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Computer System Validation Csv Jobs (NOW HIRING)

Sunrise Systems Inc

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Computer Systems Validation Engineer (MES)_26-02885

Bothell, WA · On-site

$73 - $75/hr

Understanding of computer system validation (CSV). Education and Experience: * Bachelor's degree in a life sciences or engineering / IT discipline or equivalent industry experience (a combination of ...

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Computer System Validation CSV information

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

As of Jun 26, 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 the Computer System Validation Csv position, and why are they important?

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) job?

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 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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What cities are hiring for Computer System Validation Csv jobs? Cities with the most Computer System Validation Csv job openings:
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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 June 2026, with employment types broken down into 99% Full Time, and 1% Nights. Highlights an 93% Physical, 2% Hybrid, and 5% Remote job distribution, with an average salary of $107,747 per year, or $51.8 per hour.
Computer System Validation (CSV) Lead

Computer System Validation (CSV) Lead

Intellectt INC

Lancaster, PA • On-site

Contractor

Posted 7 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