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Senior Computer System Validation Csv Jobs (NOW HIRING)

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 ...

Valspec

IT Validation Lead (GxP / CSV)

San Diego, CA

$65 - $80/hr

Senior Computer System Validation (CSV) Quality Engineer A leading biopharmaceutical manufacturer in the San Diego area is seeking a Senior CSV Quality Engineer to join their Quality organization for ...

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

As of Jul 30, 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 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.

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

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 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.
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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 July 2026, with employment types broken down into 1% As Needed, 82% Full Time, 14% Part Time, and 3% Contract. Highlights an 93% Physical, 2% Hybrid, and 5% Remote job distribution, with an average salary of $134,726 per year, or $64.8 per hour.

Computer System Validation (CSV) Lead

Intellectt INC

Lancaster, PA • On-site

Contractor

Re-posted 10 days ago

Job description

Hello,

I hope you're doing well.

My name is Mahalakshmi, and I’m reaching out from Intellectt Inc. regarding an exciting contract opportunity for a Computer System Validation (CSV) Lead based in Lancaster, PA with one of our prestigious clients.
I would love to connect and discuss this opportunity in more detail. Please feel free to share your updated resume at mahalakshmi.n@intellectt.com  OR +1 (732) 737 8381

Job Title: Computer System Validation (CSV) Lead
Location: Lancaster, PA

Position Summary

We are seeking an experienced Computer System Validation (CSV) Lead to support validation activities for a newly constructed Sterile Drug Product Clinical Manufacturing Facility. This role will lead CSV strategy, execution, and compliance activities for GMP computerized systems and automation platforms in a fast-paced project environment.

Key Responsibilities

  • Lead CSV strategy and execution for GMP computerized systems and automation platforms.
  • Author and execute CSV lifecycle documents including Validation Plans, URS, Risk Assessments, IQ/OQ/PQ protocols, Traceability Matrices, and Summary Reports.
  • Support commissioning, qualification, and validation activities for manufacturing and automation systems.
  • Collaborate with Automation, Engineering, Quality, Manufacturing, and IT teams.
  • Lead deviation investigations, troubleshooting, and validation issue resolution.
  • Ensure compliance with GAMP5, 21 CFR Part 11, Data Integrity, and company validation standards.
  • Support testing and validation of control systems, SCADA/HMI platforms, instrumentation, OT infrastructure, and manufacturing equipment.

Required Qualifications

  • Bachelor’s degree in Engineering, Computer Science, Automation, Life Sciences, or related field.
  • 10–15 years of CSV, Automation, or Validation Engineering experience in pharmaceutical or biotech industries.
  • Strong experience in GMP manufacturing environments, preferably sterile or aseptic processing facilities.
  • Hands-on experience with CSV documentation, protocol execution, and validation lifecycle management.
  • Strong knowledge of GAMP5, 21 CFR Part 11, CSA/CSV methodologies, and Data Integrity principles.
  • Excellent technical writing, troubleshooting, and communication skills.

Preferred Technical Experience

  • AVEVA System Platform, Allen Bradley PLC, Siemens PLC, PI Historian, SCADA/HMI systems.
  • OT networks, instrumentation, industrial communications, and field I/O testing.
  • Experience with robotic isolators, filling lines, lyophilizers, autoclaves, and wash systems.
  • Kneat validation platform experience preferred.

Thanks & Regards,
Mahalakshmi
Junior Recruiter
Intellectt Inc 
mahalakshmi.n@intellectt.com
Direct: +1 (732) 737 8381