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Senior Computer System Validation Csv Jobs in New York

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 ...

Cynet Systems

Validation Lead

Raritan, NJ · On-site

$50 - $55/hr

Experience leading or advising junior and senior resources. * Specific experience in the ... Strong Computer System Validation (CSV) expertise, especially within acquisition, divestiture, and ...

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 ...

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

Validation Lead

Raritan, NJ · On-site

$50 - $55/hr

Experience leading or advising junior and senior resources. * Specific experience in the ... Strong Computer System Validation (CSV) expertise, especially within acquisition, divestiture, and ...

CYNET SYSTEMS

Validation Lead

Raritan, NJ · On-site

$50 - $55/hr

Experience leading or advising junior and senior resources. Specific experience in the ... Strong Computer System Validation (CSV) expertise, especially within acquisition, divestiture, and ...

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Senior Computer System Validation Csv information

What is a senior computer system validation (CSV) specialist?

A Senior Computer System Validation (CSV) specialist is an experienced professional responsible for ensuring that computer systems used in regulated industries—such as pharmaceuticals, biotechnology, or medical devices—meet compliance standards. This involves planning, executing, and documenting validation activities to demonstrate that systems consistently perform according to predefined specifications and regulatory requirements. Senior CSV specialists often lead validation projects, manage teams, and interact with regulatory auditors, making sure that systems are reliable, secure, and compliant with guidelines like FDA 21 CFR Part 11 and GxP. Their expertise helps organizations avoid compliance issues, data integrity problems, and costly system failures.

What are the key skills and qualifications needed to thrive as a senior computer system validation (CSV) professional?

To excel as a Senior Computer System Validation (CSV) professional, you need deep knowledge of regulatory compliance (such as FDA 21 CFR Part 11), validation lifecycle methodologies, and a background in computer science, engineering, or life sciences. Familiarity with validation management tools, risk assessment software, and quality management systems (QMS) is typically required, along with certifications like GAMP or Six Sigma being highly valued. Outstanding analytical skills, attention to detail, and strong communication abilities set high performers apart in this role. These competencies ensure validated systems meet regulatory requirements, maintain data integrity, and support quality operations in regulated industries.

What are some common challenges senior computer system validation (CSV) professionals face when working on large-scale projects?

Senior CSV professionals often encounter challenges such as coordinating validation activities across multiple departments, managing evolving regulatory requirements, and ensuring thorough documentation throughout the project lifecycle. They also need to balance project timelines with the need for comprehensive testing and risk assessments. Effective communication and collaboration with IT, QA, and business stakeholders are essential to address issues proactively and ensure compliance in complex, regulated environments.

What is the difference between Senior Computer System Validation Csv vs Computer System Validation Specialist?

AspectSenior Computer System Validation CsvComputer System Validation Specialist
CertificationsGxP, 21 CFR Part 11, CSV certificationsGxP, 21 CFR Part 11, CSV certifications
Work EnvironmentRegulated industries like pharma, biotech, medical devicesRegulated industries like pharma, biotech, medical devices
ResponsibilitiesLeading validation projects, ensuring compliance, mentoringExecuting validation activities, documentation, testing

While both roles require similar certifications and work in regulated environments, the Senior Computer System Validation Csv typically involves leading projects and overseeing compliance efforts, whereas the Computer System Validation Specialist focuses on executing validation tasks and documentation. The senior role often requires more experience and leadership responsibilities.

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 Senior Computer System Validation Csv jobs in New York?

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

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

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Cities in New York with the most Senior Computer System Validation Csv job openings:

Senior Computer System Validation Csv jobs near you

Computer System Validation (CSV) Engineer

Kashiv BioSciences, LLC

Piscataway, NJ • On-site

Full-time

Re-posted 22 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