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Senior Computer System Validation Csv Jobs (NOW HIRING)

Inteldot

WI · On-site

$110 - $140/hr

Position Summary We are seeking an experienced Senior Computer System Validation (CSV) Engineer to support validation activities for GMP-regulated manufacturing and automation systems at client. The ...

Validation & Engineering Group, Inc

PR

Computer System Validation (CSV) Specialist Project summary: * Validate and support the Electronic Batch Record / EVRS implementation so it meets 21 CFR Part 11, EU GMP Annex 11, GxP, and company ...

Compsciprep LLC

CSV Validation Consultant

Chicago, IL · On-site

Computer System Validation (CSV) / Validation Consultant - Life Sciences Location: Multiple Location Summary: We are looking for an experienced Computer System Validation (CSV) Consultant with strong ...

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

As of Aug 20, 2026, the average hourly pay for senior computer system validation csv in the United States is $64.77, according to ZipRecruiter salary data. Most workers in this role earn between $51.68 and $73.56 per hour, depending on experience, location, and employer.

What is a senior computer system validation (CSV) specialist?

A Senior Computer System Validation (CSV) specialist is an experienced professional responsible for ensuring that computer systems used in regulated industries—such as pharmaceuticals, biotechnology, or medical devices—meet compliance standards. This involves planning, executing, and documenting validation activities to demonstrate that systems consistently perform according to predefined specifications and regulatory requirements. Senior CSV specialists often lead validation projects, manage teams, and interact with regulatory auditors, making sure that systems are reliable, secure, and compliant with guidelines like FDA 21 CFR Part 11 and GxP. Their expertise helps organizations avoid compliance issues, data integrity problems, and costly system failures.

What are the key skills and qualifications needed to thrive as a senior computer system validation (CSV) professional?

To excel as a Senior Computer System Validation (CSV) professional, you need deep knowledge of regulatory compliance (such as FDA 21 CFR Part 11), validation lifecycle methodologies, and a background in computer science, engineering, or life sciences. Familiarity with validation management tools, risk assessment software, and quality management systems (QMS) is typically required, along with certifications like GAMP or Six Sigma being highly valued. Outstanding analytical skills, attention to detail, and strong communication abilities set high performers apart in this role. These competencies ensure validated systems meet regulatory requirements, maintain data integrity, and support quality operations in regulated industries.

What are some common challenges senior computer system validation (CSV) professionals face when working on large-scale projects?

Senior CSV professionals often encounter challenges such as coordinating validation activities across multiple departments, managing evolving regulatory requirements, and ensuring thorough documentation throughout the project lifecycle. They also need to balance project timelines with the need for comprehensive testing and risk assessments. Effective communication and collaboration with IT, QA, and business stakeholders are essential to address issues proactively and ensure compliance in complex, regulated environments.

What is the difference between Senior Computer System Validation Csv vs Computer System Validation Specialist?

AspectSenior Computer System Validation CsvComputer System Validation Specialist
CertificationsGxP, 21 CFR Part 11, CSV certificationsGxP, 21 CFR Part 11, CSV certifications
Work EnvironmentRegulated industries like pharma, biotech, medical devicesRegulated industries like pharma, biotech, medical devices
ResponsibilitiesLeading validation projects, ensuring compliance, mentoringExecuting validation activities, documentation, testing

While both roles require similar certifications and work in regulated environments, the Senior Computer System Validation Csv typically involves leading projects and overseeing compliance efforts, whereas the Computer System Validation Specialist focuses on executing validation tasks and documentation. The senior role often requires more experience and leadership responsibilities.

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Senior Computer System Validation Csv jobs near you
Infographic showing various Senior 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 $134,726 per year, or $64.8 per hour.

Senior Computer System Validation (CSV) Engineer - Consultant

Inteldot

WI • On-site

$110 - $140/hr

Other

Posted 10 days ago

Job description

Position Summary

We are seeking an experienced Senior Computer System Validation (CSV) Engineer to support validation activities for GMP-regulated manufacturing and automation systems at client. The ideal candidate will have extensive experience validating computerized systems within the pharmaceutical or biotechnology industry and hands-on experience with Emerson DeltaV automation systems. The successful candidate will work closely with Engineering, Automation, Manufacturing, Quality Assurance, and IT teams to ensure computerized systems are validated and maintained in compliance with FDA regulations, GAMP 5, and 21 CFR Part 11 requirements.

Location: Texas (Onsite)

Administrative shiftResponsibilities
  • Lead Computer System Validation (CSV) activities for GMP computerized systems.
  • Develop, review, and execute validation documentation, including Validation Plans, Risk Assessments, IQ/OQ/PQ protocols, Traceability Matrices, and Summary Reports.
  • Validate automation systems, including Emerson DeltaV DCS, SCADA, and supporting infrastructure.
  • Support commissioning and qualification activities for new and existing manufacturing systems.
  • Perform impact assessments, change control evaluations, and periodic reviews.
  • Ensure compliance with FDA, cGMP, GAMP 5, ALCOA+, and 21 CFR Part 11 requirements.
  • Collaborate with Automation, Engineering, IT, Manufacturing, and Quality teams during project execution.
  • Support audits and regulatory inspections by providing validation documentation and technical expertise.
  • Review system lifecycle documentation and maintain validated system status.
Required Qualifications
  • Bachelor’s degree in engineering, Computer Science, Information Systems, or related technical discipline.
  • 5+ years of Computer System Validation experience in the pharmaceutical, biotechnology, or medical device industry.
  • Hands-on experience validating Emerson DeltaV systems is required.
  • Strong understanding of GAMP 5, FDA regulations, cGMP, and 21 CFR Part 11.
  • Experience developing and executing IQ, OQ, and PQ protocols.
  • Experience with change control, deviation investigations, CAPA, and risk assessments.
  • Excellent technical writing and documentation skills.
  • Strong communication and cross-functional collaboration skills.
Preferred Qualifications
  • Experience with Manufacturing Execution Systems (MES), SCADA, PLCs, or process automation systems.
  • Knowledge of electronic batch records (EBR) and manufacturing systems integration.
  • Experience supporting commissioning, qualification, and validation (CQV) projects in biologics or sterile manufacturing environments.
Technical Skills
  • Emerson DeltaV (Required)
  • Computer System Validation (CSV)
  • GAMP 5
  • 21 CFR Part 11
  • cGMP/FDA Compliance
  • IQ/OQ/PQ Protocols
  • Risk Assessments
  • Change Control
  • CAPA
  • Commissioning & Qualification (CQV)
  • Automation Systems Validation
  • Technical Documentation
Preferred Industry Experience
  • Biotechnology
  • Pharmaceutical Manufacturing
  • GMP-Regulated Facilities
  • Cell & Gene Therapy or Biologics Manufacturing (preferred)
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