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Computer System Validation Csv Jobs (NOW HIRING)

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

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

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

PR · On-site

$90K - $118K/yr

The ideal candidate will have extensive expertise in validation and compliance, computer system validation (CSV), and familiarity with DeltaV, Aveeva PI. A background in the biotechnology industry is ...

CSV Lead

Carolina, PR

$90K - $118K/yr

The ideal candidate will have extensive expertise in validation and compliance, computer system validation (CSV), and familiarity with DeltaV, Aveeva PI. A background in the biotechnology industry is ...

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

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Computer System Validation CSV information

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

As of Jun 26, 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 the Computer System Validation Csv position, and why are they important?

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) job?

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 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.

What cities are hiring for Computer System Validation Csv jobs? Cities with the most Computer System Validation Csv job openings:
What are the most commonly searched types of Computer System Validation Csv jobs? The most popular types of Computer System Validation Csv jobs are:
What states have the most Computer System Validation Csv jobs? States with the most job openings for Computer System Validation Csv jobs include:
Infographic showing various Computer System Validation Csv job openings in the United States as of June 2026, with employment types broken down into 99% Full Time, and 1% Nights. Highlights an 93% Physical, 2% Hybrid, and 5% Remote job distribution, with an average salary of $107,747 per year, or $51.8 per hour.

Validation Specialist - QC Equipment (CSV Focus)

Technical and Engineering Consulting

Yauco, PR

Other

Posted 24 days ago


Job description

Position Overview

Technical & Engineering Consulting is seeking a Validation Specialist with strong Computer System Validation (CSV) experience to support Quality Control (QC) laboratory equipment qualification in a regulated pharmaceutical environment.

This role will focus on analytical laboratory systems, including FTIR Spectrophotometers (Identification testing) and Endotoxin testing systems (e.g., Nebula), ensuring compliance with cGMP, Data Integrity, and regulatory expectations.

Key Responsibilities
  • Execute qualification and validation activities for QC laboratory equipment and computerized systems
  • Develop and/or support protocol generation (IQ, OQ, PQ)
  • Perform protocol execution and discrepancy resolution
  • Support review and approval of validation documentation
  • Ensure compliance with CSV lifecycle requirements (GAMP 5 approach preferred)
  • Utilize electronic document management systems (EDMS) for documentation control
  • Support data integrity assessments and audit readiness
  • Collaborate with QC, QA, IT, and Validation teams
  • Ensure alignment with QC lab requirements and regulatory standards (FDA, cGMP)
Required Qualifications
  • Bachelor's degree in Microbiology, Chemistry, Engineering, or related field
  • 3-5 years of experience in validation within regulated environments (Pharma / Biotech / Medical Devices)
  • Hands-on experience with QC laboratory equipment qualification
  • Strong knowledge of Computer System Validation (CSV)
  • Experience with analytical instrumentation (e.g., FTIR, endotoxin systems)
  • Familiarity with:
    • cGMP regulations
    • Data Integrity (ALCOA+)
    • Validation lifecycle documentation
Preferred Qualifications
  • Experience with FTIR Spectrophotometer (ID testing)
  • Experience with Endotoxin testing systems (Nebula or similar)
  • Knowledge of LIMS, Empower, or other lab systems
  • Experience with TrackWise, Kneat, or similar validation systems
  • Familiarity with GAMP 5 methodology
Key Skills
  • Strong technical writing and documentation skills
  • Attention to detail and compliance mindset
  • Ability to work cross-functionally in fast-paced environments
  • Problem-solving and analytical thinking