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Computer System Validation Jobs in Redmond, WA (NOW HIRING)

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

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

Automation CSV Engineer

Redmond, WA · On-site

$120 - $180/hr

Minimum of 5 years of experience supporting GMP automation systems, computer system validation (CSV), automation testing, or technical writing activities within regulated industries. * Hands‑on ...

New

HW Dev Engineer, Antenna System Validation

Redmond, WA · On-site

$117.30 - $160/hr

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

  • PTO

Bachelor''s degree in Electrical Engineering, Computer Engineering, or a related technical field ... Experience designing phased array or antenna systems for aerospace, defense, or telecommunications ...

New

HW Dev Engineer, Antenna System Validation

Redmond, WA · On-site

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

  • PTO

... to validation. You will work alongside antenna, systems, and software engineers to build antennas ... Computer Engineering, or a related technical field - 4+ years of experience in electrical ...

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Computer System Validation information

See Redmond, WA salary details

$11

$60

$96

How much do computer system validation jobs pay per hour?

As of Aug 19, 2026, the average hourly pay for computer system validation in Redmond, WA is $60.83, according to ZipRecruiter salary data. Most workers in this role earn between $46.83 and $72.16 per hour, depending on experience, location, and employer.

What is a computer system validation?

A Computer System Validation (CSV) job involves ensuring that computer systems used in regulated industries, such as pharmaceuticals and medical devices, meet compliance and regulatory requirements. CSV professionals develop and execute validation protocols to confirm that software, hardware, and processes function as intended and maintain data integrity. They work with quality assurance, IT, and regulatory teams to document compliance with standards like FDA 21 CFR Part 11 and GxP. This role is critical in maintaining system reliability, product quality, and patient safety.

What are the key skills and qualifications needed to thrive in computer system validation, and why are they important?

To excel in Computer System Validation, candidates typically need a background in computer science, engineering, or life sciences, with expertise in validating software and systems in regulated environments such as pharmaceuticals or medical devices. Familiarity with tools like validation documentation software, GAMP 5 guidelines, FDA 21 CFR Part 11 regulations, and potentially certifications like CSV Professional or Six Sigma is highly valued. Strong attention to detail, analytical thinking, and effective communication skills help professionals work collaboratively and document findings precisely. These abilities ensure compliance, data integrity, and the reliability of computerized systems critical to safety and quality.

What are some typical challenges faced in computer system validation roles?

Professionals in Computer System Validation often encounter challenges such as keeping up with evolving regulatory requirements, ensuring complete and accurate documentation, and coordinating with cross-functional teams to implement validation protocols. Balancing thoroughness with project deadlines can also be demanding, as every validation step must stand up to external audits. However, these challenges provide valuable experience, strengthen project management abilities, and emphasize teamwork—key attributes that support career advancement into validation leadership or quality assurance roles.

Is computer system validation a good field?

Computer System Validation (CSV) is a vital part of regulated industries like pharmaceuticals and biotech, ensuring that computer systems meet quality and compliance standards. It offers opportunities for professionals with skills in validation protocols, regulatory requirements, and tools like GxP and 21 CFR Part 11. The field provides steady employment, career growth, and the chance to work on critical quality assurance processes.

What are popular job titles related to Computer System Validation jobs in Redmond, WA?

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

What job categories do people searching Computer System Validation jobs in Redmond, WA look for?

The top searched job categories for Computer System Validation jobs in Redmond, WA are:

Infographic showing various Computer System Validation job openings in Redmond, 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 $126,535 per year, or $60.8 per hour.

Computer System Validation Engineer

Katalyst Healthcares and Lifesciences

Bothell, WA • On-site

Other

Posted 5 days ago


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.