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Computer System Validation Csv Pharmaceutical Jobs

Moriah Engineering

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 ...

JC Automation Corp

PR · On-site

$70K - $92K/yr

Minimum 4 years of progressive, hands-on experience in Computer System Validation (CSV) or Automation Quality within the pharmaceutical or biotechnology manufacturing industry. * Proven track record ...

Catalent

Computer Systems Engineer

Kansas City, MO · On-site

... System Validation (CSV). • Acts as a Subject Matter Expert (SME) for Computer System Validation (CSV). • Assists and manages laboratory system contractors as required. • Reviews and approves ...

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

As of Jun 9, 2026, the average hourly pay for computer system validation csv pharmaceutical in the United States is $54.32, according to ZipRecruiter salary data. Most workers in this role earn between $41.83 and $64.42 per hour, depending on experience, location, and employer.

What is the difference between Computer System Validation Csv Pharmaceutical vs Quality Assurance Specialist?

AspectComputer System Validation Csv PharmaceuticalQuality Assurance Specialist
CertificationsGxP, 21 CFR Part 11, Validation certificationsGxP, ISO, QA certifications
Work EnvironmentPharmaceutical manufacturing, regulated labsQuality departments across industries, including pharma
Employer & IndustryPharmaceutical companies, biotech firmsPharma, biotech, healthcare organizations
Primary FocusEnsuring computer systems meet validation and compliance standardsMaintaining quality standards and process improvements

Computer System Validation Csv Pharmaceutical specialists focus on validating computer systems to ensure compliance with industry regulations, while Quality Assurance Specialists oversee overall quality processes. Both roles require GxP knowledge and are vital in pharmaceutical environments, but their core responsibilities differ in scope and focus.

What are some common challenges faced by Computer System Validation (CSV) professionals in the pharmaceutical industry?

CSV professionals in the pharmaceutical industry often encounter challenges such as keeping up with evolving regulatory requirements, managing documentation for audits, and ensuring thorough validation of complex systems within tight project timelines. Collaboration with cross-functional teams, such as IT, quality assurance, and manufacturing, is essential to address technical and compliance issues. Additionally, balancing the need for robust validation with operational efficiency requires strong communication and project management skills.

What are the key skills and qualifications needed to thrive as a Computer System Validation (CSV) professional in the pharmaceutical industry, and why are they important?

To thrive as a Computer System Validation (CSV) professional in pharmaceuticals, you need a strong background in life sciences or engineering, knowledge of regulatory standards (such as FDA 21 CFR Part 11), and experience with validation protocols. Familiarity with validation lifecycle management tools, quality management systems (QMS), and industry guidelines like GAMP 5 is typically required, along with certifications such as ISPE or PMP being advantageous. Outstanding attention to detail, analytical thinking, and strong communication skills help ensure compliance and effective coordination with cross-functional teams. These competencies are vital for maintaining regulatory compliance, data integrity, and patient safety in pharmaceutical operations.

What is Computer System Validation (CSV) in the pharmaceutical industry?

Computer System Validation (CSV) in the pharmaceutical industry is a process used to ensure that computerized systems used in drug manufacturing and related processes work as intended and comply with regulatory standards, such as FDA 21 CFR Part 11. CSV involves planning, testing, documenting, and maintaining systems to guarantee the accuracy, reliability, and integrity of data. This is critical for patient safety and product quality, as well as for meeting legal and regulatory requirements. The process typically includes risk assessment, validation planning, protocol execution, and ongoing monitoring of system performance.
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Computer System Validation Csv Pharmaceutical jobs near you
Infographic showing various Computer System Validation Csv Pharmaceutical job openings in the United States as of May 2026, with employment types broken down into 67% Full Time, and 33% Contract. Highlights an 100% In-person job distribution, with an average salary of $112,983 per year, or $54.3 per hour.

CSV Lead

Moriah Engineering

Carolina, PR

$90K - $118K/yr

Contractor

Posted 13 days ago

Job description

CSV Leadto oversee the validation of major capital automation projects. 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 preferred.
Key Responsibilities:
  • Lead validation activities for major capital automation projects, ensuring compliance with industry regulations and best practices.
  • Assure the development of the validation protocols, includingInstallation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
  • Ensure adherence toGxP guidelinessuch asGood Manufacturing Practice (GMP), Good Laboratory Practice (GLP), and Good Clinical Practice (GCP).
  • Maintain compliance with regulatory standards, includingFDA 21 CFR Part 11 and ISO 9001.
  • OverseeComputer System Validation (CSV)processes, including risk-based validation, system integration, interface testing, and data integrity assessments.
  • Collaborate with cross-functional teams to validate automation systems, includingSCADA and Aveeva Pi.
  • Prepare and maintain validation documentation, including protocols, reports, traceability matrices, and deviation records.

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