 years of ...

Corning

Division Quality Engineer I

Durham, NC · On-site

$69K - $89K/yr

Drive continuous improvement in CSV processes, validation efficiency, template standardization, and ... Certified Quality Engineer recognition by ASQ. * Certified Green or Black Belt recognition by ASQ.

Vulcan Elements

Sr. Controls Engineer

Durham, NC

$93K - $123K/yr

As the Sr. Controls Engineer (FAT/CSV) you will lead automation acceptance and commissioning for a ... Integrate with Quality's validation system - protocols live in Quality's framework and carry ...

MDAEdge

LabWare LIMS-LES Developer

Raleigh, NC · On-site

MDAEdge is looking for a skilled LabWare LIMS-LES Developer to support and enhance their LabWare ... validation (CSV), change control, and regulatory requirements (FDA 21 CFR Part 11, GxP). • Good ...

Fujifilm

ServiceNow, Product Owner

Holly Springs, NC

$46.75 - $64.25/hr

Ensure compliance in a regulated environment; lead/participate in Computer Software Validation (CSV ... Bachelor's degree in Information Technology, Computer Science, Engineering, or related field; or ...

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Csv Validation Engineer information

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How much do csv validation engineer jobs pay per hour?

As of Aug 10, 2026, the average hourly pay for csv validation engineer in Raleigh, NC is $50.54, according to ZipRecruiter salary data. Most workers in this role earn between $38.32 and $61.44 per hour, depending on experience, location, and employer.

What are the key skills and qualifications needed to thrive as a CSV validation engineer, and why are they important?

To thrive as a CSV (Computer System Validation) Validation Engineer, you need expertise in validation methodologies, regulatory compliance (such as FDA 21 CFR Part 11), and a background in life sciences or engineering. Familiarity with validation tools, documentation systems, and quality management software is typically required, along with knowledge of industry standards like GAMP 5. Strong attention to detail, analytical thinking, and effective communication skills set outstanding candidates apart. These competencies ensure validated systems meet regulatory requirements, maintain data integrity, and support safe, compliant operations in regulated environments.

What is a CSV validation engineer?

CSV Validation Engineers are professionals responsible for ensuring that computerized systems used in regulated industries, such as pharmaceuticals or biotechnology, comply with industry standards and regulations. CSV stands for Computer System Validation, which involves testing and documenting that systems function as intended and meet regulatory requirements for data integrity and security. These engineers typically create validation protocols, perform risk assessments, and support audits. Their work is crucial to ensure that electronic records and processes are reliable, traceable, and meet legal and industry guidelines.

What are some common challenges faced by a CSV validation engineer when working with cross-functional teams?

As a CSV Validation Engineer, one common challenge is ensuring clear communication and understanding between IT, QA, and business process teams regarding regulatory requirements and validation protocols. Misalignment on validation deliverables or timelines can occur, especially when teams have differing priorities or levels of familiarity with compliance frameworks. Proactively facilitating discussions, clarifying documentation, and providing training on Computer System Validation standards can help bridge gaps and keep projects on track.

What is the difference between Csv Validation Engineer vs Data Quality Analyst?

AspectCsv Validation EngineerData Quality Analyst
Required CredentialsBachelor's in Computer Science, Data Management, or related field; familiarity with data validation toolsBachelor's in Data Science, Statistics, or related; certifications like CDMP are common
Work EnvironmentData teams, software development, quality assuranceData analysis, reporting, data governance teams
Industry UsageTech, finance, healthcare, where data validation is criticalBusiness intelligence, analytics, data management sectors

The Csv Validation Engineer primarily focuses on validating and ensuring the accuracy of CSV data files through automated tools and scripts. In contrast, the Data Quality Analyst evaluates overall data quality, identifies issues, and implements data governance practices. Both roles require strong analytical skills and familiarity with data management, but their core responsibilities differ in scope and focus.

What are popular job titles related to Csv Validation Engineer jobs in Raleigh, NC? For Csv Validation Engineer jobs in Raleigh, NC, the most frequently searched job titles are:
What job categories do people searching Csv Validation Engineer jobs in Raleigh, NC look for? The top searched job categories for Csv Validation Engineer jobs in Raleigh, NC are:
What cities near Raleigh, NC are hiring for Csv Validation Engineer jobs? Cities near Raleigh, NC with the most Csv Validation Engineer job openings:
Csv Validation Engineer jobs near you
Infographic showing various Csv Validation Engineer job openings in Raleigh, NC as of August 2026, with employment types broken down into 92% Full Time, 2% Part Time, and 6% Contract. Highlights an 87% Physical, 4% Hybrid, and 9% Remote job distribution, with an average salary of $105,133 per year, or $50.5 per hour.

CSV Specialist II

KBI Biopharma, Inc.

Durham, NC • On-site

Full-time

Re-posted 23 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

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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