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Senior Computer System Validation Csv Jobs (NOW HIRING)

Cognizant

Computer System Validation (CSV) Lead

Cognizant is seeking a Computer System Validation (CSV) Lead to lead validation and testing activities for regulated systems. The role involves ensuring compliance with industry standards and ...

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Intellectt INC

Senior Validation Engineer

Portland, OR · On-site

Seeking a Senior Validation Engineer with strong GMP experience to support QC equipment validation and Computer System Validation (CSV) activities. Key Responsibilities: * Author & execute URS, IQ/OQ ...

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Senior Computer System Validation Csv information

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

As of Jul 10, 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 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 key skills and qualifications needed to thrive as a Senior Computer System Validation (CSV) professional, and why are they important?

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 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.
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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 July 2026, with employment types broken down into 1% As Needed, 85% Full Time, 12% Part Time, and 2% Contract. Highlights an 82% Physical, 1% Hybrid, and 17% Remote job distribution, with an average salary of $134,726 per year, or $64.8 per hour.
Senior Computer System Validation (CSV) Consultant - Concord, NC (Onsite)

Senior Computer System Validation (CSV) Consultant - Concord, NC (Onsite)

Smart Caliber Technology

Concord, NC • On-site

Other

Re-posted 4 days ago

Job description

Job Title: Senior Computer System Validation (CSV) Consultant - Concord, NC (Onsite)

Location: Concord, NC (Onsite)
Duration: 12 Months
Visa: Open to All Work Authorisations
Experience: 4–6 Years (Strong Communication Skills Required)
Industry: Pharmaceutical / Life Sciences / Healthcare

Job Summary

We are seeking an experienced Senior Computer System Validation (CSV) Consultant to support validation and compliance initiatives for MES and other GMP-regulated systems within a pharmaceutical/life sciences environment. The ideal candidate will possess strong expertise in Computer System Validation (CSV), IT Governance, Regulatory Compliance, and Quality Systems, with hands-on experience validating manufacturing and enterprise applications in regulated environments.

The consultant will collaborate closely with Quality, Manufacturing, IT, Compliance, and Business stakeholders to ensure systems remain compliant with FDA regulations, GAMP5 guidelines, 21 CFR Part 11 requirements, and internal quality standards throughout the system lifecycle.

Key Responsibilities

  • Lead end-to-end Computer System Validation (CSV) activities for MES and other GMP-regulated systems.
  • Support validation and compliance efforts for systems and platforms including:
    • Manufacturing Execution Systems (MES)
    • SAP EWM (Extended Warehouse Management)
    • Tulip
    • Other GMP/GxP-regulated applications and manufacturing systems
  • Prepare, review, and execute validation documentation, including:
    • Validation Plans (VP)
    • User Requirement Specifications (URS)
    • Functional & Design Specifications (FS/DS)
    • Risk Assessments
    • IQ/OQ/PQ Protocols
    • Traceability Matrix
    • Validation Summary Reports (VSR)
    • SOPs and Work Instructions
  • Ensure compliance with:
    • FDA 21 CFR Part 11
    • GAMP5 Guidelines
    • GxP Requirements
    • Data Integrity Standards
    • IT Governance and Compliance Policies
  • Execute and document validation testing activities with appropriate evidence and traceability.
  • Collaborate with QA, Manufacturing, IT, Infrastructure, Automation, and third-party vendors during implementation and validation phases.
  • Participate in:
    • Change Control
    • Deviation Management
    • CAPA Activities
    • Periodic Reviews
    • Audit and Inspection Readiness
  • Support risk-based validation methodologies and system lifecycle management.
  • Ensure systems are maintained in a validated and compliant state.

Required Skills & Experience

  • 4–6 years of experience in Computer System Validation (CSV) within pharmaceutical, biotechnology, medical device, or regulated healthcare environments.
  • Strong experience validating MES and manufacturing systems.
  • Solid understanding of:
    • GAMP5
    • FDA 21 CFR Part 11
    • GxP Compliance
    • Data Integrity Principles
    • SDLC and Validation Methodologies
    • IT Governance and Compliance Frameworks
  • Experience authoring and executing CSV documentation and validation protocols.
  • Strong knowledge of:
    • Audit Readiness
    • Change Management
    • Deviations
    • CAPA Processes
  • Excellent communication, documentation, and stakeholder management skills.
  • Ability to work effectively with cross-functional and global teams.

Preferred Qualifications

  • Experience with Cloud/SaaS Validation in regulated environments.
  • Familiarity with Agile and Risk-Based Validation methodologies.
  • Exposure to manufacturing automation, digital transformation, and Industry 4.0 initiatives within life sciences.
  • Bachelor’s degree in Computer Science, Engineering, Life Sciences, or a related field.

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