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Freelance Computer System Validation Csv Jobs (NOW HIRING)

Mirus Consulting Group

CSV Specialist

Gurabo, PR

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

Moriah Engineering

PR · On-site

$90.10K - $118.60K/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 ...

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Mirus Consulting Group

CSV Specialist

Gurabo, PR

... 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 freelance computer system validation csv jobs pay per hour?

As of May 29, 2026, the average hourly pay for freelance computer system validation csv in the United States is $52.00, according to ZipRecruiter salary data. Most workers in this role earn between $39.42 and $63.22 per hour, depending on experience, location, and employer.

What are the key skills and qualifications needed to thrive as a Freelance Computer System Validation (CSV) specialist, and why are they important?

To thrive as a Freelance Computer System Validation (CSV) specialist, you need expertise in regulatory compliance (such as FDA 21 CFR Part 11), validation protocols, and risk-based validation methodologies, often supported by a degree in life sciences, engineering, or IT. Familiarity with industry-standard validation tools, software testing platforms, and knowledge of GxP systems as well as certifications like PMP or GAMP are commonly required. Strong project management, analytical thinking, and effective communication skills set top performers apart in client-facing freelance environments. These competencies are crucial for ensuring validated systems meet strict regulatory requirements while efficiently managing projects and client expectations.

What are some common challenges faced by freelance Computer System Validation (CSV) specialists, and how can they effectively overcome them?

Freelance CSV specialists often encounter challenges such as adapting to diverse client systems, staying updated with evolving regulatory requirements, and managing multiple projects simultaneously. To overcome these, it's important to maintain strong communication with client teams, invest in ongoing professional development, and utilize project management tools to keep workflows organized. Additionally, building a network with other CSV professionals can provide valuable support and industry insights.

What is a Freelance Computer System Validation (CSV) specialist?

A Freelance Computer System Validation (CSV) specialist is an independent professional who ensures that computer systems used in regulated industries, such as pharmaceuticals or biotechnology, comply with industry standards and regulatory requirements. CSV specialists test and document that software and hardware systems function as intended, are reliable, and meet compliance guidelines like FDA 21 CFR Part 11 or EU Annex 11. As freelancers, they work on a contract basis, often supporting multiple clients, and may help design validation strategies, conduct risk assessments, and prepare necessary documentation for audits and inspections.
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Freelance Computer System Validation Csv jobs near you
Infographic showing various Freelance Computer System Validation Csv job openings in the United States as of May 2026, with employment types broken down into 1% As Needed, 95% Full Time, and 4% Contract. Highlights an 89% Physical, and 11% Remote job distribution, with an average salary of $108,152 per year, or $52 per hour.

Validation Specialist - QC Equipment (CSV Focus)

Technical and Engineering Consulting

Yauco, PR • On-site

Full-time

Posted 25 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

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