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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

Raritan, NJ · On-site

$120 - $180/hr

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

ClinDCast LLC

CSV Consultant

Raritan, 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 ...

Tempus, Inc.

Senior Quality Engineer

Manhattan, NY · On-site

$100 - $150/hr

## Senior Quality EngineerApplylocations: Chicago: Redwood City: New York City: Ambry Headquarterstime ... Lead computer system validation (CSV) activities of Tempus AI applications, software tools, and ...

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 ...

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 ...

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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:

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

Resourcesys

Piscataway, NJ • On-site

Other

Posted 9 days ago

Job description


Job Title:- Computer System Validation (CSV) Consultants
Location:- Piscataway, NJ/Chicago, IL (Onsite)
Duration:- Contract to hire
Job Description

Responsibilities

  • Plan, author, execute, and maintain CSV documentation including Validation Plans (VP), User Requirements Specifications (URS), Functional Specifications (FS), Design Specifications (DS), IQ/OQ/PQ protocols, Traceability Matrices, and Validation Summary Reports.
  • Perform CSV activities for laboratory instruments, engineering/manufacturing equipment, and enterprise applications.
  • Validate systems including LIMS, SAP, CMMS/calibration platforms, and other GxP-regulated applications.
  • Partner with system owners, Quality, IT, Laboratory, and Manufacturing teams to maintain systems in a validated state through change control and periodic reviews.
  • Conduct risk assessments and data-integrity assessments aligned with ALCOA+ principles.
  • Support audits, inspections, CAPAs, deviations, and remediation activitiesrelated to computerized systems.
  • Apply GAMP 5 and risk-based validation principles throughout the system lifecycle.
  • Support validation activities involvingCaliber LIMS, SAP QM/MM/PP, BMRAM or comparable CMMS/calibration systems where applicable.

Required Qualifications

  • 5+ years of Computer System Validation experience within a GxP-regulated environment.
  • Strong, demonstrable CSV experience specifically within Biotechnology/Biotech environments REQUIRED.
  • Hands-on experience authoring and executing IQ/OQ/PQ protocols.
  • Strong working knowledge of 21 CFR Part 11, EU Annex 11, GxP, GAMP 5, and risk-based validation.
  • Experience validating at least two of the following:
    • Laboratory instruments
    • Manufacturing/engineering equipment
    • LIMS
    • SAP
    • CMMS/calibration systems
  • Experience working cross-functionally withQuality, IT, Laboratory, Manufacturing, and technical SMEs.
  • Bachelor's degree in Life Sciences, Engineering, IT, or equivalent relevant life-sciences laboratory experience.
  • Ability and willingness to work onsite 5 days per week.
  • Candidates must be interested and eligible for a contract-to-hire opportunity.

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