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Computer System Validation Csv Jobs (NOW HIRING)

Techengpr

CSV C&Q Technical Lead

Carolina, PR · On-site

$120 - $180/hr

This position is ideal for a senior Computer System Validation (CSV) professional who enjoys leading technical teams, defining validation strategies, collaborating with automation and commissioning ...

PSC Biotech

LabWare Specialist

Thousand Oaks, CA · On-site

$85K - $115K/yr

Validation & CSV Support * Support Computer System Validation (CSV) activities for LabWare implementations and enhancements. * Author and/or contribute to validation deliverables. * Ensure full ...

RESILIENCE

CSV Engineer III

West Chester, OH · On-site

Hands-on experience with automation and computer system validation (CSV). * Working knowledge of GxP regulations and validation standards for computerized systems, including 21 CFR Part 11, GAMP 5, ...

PSC Biotech

LabWare Specialist

Ventura, CA · On-site

Validation & CSV Support * Support Computer System Validation (CSV) activities for LabWare implementations and enhancements. * Author and/or contribute to validation deliverables. * Ensure full ...

RESILIENCE

CSV Engineer III

West Chester, OH · On-site

Hands-on experience with automation and computer system validation (CSV). * Working knowledge of GxP regulations and validation standards for computerized systems, including 21 CFR Part 11, GAMP 5, ...

Resilience

CSV Engineer III

West Chester, OH · On-site

Hands-on experience with automation and computer system validation (CSV). * Working knowledge of GxP regulations and validation standards for computerized systems, including 21 CFR Part 11, GAMP 5, ...

PSC Biotech

CA · On-site

Validation & CSV Support Support Computer System Validation (CSV) activities for LabWare implementations and enhancements. Author and/or contribute to validation deliverables. Ensure full ...

Spruce Infotech

Validation Expert

Fort Worth, TX · On-site

Work with project management to build an integrated project plan inclusive of the required Computer System Validation (CSV) Lifecycle Deliverables, quality gates and summarization milestones.

Actalent

Validation Engineer

Baltimore, MD

Contribute subject matter expertise in Commissioning and Qualification and Computer Systems Validation (CSV), including software validation and related activities. * Utilize validation-specific ...

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

As of Aug 11, 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 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 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 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.

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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, 12% Part Time, and 3% Contract. Highlights an 92% Physical, 2% Hybrid, and 6% Remote job distribution, with an average salary of $107,747 per year, or $51.8 per hour.

CSV C&Q Technical Lead

Technical and Engineering Consulting

Carolina, PR • On-site

Full-time

Posted 12 days ago

Job description

About the Opportunity

Technical & Engineering Consulting LLC is seeking an experienced Automation / CSV C&Q Technical Lead to support one of the most important pharmaceutical capital projects in Puerto Rico.

This position is ideal for a senior Computer System Validation (CSV) professional who enjoys leading technical teams, defining validation strategies, collaborating with automation and commissioning teams, and ensuring regulatory compliance throughout the project lifecycle.

The selected consultant will serve as the primary CSV technical lead, supporting computerized systems and automation associated with manufacturing process equipment from design through commissioning, qualification, startup, and final handover.

What You'll Do

As the Automation / CSV C&Q Technical Lead, you will:

  • Lead the Computer System Validation (CSV) strategy for the project.
  • Define validation requirements and technical direction throughout the project lifecycle.
  • Partner with Process Engineering to ensure automation solutions meet business requirements.
  • Provide technical leadership during software development and testing activities.
  • Collaborate closely with Design Verification, CQV, Automation Engineering, Operations, Quality, and external vendors.
  • Develop and review:
    • Validation Plans
    • User Requirements
    • Functional Specifications
    • Design Specifications
    • Requirements Traceability Matrices (RTM)
    • Test Scripts
    • Validation Summary Reports
  • Lead execution of IQ, OQ, and PQ protocols for automation and computerized systems.
  • Support FAT and SAT activities.
  • Manage deviations, investigations, change controls, and validation documentation.
  • Develop CSV training plans and training matrices.
  • Monitor CSV milestones, schedules, and project deliverables.
  • Ensure compliance with GAMP 5, Data Integrity (ALCOA+), cGMP, and company quality procedures.
  • Support system turnover to Manufacturing and Operations.
Required Qualifications
  • Bachelor's Degree in Automation, Controls, Chemical Engineering, Electrical Engineering, Computer Science, or related discipline.
  • Significant experience in Computer System Validation (CSV) within pharmaceutical, biotechnology, or other FDA-regulated environments.
  • Experience leading CSV activities on capital projects.
  • Strong understanding of:
    • GAMP 5
    • 21 CFR Part 11
    • Data Integrity (ALCOA+)
    • cGMP requirements
  • Hands-on experience developing and executing:
    • IQ/OQ/PQ
    • Validation Plans
    • RTMs
    • Test Scripts
    • Validation Reports
  • Experience supporting automation platforms and computerized manufacturing systems.
  • Experience with technical change management and deviation management.
  • Excellent technical writing and documentation skills.
  • Strong communication and leadership abilities.
Preferred Qualifications

Experience with one or more of the following is highly desirable:

  • Large pharmaceutical capital projects
  • Automation Lead or CSV Technical Lead roles
  • Manufacturing Execution Systems (MES)
  • Batch reporting systems
  • Data Historians
  • Alarm Management
  • FAT/SAT execution
  • Lilly systems and quality procedures
  • Regulatory inspections and FDA audits
What We're Looking For

The ideal candidate is:

  • A technical leader who can influence cross-functional teams
  • Highly organized and detail-oriented
  • Comfortable working in a fast-paced capital project environment
  • Experienced coordinating with engineering firms, automation integrators, contractors, and quality organizations
  • Passionate about delivering compliant, high-quality validation documentation
Why Join Technical & Engineering Consulting?

At Technical & Engineering Consulting LLC, you'll have the opportunity to contribute to some of Puerto Rico's largest pharmaceutical manufacturing projects while working alongside industry-leading engineering and validation professionals.

We value technical excellence, integrity, collaboration, and long-term professional relationships.

Apply