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Senior Computer System Validation Csv Jobs (NOW HIRING)

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 ...

Mirus Consulting Group

CSV Specialist

Gurabo, PR · On-site

... provides computer system validation and information technology consulting services to ... The CSV Specialist will be responsible for managing and executing all activities related to ...

Lonza

WI · On-site

$80 - $120/hr

As the Computer System Validation (CSV) Expert you will report directly to the local CSV manager and be the domain expert responsible for implementing Computer System Validations at our site in ...

New

Prophecy Technologies

R&D CSV Engineer

Wilmington, DE · On-site

This role is for a Computer System Validation (CSV) Engineer with strong R&D domain knowledge, focusing on ensuring GxP compliance for various systems. The engineer will be responsible for applying ...

Mirus Consulting Group

CSV Specialist

Gurabo, PR · On-site

... provides computer system validation and information technology consulting services to ... The CSV Specialist will be responsible for managing and executing all activities related to ...

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

As of Aug 20, 2026, the average hourly pay for senior computer system validation csv in the United States is $64.77, according to ZipRecruiter salary data. Most workers in this role earn between $51.68 and $73.56 per hour, depending on experience, location, and employer.

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.

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Senior Computer System Validation Csv jobs near you
Infographic showing various Senior Computer System Validation Csv job openings in the United States as of August 2026, with employment types broken down into 1% As Needed, 84% Full Time, 12% Part Time, and 3% Contract. Highlights an 92% Physical, 2% Hybrid, and 6% Remote job distribution, with an average salary of $134,726 per year, or $64.8 per hour.

CSV Consultant

ClinDCast LLC

Somerville, NJ • On-site

$45 - $50/hr

Full-time

Posted 15 days ago

Job description

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 strong experience validating enterprise applications while ensuring compliance with FDA and global regulatory standards.
Key Responsibilities:

  • Perform Computer System Validation (CSV) activities for SAP ERP, WMS, and enterprise applications.
  • Develop and execute validation documentation, including Validation Plans, Requirements, Test Protocols, Traceability Matrix, and Validation Summary Reports.
  • Validate AI-enabled systems, including Generative AI, Agentic AI, LLM-based applications, AI agents, and orchestration frameworks.
  • Ensure compliance with GAMP 5, CSA, 21 CFR Part 11, Annex 11, and GxP regulations.
  • Review and approve system testing, UAT scripts, design specifications, and validation deliverables.
  • Support audit and inspection readiness activities.
  • Collaborate with cross-functional and remote teams to deliver validation projects.
  • Provide validation guidance and support multiple projects simultaneously.
Required Skills:

  • 5+ years of Computer System Validation (CSV) experience in GxP-regulated environments.
  • Strong experience with SAP ERP (mandatory).
  • Experience validating Generative AI, Agentic AI, LLM-based applications, and AI governance.
  • Knowledge of GAMP 5, CSA, FDA regulations, 21 CFR Part 11, Annex 11, and risk-based validation.
  • Experience in the pharmaceutical, biotechnology, or medical device industry.
  • Excellent documentation, analytical, communication, and problem-solving skills.

Flexible work from home options available.

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About ClinDCast

Sourced by ZipRecruiter

ClinDCast is at the forefront of shaping the future of healthcare by partnering with globally recognized healthcare organizations and offering them innovative solutions and expert guidance. Our suite of services is designed to cater to a broad range of needs of healthcare organizations, including healthcare IT innovation, electronic health record (EHR) implementation & optimizations, data conversion, regulatory and quality reporting, enterprise data analytics, FHIR interoperability strategy, payer-to-payer data exchange, and application programming interface (API) strategy. With 15+ Years Of Healthcare IT Industry Experience, ClinDCast Is A Trusted Partner For Payers, Providers, And Lifesciences Organizations, Enabling Them To Deliver Exceptional Product And Solutions For Their Customers.

Industry

Health care and social assistance

Company size

11 - 50 Employees

Headquarters location

Wesley Chapel, FL, US

Social media

Twitter

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