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Computer System Validation Engineer Jobs in New York

Katalyst CRO

CSV Engineer

Somerset, NJ · On-site

Required : • Bachelor's degree in Computer Science, Engineering, Life Sciences, or related discipline • 5+ years of Computer System Validation (CSV) experience in pharmaceutical or life sciences ...

Katalyst CRO

CSV Engineer

Somerset, NJ · On-site

Required : • Bachelor's degree in Computer Science, Engineering, Life Sciences, or related discipline • 5+ years of Computer System Validation (CSV) experience in pharmaceutical or life sciences ...

Jobtailor

Director, Business System Validation

Rahway, NJ · On-site

$180 - $230/hr

Bachelor's Degree in computer science, math or science with a minimum of 10 year's experience working in relevant field for associated (System Validation, Quality Assurance, Testing Lead or related ...

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 ...

Actalent

Validation Engineer

Paramus, NJ

Validation Engineer This role focuses on developing and executing validation, cleaning, and ... CIP) systems, autoclaves, and heat sterilization to ensure they meet regulatory and internal ...

R3tek

Validation Engineer

Hillsborough, NJ · On-site

R3 Technology Inc. seeks Validation Engineer or it Hillsborough NJ office to gather requirements to develop product-level requirements and assist with high level systems view of product design.

Deloitte

System Test and Validation Lead

Jericho, NY · On-site +1

Bachelor's degree in business, information systems, computer science, engineering, or equivalent experience; 6+ years of experience in computer system validation in a life sciences environment ...

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Computer System Validation Engineer information

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

As of Aug 16, 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.

Are computer system validation engineers in demand?

Computer System Validation Engineers are in demand due to the increasing regulation of pharmaceutical, biotech, and medical device industries that require compliant validation of computer systems. They often need skills in validation protocols, GxP regulations, and validation tools, making their expertise valuable in ensuring quality and compliance in regulated environments.

What does a computer system validation engineer do?

A computer system validation engineer ensures that computer systems used in regulated industries, such as pharmaceuticals or biotech, meet required standards for quality and compliance. They develop validation protocols, execute testing, and document results to verify systems function correctly and consistently. This role often involves working with validation tools, regulatory guidelines, and maintaining detailed records to support audits and inspections.

What are the key skills and qualifications needed to thrive as a computer system validation engineer?

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.

Do computer system validation engineers make good money?

Computer System Validation Engineers typically earn competitive salaries that vary by experience, location, and industry. They often have specialized skills in validation protocols, regulatory compliance, and validation tools, which can contribute to higher earning potential. Overall, this role is considered well-compensated within the pharmaceutical, biotech, and healthcare sectors.

Is computer system validation a good field?

Computer System Validation (CSV) is a vital part of regulated industries like pharmaceuticals and biotech, ensuring that computer systems meet quality and compliance standards. It offers opportunities for roles such as validation engineers, often requiring knowledge of GxP regulations, validation protocols, and tools like audit trails. The field provides stable employment with potential for career growth, especially with certifications like GAMP or 21 CFR Part 11 knowledge.

What are popular job titles related to Computer System Validation Engineer jobs in New York?

For Computer System Validation Engineer jobs in New York, the most frequently searched job titles are:

What job categories do people searching Computer System Validation Engineer jobs in New York look for?

The top searched job categories for Computer System Validation Engineer jobs in New York are:

Computer System Validation Engineer jobs near you
Infographic showing various Computer System Validation Engineer job openings in New York as of August 2026, with employment types broken down into 1% As Needed, 81% Full Time, 15% Part Time, 1% Temporary, and 2% Contract. Highlights an 92% Physical, 2% Hybrid, and 6% Remote job distribution, with an average salary of $117,879 per year, or $56.7 per hour.

Computer System Validation (CSV) Engineer

Kashiv BioSciences, LLC

Piscataway, NJ

Full-time

Re-posted 15 days ago

Job description

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.

Apply