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Csv Engineer Jobs in Raleigh, NC (NOW HIRING)

KBI Biopharma, Inc.

CSV Specialist II

Durham, NC · On-site

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 ...

KBI Biopharma, Inc.

CSV Specialist II

Durham, NC · On-site

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 ...

Corning

Division Quality Engineer I

Durham, NC · On-site

$69K - $89K/yr

Author, review, execute, and approve CSV lifecycle documentation, including: * Ensure computerized ... Partner with IT, Automation, Quality, Engineering, and system owners to support implementation ...

Orise

Senior MES Engineer

Raleigh, NC · On-site

$101K - $139K/yr

Job Summary : Orise is seeking a Senior MES Engineer to support the expansion of their ... CSV, and regulated documentation practices • Knowledge of ISA-88 / ISA-95 standards and ...

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All JobsCsv Engineer JobsCsv Engineer Jobs in Raleigh, NC

Csv Engineer information

See Raleigh, NC salary details

$35.2K

$97.1K

$134.4K

How much do csv engineer jobs pay per year?

As of Jul 13, 2026, the average yearly pay for csv engineer in Raleigh, NC is $97,143.00, according to ZipRecruiter salary data. Most workers in this role earn between $75,200.00 and $113,800.00 per year, depending on experience, location, and employer.

What engineer makes 500,000 a year?

Highly experienced engineers in specialized fields such as software engineering, data engineering, or systems architecture can earn salaries of $500,000 or more annually, especially with senior roles, bonuses, and stock options. These roles often require advanced skills, certifications, and extensive industry experience.

How much does a CSV engineer make?

A CSV engineer's salary typically ranges from $70,000 to $120,000 annually, depending on experience, location, and industry. Skills in data management, scripting, and familiarity with database tools can influence earning potential.

What is a CSV Engineer job?

A CSV (Computer System Validation) Engineer is responsible for ensuring that computer systems used in regulated industries, such as pharmaceuticals and medical devices, comply with regulatory requirements. They develop validation protocols, perform testing, document results, and ensure adherence to industry standards like FDA 21 CFR Part 11 and GAMP 5. Their goal is to confirm that software and hardware systems function correctly, maintain data integrity, and meet compliance requirements.

What does a CSV engineer do?

A CSV engineer specializes in designing, developing, and maintaining systems that process and manage data stored in CSV (comma-separated values) format. They often work with data integration, scripting, and database tools to ensure accurate data handling and transformation for analysis or application use.

What are the common challenges faced by a CSV Engineer in the pharmaceutical or medical device industry?

CSV Engineers in the pharmaceutical or medical device industry often face the challenge of keeping up with evolving regulatory requirements and ensuring all computerized systems remain compliant throughout their lifecycle. Managing comprehensive documentation, coordinating with multiple departments, and troubleshooting complex system changes can add to the workload. Successful CSV Engineers are proactive about staying informed of regulatory updates, are highly organized, and collaborate closely with Quality Assurance, IT, and operations teams. This dynamic environment offers the opportunity to learn continuously, develop expertise in validation best practices, and advance into leadership or specialized quality roles.

What is the salary of a CSV engineer?

The salary of a CSV engineer typically ranges from $70,000 to $120,000 annually, depending on experience, location, and industry. Skilled professionals with expertise in data processing, scripting, and database management tend to earn higher salaries.

What are the key skills and qualifications needed to thrive in the Csv Engineer position, and why are they important?

To thrive as a CSV Engineer (Computer System Validation Engineer), you need a solid understanding of validation principles, regulatory compliance (such as FDA 21 CFR Part 11), and a relevant degree in life sciences, engineering, or information technology. Familiarity with validation lifecycle documentation, risk assessment tools, and industry-standard systems like SAP, LIMS, and TrackWise is highly valued, as are certifications such as GAMP or Six Sigma. Strong attention to detail, analytical thinking, and excellent communication skills help CSV Engineers collaborate efficiently with cross-functional teams and ensure thorough documentation. These skills are crucial to guarantee that computerized systems in regulated industries meet compliance requirements, supporting product quality and patient safety.

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Csv Engineer jobs near you
Infographic showing various Csv Engineer job openings in Raleigh, NC as of July 2026, with employment types broken down into 2% As Needed, 81% Full Time, 8% Part Time, 1% Temporary, and 8% Contract. Highlights an 83% Physical, 4% Hybrid, and 13% Remote job distribution, with an average salary of $97,143 per year, or $46.7 per hour.
6385- Senior CSV/CQV Engineer / Senior Validation Engineer 2

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

Verista, Inc.

Durham, NC • On-site

Other

Re-posted 8 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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