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Computer System Validation Jobs in Mountain View, CA

Cypress HCM

Senior System Validation Engineer

San Jose, CA · Hybrid

$122K - $167K/yr

S. in Computer Engineering, Electrical Engineering, or related field. * 5+ years of experience in system validation, memory interfaces, or related semiconductor work. * Must have expertise in high ...

Katalyst CRO

CSV Engineer

Redwood City, CA · On-site

Katalyst CRO is looking for an experienced and well-rounded CSV (Computer System Validation) Consultant to support multiple ongoing projects within a pharmaceutical environment. The ideal candidate ...

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Computer System Validation information

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How much do computer system validation jobs pay per hour?

As of Jul 31, 2026, the average hourly pay for computer system validation in Mountain View, CA is $64.08, according to ZipRecruiter salary data. Most workers in this role earn between $49.33 and $76.01 per hour, depending on experience, location, and employer.

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.

What is a Computer System Validation job?

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 the Computer System Validation position, 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 is the work of computer system validation?

Computer System Validation (CSV) is the process of ensuring that computer systems used in regulated environments function correctly and comply with industry standards. It involves documenting and testing software, hardware, and related processes to verify they meet specified requirements, often using validation protocols and tools. CSV is essential in industries like pharmaceuticals and healthcare to ensure data integrity and regulatory compliance.

What degree is best for cis jobs?

For Computer System Validation (CSV) roles, a bachelor's degree in computer science, information technology, life sciences, or engineering is typically preferred. Relevant certifications such as GxP or validation-specific training can enhance job prospects, and strong knowledge of regulatory requirements like FDA or EMA guidelines is beneficial.

What is the salary of SoC validation engineer?

The salary of a SoC validation engineer typically ranges from $80,000 to $130,000 annually, depending on experience, location, and company size. Professionals in this role often have skills in hardware description languages and verification tools, which can influence compensation.
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Computer System Validation jobs near you
Infographic showing various Computer System Validation job openings in Mountain View, CA as of July 2026, with employment types broken down into 100% Full Time. Highlights an 100% In-person job distribution, with an average salary of $133,283 per year, or $64.1 per hour.

Senior Manager, GxP Electronic System Validation QA

Revolution Medicines

Redwood City, CA • Hybrid

Other

Re-posted 11 days ago

Job description

The Opportunity:

  • Serve as the Computer System Validation (CSV) QA subject matter expert and provide guidance on the interpretation and application of global GxP regulations and guidance related to computerized systems, electronic records, electronic signatures, and data integrity, including FDA 21 CFR Part 11, EU Annex 11, and GAMP principles.

  • Provide Quality Assurance oversight of CSV activities for internal and external GxP computerized systems, ensuring validation activities are conducted in compliance with regulatory requirements and company Software Development Life Cycle (SDLC) standards.

  • Implement and promote best practices for data governance and data integrity, ensuring computerized systems meet GxP compliance requirements throughout their lifecycle.

  • Lead and provide oversight for Data Integrity and Computer System Validation programs and activities.

  • Review and approve CSV documentation, including validation plans, requirements, risk assessments, test protocols, validation reports, and system retirement documentation.

  • Review and approve GxP change controls, deviations, CAPAs, and other quality records to ensure compliance with quality and regulatory requirements.

  • Lead supplier audits, assessments, qualification, and requalification activities for electronic system vendors and service providers.

  • Support the development, implementation, and continuous improvement of computerized system policies, procedures, validation methodologies, and quality processes.

  • Collaborate cross-functionally to identify compliance risks, process gaps, and opportunities for improvement, and drive implementation of effective solutions.

  • Provide guidance, education, and training to cross-functional teams on risk-based validation approaches and GxP system deployment.

  • Support inspection readiness initiatives and represent Quality Assurance during partner audits, customer audits, and regulatory inspections.

  • Monitor evolving regulatory expectations and industry trends related to computerized systems validation, data integrity, and digital quality systems.

Required Skills, Experience and Education:

  • Bachelor's degree in computer science, Information Systems, Engineering, Life Sciences, or a related discipline, or equivalent combination of education and experience.

  • Minimum 8 years of Quality Assurance experience in the pharmaceutical, biotechnology, or life sciences industry supporting GxP computerized systems.

  • Extensive experience in Computerized Systems Validation (CSV) and/or Computer Software Assurance (CSA) with strong knowledge of GAMP 5, SDLC, and risk-based validation methodologies.

  • Expert knowledge of FDA 21 CFR Part 11, EU Annex 11, Data Integrity, and ALCOA+ principles, including electronic records and electronic signatures compliance requirements.

  • Broad experience with GxP computerized systems and the ability to author, review, and approve validation deliverables, risk assessments, testing documentation, and compliance-related records throughout the system lifecycle.

Preferred Skills:

  • Experience supporting regulatory inspections, internal audits, and supplier/vendor audits.

  • Familiarity with cloud-based/SaaS platforms, vendor qualification, and third-party risk management.

  • Excellent analytical, problem-solving, and cross-functional collaboration skills.

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