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Computer System Validation Csv Jobs (NOW HIRING)

Inteldot

WI · On-site

$110 - $140/hr

Position Summary We are seeking an experienced Senior Computer System Validation (CSV) Engineer to support validation activities for GMP-regulated manufacturing and automation systems at client. The ...

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 ...

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 ...

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

As of Aug 31, 2026, the average hourly pay for computer system validation csv in the United States is $51.80, according to ZipRecruiter salary data. Most workers in this role earn between $38.94 and $64.42 per hour, depending on experience, location, and employer.

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 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 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.

Is computer system validation a good field?

Computer System Validation (CSV) is a specialized field within regulated industries like pharmaceuticals and biotech, focusing on ensuring software and systems meet compliance standards such as GxP. It offers opportunities for professionals with skills in quality assurance, validation protocols, and regulatory requirements, often requiring certifications like GAMP or 21 CFR Part 11 knowledge. The field provides stable employment with growth potential, especially as compliance regulations become more stringent.
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Computer System Validation Csv jobs near you
Infographic showing various 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, 13% Part Time, and 2% Contract. Highlights an 91% Physical, 2% Hybrid, and 7% Remote job distribution, with an average salary of $107,747 per year, or $51.8 per hour.

Computer System Validation (CSV) Engineer

Piscataway, NJ • On-site

Spadtek Solutions LLC
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Job description

Title : Computer System Validation (CSV) Engineer
Locations: Piscataway, NJ  | Chicago, IL 
Work Arrangement: Onsite
Employment Type: Full-Time
Experience: 5+ Years of CSV Experience in a GxP-Regulated Environment

Job Summary

We are seeking an experienced Computer System Validation (CSV) Engineer to support validation activities across a broad portfolio of regulated systems, including laboratory instrumentation, manufacturing and engineering equipment, and enterprise applications.

The CSV Engineer will work closely with Quality, IT, Laboratory, and Manufacturing teams to ensure computerized systems remain validated and compliant with GxP, 21 CFR Part 11, EU Annex 11, and applicable EMA requirements.

This is an onsite position reporting to the Sr. Director of IT. The successful candidate will have strong hands-on experience developing and executing CSV deliverables within a regulated life sciences environment.

Key Responsibilities
  • Plan, author, review, and execute CSV deliverables, including:
    • Validation Plans
    • User Requirements Specifications (URS)
    • Functional Specifications (FS)
    • Design Specifications (DS)
    • IQ/OQ/PQ protocols
    • Traceability Matrices
    • Validation Summary Reports (VSR)
  • Perform CSV activities for:
    • Laboratory instruments such as HPLC, spectrophotometers, and balances
    • Engineering and manufacturing equipment
    • LIMS platforms
    • SAP systems
    • CMMS/calibration systems such as BMRAM
  • Partner with System Owners, QA, IT, Laboratory, and Manufacturing teams to maintain systems in a validated state.
  • Support change control, periodic reviews, and validation lifecycle activities.
  • Conduct computerized system risk assessments and data integrity assessments in alignment with ALCOA+ principles.
  • Support audits, regulatory inspections, CAPA investigations, deviations, and compliance activities related to computerized systems.
  • Collaborate with senior validation leads and subject matter experts to establish and maintain consistent CSV practices across sites.
  • Ensure validation documentation meets applicable regulatory and quality standards.
Required Qualifications
  • Bachelor's degree in Life Sciences, Engineering, Information Technology, or a related field, or equivalent laboratory experience within a life sciences environment.
  • Minimum 5 years of Computer System Validation (CSV) experience in a GxP-regulated environment.
  • Strong working knowledge of:
    • 21 CFR Part 11
    • EU Annex 11
    • EMA guidance
    • GxP compliance requirements
  • Hands-on experience authoring and executing IQ/OQ/PQ protocols.
Preferred Qualifications
  • Familiarity with GAMP 5 principles.
  • Experience with risk-based validation methodologies.
  • Exposure to Caliber LIMS.
  • Experience with SAP QM, MM, or PP in a GxP environment.
  • Experience with BMRAM or comparable CMMS/calibration systems.
  • Experience working as a liaison between IT, Quality, Laboratory, and Manufacturing teams.
  • Strong understanding of computerized system lifecycle management and data integrity principles.

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