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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 ...

ALLIANCE BIOTECH SOLUTIONS LLC

CSV Engineer

Raleigh, NC · On-site

Description The Senior Computer System Validation (CSV) Engineer is responsible for leading the validation of complex computerized systems, custom-developed applications, enterprise databases, data ...

Alliance Biotech Solutions LLC

CSV Engineer

Raleigh, NC · On-site

The Senior Computer System Validation (CSV) Engineer is responsible for leading the validation of complex computerized systems, custom-developed applications, enterprise databases, data platforms ...

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

As of Aug 12, 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 Specialist

Mirus Consulting Group

Gurabo, PR

Full-time

Re-posted 27 days ago

Job description

mîrus Consulting Group is a local company based in Humacao, Puerto Rico that provides computer system validation and information technology consulting services to pharmaceutical companies and other organizations across the Island and parts of the United States. Its services include the assessment and validation of automation equipment, network infrastructures and business processes, as well as the project management involved.
Position Summary:
The CSV Specialist will be responsible for managing and executing all activities related to Computer System Validation (CSV) throughout the full validation lifecycle, ensuring compliance with FDA, cGMP, 21 CFR Part 11, GAMP 5, and corporate standards. This position will support system implementations, upgrades, and periodic reviews across manufacturing and quality systems, with a strong focus on parenteral processes and regulated environments.
Key Responsibilities:
  • Develop, review, and execute CSV deliverables including Validation Plans, Risk Assessments, URS, FRS, IQ/OQ/PQ protocols, and Validation Summary Reports.
  • Ensure that computerized systems meet data integrity and regulatory compliance requirements.
  • Support system implementations, migrations, and upgrades, collaborating closely with IT, QA, and Manufacturing teams.
  • Participate in impact assessments, change control activities, and periodic system reviews.
  • Provide technical and compliance support during internal and external audits.
  • Maintain validation documentation in alignment with company quality systems and GAMP 5 guidance.
  • Support troubleshooting, deviation resolution, and CAPA implementation related to validated systems.
  • Promote continuous improvement and standardization of CSV practices across site operations.

Qualifications & Requirements:
  • Bachelor’s Degree in engineering
  • Minimum of 5 years of hands-on experience in Computer System Validation within the pharmaceutical or biotechnology industry.
  • Strong knowledge of CSV lifecycle methodology, 21 CFR Part 11, Annex 11, and GAMP 5.
  • Experience with parenteral operations or aseptic manufacturing environments preferred.
  • Excellent documentation, communication, and teamwork skills.
  • Fully bilingual (Spanish/English) preferred.
This Company is an equal employment opportunity employer. We adhere to a policy of making employment decisions without regard to race, color, religion, sex, sexual orientation, national origin, citizenship, age or disability. We assure you that your opportunity for employment with this Company depends solely on your qualifications.