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Csv Validation Engineer Jobs (NOW HIRING)

Genezen

Sr. CSV Validation Engineer

Lexington, MA

$115K - $140K/yr

... in Engineering, Computer Science or related discipline Desired ON-THE-JOB EXPERIENCE 7+ years of Computer System Validation experience Desired KNOWLEDGE, SKILLS AND EXPERIENCE In depth CSV ...

Genezen

Sr. CSV Validation Engineer

Lexington, MA

$115K - $140K/yr

... in Engineering, Computer Science or related discipline Desired ON-THE-JOB EXPERIENCE 7+ years of Computer System Validation experience Desired KNOWLEDGE, SKILLS AND EXPERIENCE In depth CSV ...

Genezen

Sr. CSV Validation Engineer

Lexington, MA · On-site

$115K - $140K/yr

... in Engineering, Computer Science or related discipline Desired ON-THE-JOB EXPERIENCE 7+ years of Computer System Validation experience Desired KNOWLEDGE, SKILLS AND EXPERIENCE In depth CSV ...

Deegit Inc

CSV Validation

Lexington, MA · On-site

Company Description CSV Validation with Application Testing Qualifications Additional Information All your information will be kept confidential according to EEO guidelines.

Intellectt INC

Validation Engineer

New York, NY · On-site

New York Summary: Seeking a Validation Engineer with strong experience in analytical instruments and CSA/CSV to support GMP operations in biologics / cell & gene therapy environments. Key ...

Pinnaql

Validation Engineer

Atlanta, GA · On-site

Validation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions ... FAT, SAT, CSV, equipment integration, and startup. * Drive process design for new equipment and ...

Pinnaql

Validation Engineer

Cincinnati, OH

Validation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions ... FAT, SAT, CSV, equipment integration, and startup. * Drive process design for new equipment and ...

Intellectt INC

Senior Validation Engineer

Portland, OR · On-site

Senior Validation Engineer Location: Oregon Summary: Seeking a Senior Validation Engineer with ... Support CSV (ValGenesis preferred) * Manage full lifecycle of QC equipment (qualification to ...

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How much do csv validation engineer jobs pay per hour?

As of Jul 20, 2026, the average hourly pay for csv validation engineer in the United States is $52.00, according to ZipRecruiter salary data. Most workers in this role earn between $39.42 and $63.22 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 are Csv Validation Engineers?

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.

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Csv Validation Engineer jobs near you
Infographic showing various Csv Validation Engineer job openings in the United States as of July 2026, with employment types broken down into 2% As Needed, 85% Full Time, 3% Part Time, 1% Temporary, and 9% Contract. Highlights an 84% Physical, 3% Hybrid, and 13% Remote job distribution, with an average salary of $108,152 per year, or $52 per hour.
Sr. CSV Validation Engineer

Sr. CSV Validation Engineer

Genezen

Lexington, MA

$115K - $140K/yr

Other

Posted 3 days ago

Job description

JOB SUMMARY

The incumbent is responsible for leading computerized systems validation projects. This includes qualification of GxP computerized systems for both laboratory and manufacturing based equipment as well as GMP software applications. Key deliverables are preparation of relevant documentation to meet regulatory requirements for new and existing products (Validation Plans, User Requirements Specifications (URS), Risk Assessments, IQ/OQ/PQ protocols and Traceability Matrices). Collaborate with cross functional teams, ensure compliance with regulatory requirements, and drive bestinclass validation practices that support our Quality Management System and operational excellence. 

ESSENTIAL JOB FUNCTIONS

  • Lead Protocol generation, oversee execution, data analysis, report generation and approval of qualification activities for GMP software applications
  • Review and approve qualification documentation on behalf of the validation function
  • Evaluate, audit, and guide software validation activities to ensure compliance with FDA, ISO, Data Integrity guidance, and internal standards
  • Support investigations into protocol nonconformances and site deviations
  • Serve as initiator and owner of validation related change controls and corrective and preventative actions
  • Author standard operating procedures related to CSV validation practices
  • Support the execution and generation of formal risk assessments
  • Enhance CSV validation programs
  • Analyze validation data, identify gaps, and support investigations and corrective actions
  • Represent CSV during audits and regulatory inspections

SPECIAL WORK REQUIREMENTS

  • Fully onsite position
  • Strong communication skills
  • Familiarity with Microsoft Office, Excel, and Visio
  • Ability to work well with diverse groups in a matrix-style, growing, safety focused organization
  • Ability to manage multiple activities
  • The ability to communicate with fellow project team members
  • Criminal background check required
  • Other duties as assigned

EDUCATION/CERTIFCATIONS/LICENSES

A minimum of a Bachelor's degree in Engineering, Computer
Science or related discipline

Desired

ON-THE-JOB EXPERIENCE

7+ years of Computer System Validation experience  

Desired

KNOWLEDGE, SKILLS AND EXPERIENCE

In depth CSV experiences including as a Validation lead

Essential

The ability to communicate with employees of all experience levels from Genezen and other contract firms

Essential

The ability to report on project activity in a clear and concise manner

Essential

The ability to communicate with fellow project team members

Essential

Understanding of cGMP regulations

Essential

Technical writing ability

Essential

Familiarity with Microsoft Office

Essential

Ability to work well with diverse groups in a matrix-style, growing, safety focused organization

Essential

Ability to manage multiple activities with challenging timelines

Essential

In depth knowledge of 21 CFR Part 11, EU GMP Annex 11 and GAMP5 computerized system

Essential

Pay Range:
The annual salary range for this position based upon level hired is: $115,000 - $140,000

Work Environment

  • Regularly sit for extended periods of time

Movement

  • Frequently required to stand; sit; use hands to finger, handle, or feel; reach with hands and arms 
  • Occasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawl

Lifting

  • Frequently lift and/or move up to 10 pounds
  • Rarely lift and/or move up to 25 pounds

Vision

  • Frequently utilize close vision and the ability to adjust focus

Communication

  • Frequently required to communicate by talking, hearing, using telephone and e-mail      

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