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Computer System Validation Csv Jobs in Seattle, WA

Valspec

Validation Engineer (CSV)

Seattle, WA

Lead Computer System Validation (CSV) activities for DeltaV-based manufacturing systems. * Develop and execute validation deliverables including: * Validation Plans * Risk Assessments * Requirements ...

Valspec

Validation Engineer (CSV)

Redmond, WA · On-site

Lead Computer System Validation (CSV) activities for DeltaV-based manufacturing systems. * Develop and execute validation deliverables including: * Validation Plans * Risk Assessments * Requirements ...

Systimmune

Director, Information Technology

Redmond, WA · On-site

$180 - $250/hr

  • Medical

  • Dental

  • Vision

  • Retirement

  • PTO

Lead computer system validation (CSV) and qualification activities for GxP-relevant systems, partnering with Quality Assurance and Regulatory functions to support audits, inspections, and remediation.

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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 Aug 16, 2026, the average hourly pay for computer system validation csv in Seattle, WA is $58.95, according to ZipRecruiter salary data. Most workers in this role earn between $44.33 and $73.32 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.

What are the most commonly searched types of Computer System Validation Csv jobs in Seattle, WA?

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For Computer System Validation Csv jobs in Seattle, WA, the most frequently searched job titles are:

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Computer System Validation Csv jobs near you
Infographic showing various Computer System Validation Csv job openings in Seattle, WA as of August 2026, with employment types broken down into 1% As Needed, 83% Full Time, 12% Part Time, and 4% Contract. Highlights an 92% Physical, 2% Hybrid, and 6% Remote job distribution, with an average salary of $122,619 per year, or $59 per hour.

Computer System Validation Engineer

Katalyst Healthcares and Lifesciences

Bothell, WA • On-site

Other

Posted 2 days ago

New

Job description

Job Summary:
  • We are seeking an experienced Computer System Validation (CSV) Engineer/Contractor to lead and execute validation activities for GxP computerized systems, with a strong focus on Manufacturing Execution Systems (MES) in a pharmaceutical or biologics manufacturing environment.
  • The ideal candidate will have expertise in CSV lifecycle management, GAMP, 21 CFR Part 11, protocol development and execution, and cross-functional collaboration to ensure compliance with regulatory and quality requirements.

Roles & Responsibilities:
  • Lead and execute Computer System Validation (CSV) activities for GxP computerized systems and applications throughout the validation lifecycle.
  • Develop, review, execute, and maintain CSV documentation, including Validation Plans, User Requirements Specifications (URS), Functional/Design Specifications, Risk Assessments, IQ, OQ, PQ protocols, Traceability Matrices, Validation Summary Reports, and SOPs.
  • Support the validation of Manufacturing Execution Systems (MES) and ensure compliance with internal procedures and regulatory requirements.
  • Partner with Business Owners, Technical Owners, Quality Assurance (QA), Manufacturing, Engineering, and IT teams to develop validation deliverables and system requirements.
  • Assist with User Acceptance Testing (UAT) by supporting protocol execution, documenting test results, investigating test failures, and ensuring testing complies with established procedures.
  • Develop system requirements and specifications for computerized systems used in GxP manufacturing operations.
  • Perform risk-based validation activities in accordance with GAMP methodology.
  • Ensure compliance with cGMP, GxP, GAMP, SDLC, and 21 CFR Part 11 regulations governing computerized systems and electronic records.
  • Support change control, incident management, and system lifecycle activities using IT service management tools.
  • Collaborate with cross-functional teams to resolve validation issues and maintain audit-ready documentation.
  • Provide on-site support throughout User Acceptance Testing (UAT) execution.

Requirements / Qualifications:
  • Bachelor's degree in Life Sciences, Engineering, Information Technology, Computer Science, or a related discipline (or equivalent industry experience).
  • 4+ years of experience in Computer System Validation (CSV) within a GxP-regulated pharmaceutical, biotechnology, or biologics manufacturing environment.
  • Strong hands-on experience with Manufacturing Execution Systems (MES) validation (e.g., Emerson Syncade).
  • Strong understanding of Computer System Validation (CSV) principles and validation lifecycle activities.
  • Experience developing and executing CSV documentation, including:
  • Validation Plans
  • User Requirements Specifications (URS)
  • Functional/Design Specifications
  • Risk Assessments
  • IQ/OQ/PQ Protocols
  • Validation Summary Reports
  • Traceability Matrices
  • Standard Operating Procedures (SOPs)
  • Strong knowledge of GAMP 5, 21 CFR Part 11, cGMP, GxP, SDLC, and Good Documentation Practices (GDP).
  • Experience with User Acceptance Testing (UAT), protocol drafting, execution, and defect management.
  • Familiarity with ERP systems (e.g., SAP, Oracle) and Electronic Batch Records (EBR) systems (e.g., InfoBatch).
  • Experience with Quality Management Systems (e.g., Veeva) and IT Service Management tools (e.g., ServiceNow).
  • Knowledge of pharmaceutical manufacturing, laboratory systems, and biologics manufacturing processes.
  • Excellent technical writing, communication, problem-solving, and cross-functional collaboration skills.
  • Ability to work independently while managing multiple validation activities in a fast-paced, regulated environment.

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