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Computer System Validation Csv Jobs in New Jersey

ClinDCast, LLC

CSV Consultant

Raritan, NJ · On-site

We are seeking an experienced CSV Consultant with expertise in Computer System Validation (CSV) , SAP ERP , and Generative AI/Agentic AI in a GxP-regulated environment . The ideal candidate will have ...

ClinDCast LLC

CSV Consultant

Somerville, NJ · On-site

$45 - $50/hr

Perform Computer System Validation (CSV) activities for SAP ERP, WMS, and enterprise applications. * Develop and execute validation documentation, including Validation Plans, Requirements, Test ...

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 ...

HPTech Inc.

Validation Lead

Raritan, NJ · On-site

Role - Validation Lead Location - Raritan, NJ (Hybrid) W2/C2C Job Details: 5+ years of Computer System Validation (CSV) experience in GxP-regulated environments, with hands-on experience in retro ...

Incorporan Inc

Validation Lead ( Need )

Raritan, NJ · On-site

Computer System Validation (CSV) experience in GxP -regulated environments, with hands-on experience in retro-validation activities and 21 CFR remediation projects with knowledge of CSA, GAMP 5, 21 ...

New

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 ...

CYNET SYSTEMS

CSV Consultant

Raritan, NJ · On-site

$48 - $53/hr

Pay Range: $48hr - $53hr Requirement/Must Have: 5+ years of Computer System Validation (CSV) experience in GxP-regulated environments, with hands-on validation and deployment of SAP ERP, WMS, and ...

CYNET SYSTEMS

CSV Consultant

Raritan, NJ · On-site

$48 - $53/hr

Pay Range: $48hr - $53hr Requirement/Must Have: * 5+ years of Computer System Validation (CSV) experience in GxP-regulated environments, with hands-on validation and deployment of SAP ERP, WMS, and ...

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Computer System Validation Csv information

What are the key skills and qualifications needed to thrive in computer system validation CSV?

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?

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 CSV 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 Jersey?

The most popular types of Computer System Validation Csv jobs in New Jersey are:

What are popular job titles related to Computer System Validation Csv jobs in New Jersey?

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

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The top searched job categories for Computer System Validation Csv jobs in New Jersey are:

Computer System Validation Csv jobs near you
Infographic showing various Computer System Validation Csv job openings in New Jersey as of August 2026, with employment types broken down into 100% Full Time. Highlights an 100% In-person job distribution.

Computer System Validation (CSV) Engineer

Kashiv Biosciences LLC

Piscataway, NJ • On-site

Full-time

Re-posted 11 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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