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Computer System Validation Engineer Jobs in New York

Intellectt INC

Validation Engineer

New York, NY · On-site

We have an urgent opening for a Validation Engineer position based in New York with one of our ... Perform CSA/CSV for lab systems (LIMS, Empower, Chromeleon) * Develop validation docs: URS, risk ...

Uncountable

Validation Engineer

New York, NY · On-site

$70K - $80K/yr

Review system requirements, design specifications, and user stories to ensure they are testable and ... Bachelor's degree in Engineering, Computer Science, Life Sciences, or a related field (or ...

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Computer System Validation Engineer information

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$56

$82

How much do computer system validation engineer jobs pay per hour?

As of Jul 26, 2026, the average hourly pay for computer system validation engineer in New York is $56.67, according to ZipRecruiter salary data. Most workers in this role earn between $42.60 and $70.48 per hour, depending on experience, location, and employer.

What are some common challenges faced by Computer System Validation Engineers in regulated industries?

Computer System Validation Engineers often encounter challenges such as keeping up with evolving regulatory requirements, managing documentation for multiple systems, and ensuring timely validation while coordinating with cross-functional teams. Balancing strict compliance with project deadlines can be demanding, especially when systems are complex or legacy infrastructure is involved. Additionally, effective communication with IT, QA, and business stakeholders is essential to address issues quickly and maintain validation standards.

What does a computer system validation engineer do?

A computer system validation engineer ensures that computer systems used in regulated industries meet required standards for quality, safety, and compliance. They develop validation protocols, perform testing, document results, and ensure systems function correctly according to regulatory guidelines such as FDA or GMP. This role often involves working with validation tools, risk assessments, and maintaining detailed documentation to support audits and inspections.

What are the key skills and qualifications needed to thrive as a Computer System Validation Engineer, and why are they important?

To thrive as a Computer System Validation Engineer, you need a solid background in computer science or engineering, knowledge of regulatory requirements (such as FDA or GxP), and experience in validation processes. Familiarity with validation tools, quality management systems, and documentation software is typically required, along with certifications like ISPE or ASQ being beneficial. Strong attention to detail, analytical thinking, and effective communication are essential soft skills for coordinating teams and ensuring compliance. These skills and qualities are crucial to ensure that computer systems meet regulatory standards, maintain data integrity, and support business operations in regulated industries.

What is the difference between Computer System Validation Engineer vs Quality Assurance Specialist?

AspectComputer System Validation EngineerQuality Assurance Specialist
CertificationsGAMP, GxP validation certificationsISO, Six Sigma, GMP certifications
Work EnvironmentPharmaceutical, biotech, medical device industriesManufacturing, software, healthcare sectors
Primary FocusValidating computer systems and software complianceEnsuring overall quality and process improvements

The Computer System Validation Engineer primarily focuses on validating computer systems to meet regulatory standards, ensuring software compliance in regulated industries. In contrast, the Quality Assurance Specialist oversees broader quality processes, including audits and process improvements. Both roles require knowledge of industry regulations but differ in scope and specific responsibilities.

What is the salary of SoC validation engineer?

The salary of a System on Chip (SoC) validation engineer typically ranges from $80,000 to $130,000 annually, depending on experience, location, and company size. Entry-level positions may start lower, while experienced engineers with specialized skills in hardware description languages and verification tools can earn higher salaries.

What is the salary of a CSV engineer?

The salary of a Computer System Validation (CSV) Engineer typically ranges from $70,000 to $120,000 annually, depending on experience, location, and certifications such as GxP or 21 CFR Part 11. Senior roles or those in high-cost-of-living areas may offer higher compensation, and knowledge of validation tools like MasterControl or ValGenesis can enhance earning potential.

Is computer system validation a good field?

Computer System Validation (CSV) is a vital field in regulated industries like pharmaceuticals and biotech, ensuring software and systems meet compliance standards such as 21 CFR Part 11. It offers stable job opportunities, requires knowledge of validation protocols, and often involves working with tools like GxP guidelines and validation documentation. The field is considered stable and growing due to ongoing regulatory requirements.
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Computer System Validation Engineer jobs near you
Infographic showing various Computer System Validation Engineer job openings in New York as of July 2026, with employment types broken down into 1% As Needed, 87% Full Time, 10% Part Time, and 2% Contract. Highlights an 82% Physical, 1% Hybrid, and 17% Remote job distribution, with an average salary of $117,879 per year, or $56.7 per hour.
Computer System Validation (CSV) Engineer

Computer System Validation (CSV) Engineer

Kashiv Biosciences LLC

Piscataway, NJ • On-site

Full-time

Posted 24 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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