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Csv Validation Engineer Jobs (NOW HIRING)

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 ...

Intellectt INC

CSV Engineer

Social Circle, GA · On-site

Longterm Job Summary The CSV Engineer supports validation activities for computerized systems used in pharmaceutical/biopharmaceutical manufacturing. The role focuses on ensuring systems, equipment ...

supremesoft

CSV Validation QC Engineer

Jersey City, NJ · On-site

Mandatory Skills 7+ years of Lab Systems (& lab instrumentation) validation experience is required; with 7+ years of other CSV experience (with extensive experience authoring requirement specs, test ...

Intellectt INC

Validation Engineer

Boston, MA · On-site

Validation Engineer Location: Boston, MA Overview This engagement supports a large-scale Quality ... CSV / Part 11 exposure * Experience with high-volume documentation remediation Thanks & Regards ...

supremesoft

CSV Validation QC Engineer

Jersey City, NJ · On-site

Mandatory Skills • 7+ years of Lab Systems (& lab instrumentation) validation experience is required; with 7+ years of other CSV experience (with extensive experience authoring requirement specs ...

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Csv Validation Engineer information

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How much do csv validation engineer jobs pay per hour?

As of Jul 22, 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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What cities are hiring for Csv Validation Engineer jobs? Cities with the most Csv Validation Engineer job openings:
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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, 84% Full Time, 3% Part Time, 1% Temporary, and 10% Contract. Highlights an 83% Physical, 3% Hybrid, and 14% Remote job distribution, with an average salary of $108,152 per year, or $52 per hour.

Validation Engineer

Stark Pharma Solutions Inc

Rochester, NY • On-site

Contractor

Posted 2 days ago

New

Job description

Hi,

My name is Sravani Dasari from Stark Pharma Solutions Inc. We are hiring talent for our client and are currently working on a Validation Engineer position. Please send me your updated resume if you have relevant experience and are interested in this opportunity. The detailed job description is as follows.

Job Title: Validation Engineer
Location: Rochester, NY
Duration: Long Term

Position Overview

We are seeking a motivated and detail-oriented Validation Engineer to support validation activities within a GMP-regulated pharmaceutical, biotechnology, or medical device manufacturing environment. This role will be responsible for equipment qualification, process validation, cleaning validation, utility validation, and computerized system validation while ensuring compliance with FDA regulations, cGMP, GAMP 5, and industry standards. The ideal candidate will possess strong technical documentation skills and collaborate effectively with cross-functional teams to support manufacturing and quality operations.

Key Responsibilities

  • Execute Equipment Qualification activities including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for manufacturing and laboratory equipment.
  • Develop, review, execute, and maintain validation protocols, test scripts, and final validation reports.
  • Support Process Validation, Cleaning Validation, Utility Validation, and Computer System Validation (CSV) activities.
  • Perform risk assessments using FMEA and support validation lifecycle management.
  • Ensure validation documentation complies with FDA, cGMP, GAMP 5, 21 CFR Part 11, and company quality standards.
  • Investigate validation deviations, support CAPA implementation, and perform root cause analysis.
  • Collaborate with Engineering, Manufacturing, Quality Assurance, Quality Control, and Regulatory Affairs teams to execute validation projects.
  • Review engineering documentation including URS, FS, DS, SOPs, P&IDs, and equipment specifications.
  • Support equipment commissioning, startup, qualification, and process improvement initiatives.
  • Maintain Validation Master Plans (VMP), validation schedules, and project documentation.
  • Participate in internal audits, customer audits, and regulatory inspections.
  • Identify opportunities to improve validation processes, documentation, and compliance activities.

Required Qualifications

  • Bachelor's Degree in Mechanical Engineering, Chemical Engineering, Biomedical Engineering, Biotechnology, Pharmaceutical Engineering, or a related engineering discipline.
  • 2+ years of validation experience within the pharmaceutical, biotechnology, or medical device industry.
  • Hands-on experience with Equipment Qualification (IQ/OQ/PQ), Process Validation, Cleaning Validation, Utility Validation, or Computer System Validation (CSV).
  • Strong understanding of FDA regulations, cGMP, GAMP 5, 21 CFR Part 11, and data integrity requirements.
  • Experience developing, executing, and reviewing validation protocols and reports.
  • Familiarity with deviation investigations, CAPA, change control, and risk assessment methodologies.
  • Experience working in GMP-regulated manufacturing environments.
  • Strong technical writing, analytical, and problem-solving skills.
  • Excellent communication and cross-functional collaboration abilities.
  • Experience with validation management systems such as TrackWise, Kneat, Veeva, DeltaV, SCADA, PLC, or similar platforms is preferred.
  • Knowledge of Lean Manufacturing, continuous improvement, and commissioning & qualification (CQV) practices is an added advantage.

I am actively connecting with professionals for current and upcoming opportunities. If you are open to exploring new roles or would like to stay informed about relevant positions, please send me your updated resume along with the best number and time to reach you.

Please follow Stark Pharma Solutions on LinkedIn for the latest job updates:
https://www.linkedin.com/company/99455976/