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Csv Validation Engineer Jobs (NOW HIRING)

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 ...

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 ...

Arthur Lawrence

Be Seen First

Validation Engineer / CQV

Boston, MA · On-site

$40 - $45/hr

Job Summary We are seeking a Validation Engineer to support validation, qualification, and ... Support Computerized System Validation (CSV) activities * Assist in validation of autoclaves, CIP ...

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 ...

Avantor, Inc.

Quality Validation Engineer

Devens, MA · On-site

Own and execute the CSV lifecycle for Quality and GxP computerized systems (e.g., eQMS, EDMS ... by Operations/Engineering. * Serve as site Validation/CSV subject matter expert for internal ...

Avantor Inc.

Quality Validation Engineer

Devens, MA · Hybrid

Own and execute the CSV lifecycle for Quality and GxP computerized systems (e.g., eQMS, EDMS ... by Operations/Engineering. * Serve as site Validation/CSV subject matter expert for internal ...

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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

Computer System Validation (CSV) Engineer

Kashiv Biosciences LLC

Piscataway, NJ • On-site

Full-time

Posted 27 days ago

Job description

Job Type
Full-time
Description
Position Type: Full-time Employee (FTE)
Location: Piscataway, NJ (onsite - physical presence required)
Reports To: Sr. Director of IT
Work Authorization: Must be authorized to work in the U.S. without sponsorship, now or in the future
Position Summary
We are seeking an experienced CSV Engineer to support validation activities across a broad portfolio of regulated systems, including laboratory instrumentation, engineering and manufacturing equipment, and enterprise platforms. This role serves as a liaison across Quality, IT, Laboratory, and Manufacturing functions, ensuring systems are validated and maintained in compliance with 21 CFR Part 11, GxP, and EMA requirements.
Essential Duties & Responsibilities
  • Plan, author, and execute validation deliverables (VP, URS, FS, DS, IQ/OQ/PQ, Traceability Matrix, Validation Summary Reports) across assigned systems
  • Support CSV activities across lab instruments (HPLC, GC, spectrophotometers, balances, etc.), engineering and manufacturing equipment, and enterprise systems including Caliber LIMS, SAP, and BMRAM
  • Partner with system owners, QA, and IT to maintain systems in a validated state through change control and periodic review
  • Execute risk assessments and data integrity assessments aligned with ALCOA+ principles
  • Support audits, inspections, CAPA investigations, and deviations related to computerized systems
  • Collaborating with senior validation leads and SMEs to drive consistent practices across sites

Requirements
Position Requirements and Qualifications
  • Bachelor's degree in Life Sciences, Engineering, or IT; OR equivalent laboratory experience in a life sciences environment
  • Minimum 5 years of CSV experience in a GxP-regulated environment
  • Working knowledge of 21 CFR Part 11, EU Annex 11, and EMA guidance
  • Hands-on experience authoring and executing IQ/OQ/PQ protocols
  • Experience validating at least two of: laboratory instruments, engineering/manufacturing equipment, LIMS, SAP, or CMMS/calibration platforms (e.g., BMRAM)

Experience:
  • Minimum 5 years of CSV experience in a GxP-regulated environment
  • Working knowledge of 21 CFR Part 11, EU Annex 11, and EMA guidance
  • Hands-on experience authoring and executing IQ/OQ/PQ protocols
  • Experience validating at least two of: laboratory instruments, engineering/manufacturing equipment, LIMS, SAP, or CMMS/calibration platforms (e.g., BMRAM)

Specialized Knowledge and Skills:
  • Familiarity with GAMP 5 principles and risk-based validation
  • Exposure to Caliber LIMS
  • Exposure to SAP (QM, MM, PP) in a GxP context
  • Experience with BMRAM or equivalent CMMS/calibration systems
  • Prior experience acting as a liaison across IT, Quality, Lab, and Manufacturing teams

Work Environment & Physical Demands:
  • This is an on-site position
  • Must be able to work extended hours or weekend hours, as may be required.

Noise:
  • No extraordinary noise levels.

Standing/Lifting:
  • Very unlikely, but can be able to lift at least 20 lbs.

Visual:
  • No extraordinary requirements.

Stress:
  • High-paced demanding environment to meet ambitious project goals.

Travel:
  • Moderate domestic travel may be required.

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