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Computer System Validation Csv Jobs in New York (NOW HIRING)

CSV Quality Support Lead CSI Companies is seeking a CSV Quality Support Lead to lead and execute Computer System Validation (CSV) activities across the system lifecycle. This role requires expertise ...

Participate in computer systems and vendor audits for review of their validation (fit-for-purpose ... Minimum 7 years' experience Computerized System Validation (CSV) experience * Minimum 5 years ...

... Computer System Validation (CSV) activities. Required Skills & Tools: • Experience with CSV and commissioning activities. • Strong knowledge of deviation investigation and documentation. • ...

... Computer Systems Validation (CSV) • Deep understanding of FDA regulations, GxP requirements, and data integrity • Experience supporting FDA approval processes and regulatory submissions • ...

CSV Engineer Location: Raritan, NJ(Hybrid) Mandatory - Validation experience with ERP applications ... Computer System Validation (Based on the role selected) • Experience in FDA and/or Global ...

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 ...

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 ...

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 Csv information

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$32

$56

$82

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

As of Jul 27, 2026, the average hourly pay for computer system validation csv 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 the key skills and qualifications needed to thrive in the Computer System Validation Csv position, and why are they important?

To thrive as a Computer System Validation (CSV) professional, you need a solid understanding of computer science, regulatory compliance (such as FDA 21 CFR Part 11), and validation methodology, often supported by a degree in a scientific or technical field. Familiarity with documentation tools, validation protocols, and quality management systems, as well as certifications like PMP or Six Sigma, is highly beneficial. Strong attention to detail, problem-solving abilities, and effective communication skills enable effective cross-functional collaboration. Mastering these skills ensures accurate validation processes, regulatory compliance, and smooth project execution in highly regulated environments.

What is a Computer System Validation (CSV) job?

A Computer System Validation (CSV) job involves ensuring that computerized systems used in regulated industries, such as pharmaceuticals and medical devices, comply with industry standards and regulatory requirements (e.g., FDA 21 CFR Part 11, GxP). CSV professionals develop validation protocols, conduct testing, and document system performance to ensure data integrity, reliability, and compliance. Their role is critical in maintaining system quality and avoiding regulatory risks.

What are some typical challenges faced by Computer System Validation professionals and how are they addressed?

Computer System Validation (CSV) professionals often encounter challenges such as keeping up with evolving regulations, managing complex documentation requirements, and ensuring robust communication between IT, quality assurance, and business teams. Navigating system upgrades while maintaining compliance with strict regulatory standards requires careful planning and thorough risk assessment. Successful candidates address these challenges by staying current with industry guidance, utilizing validation templates and checklists, and fostering strong teamwork across various departments. Building collaborative relationships and maintaining meticulous records help ensure both audit readiness and smooth project completion.

What are the most commonly searched types of Computer System Validation Csv jobs in New York? The most popular types of Computer System Validation Csv jobs in New York are:
What are popular job titles related to Computer System Validation Csv jobs in New York? For Computer System Validation Csv jobs in New York, the most frequently searched job titles are:
What cities in New York are hiring for Computer System Validation Csv jobs? Cities in New York with the most Computer System Validation Csv job openings:
Infographic showing various Computer System Validation Csv job openings in New York as of July 2026, with employment types broken down into 78% Full Time, and 22% Contract. Highlights an 100% In-person 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.