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Csv Validation Engineer Jobs (NOW HIRING)

Genezen

Senior CSV Validation Engineer

Lexington, MA · On-site

The Senior CSV Validation Engineer will lead computerized systems validation projects, ensuring compliance with regulatory requirements and driving best practices in validation. Responsibilities ...

Genezen

Sr. CSV Validation Engineer

Lexington, MA · On-site

The Sr. CSV Validation Engineer will lead computerized systems validation projects, ensuring compliance with regulatory requirements and driving best-in-class validation practices. Responsibilities ...

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

Holly Springs, NC

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

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 ...

Zifo

CSV Validation Analyst

Emeryville, CA

Lead or support validation of computerized systems & laboratory instruments, including installation ... We look for Science - Biotechnology, Pharmaceutical Technology, Biomedical Engineering ...

Intellectt INC

Validation Engineer

Charlotte, NC · On-site

Validation Engineer Location: North Carolina Job Summary: The Validation Engineer will be ... Experience in CSV and SDLC * Knowledge of QMS and risk management * Familiarity with Lean/Six Sigma ...

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How much do csv validation engineer jobs pay per hour?

As of Jun 29, 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
Senior CSV Validation Engineer

Senior CSV Validation Engineer

Genezen

Lexington, MA • On-site

Full-time

Posted 7 days ago

Job description

Job Summary:
Genezen is a company focused on gene therapy, providing process development and GMP viral vectors for clinical trials. The Senior CSV Validation Engineer will lead computerized systems validation projects, ensuring compliance with regulatory requirements and driving best practices in validation.
Responsibilities:
• 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
Qualifications:
Required:
• A minimum of a Bachelor’s degree in Engineering, Computer Science or related discipline
• 7+ years of Computer System Validation experience
• In depth CSV experiences including as a Validation lead
• The ability to communicate with employees of all experience levels from Genezen and other contract firms
• The ability to report on project activity in a clear and concise manner
• Understanding of cGMP regulations
• Technical writing ability
• Familiarity with Microsoft Office
• Ability to work well with diverse groups in a matrix-style, growing, safety focused organization
• Ability to manage multiple activities with challenging timelines
• In depth knowledge of 21 CFR Part 11, EU GMP Annex 11 and GAMP5 computerized system
• 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
Company:
Genezen offers contract process development, GMP viral vector production, transduced cell manufacturing, and testing services. Founded in 2014, the company is headquartered in Indianapolis, USA, with a team of 201-500 employees. The company is currently Growth Stage.

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