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Computer System Validation Manager Jobs in Fremont, 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 ...

Ayar Labs

Sr. Engineer, System Validation

San Jose, CA · On-site

$160K - $192K/yr

Sr. Engineer, System Validation Location: San Jose (on-site) Ayar Labs is shattering AI data ... Manage project schedules and execution to meet product timelines and customer demand, while ...

Ayar Labs

Sr. Engineer, System Validation

San Jose, CA · On-site

$160K - $192K/yr

Sr. Engineer, System Validation Location: San Jose (on-site) Ayar Labs is shattering AI data ... Manage project schedules and execution to meet product timelines and customer demand, while ...

Katalyst CRO

CSV Engineer

Redwood City, CA · On-site

Katalyst CRO is looking for an experienced and well-rounded CSV (Computer System Validation ... • Managing change controls including creation, execution, and closure • Supporting data ...

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All JobsComputer System Validation JobsComputer System Validation Manager JobsComputer System Validation Manager Jobs in Fremont, CA

Computer System Validation Manager information

See Fremont, CA salary details

$52K

$115.4K

$175.7K

How much do computer system validation manager jobs pay per year?

As of Aug 8, 2026, the average yearly pay for computer system validation manager in Fremont, CA is $115,395.00, according to ZipRecruiter salary data. Most workers in this role earn between $81,600.00 and $144,500.00 per year, depending on experience, location, and employer.

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

To thrive as a Computer System Validation Manager, you need expertise in computer system validation regulations (such as GxP, FDA 21 CFR Part 11), strong project management skills, and a background in life sciences or IT. Familiarity with validation lifecycle documentation tools, quality management systems (QMS), and compliance software is often required, along with relevant certifications like PMP or CSV-related credentials. Exceptional attention to detail, analytical thinking, and effective communication are crucial soft skills for coordinating cross-functional teams and ensuring regulatory compliance. These skills and qualifications are vital to ensure validated systems meet regulatory standards, minimize compliance risks, and support organizational quality objectives.

What are some common challenges a computer system validation manager faces during system implementation projects?

A Computer System Validation Manager often encounters challenges such as aligning validation activities with evolving regulatory requirements, managing tight project timelines, and coordinating between multiple stakeholders like IT, Quality Assurance, and business users. Ensuring thorough documentation and traceability, while adapting to technology updates or scope changes, can also be demanding. Proactive communication and strong project management skills are essential to mitigate risks and ensure successful, compliant system implementations.

What does a computer system validation manager do?

A Computer System Validation Manager is responsible for ensuring that computer systems used in regulated industries, such as pharmaceuticals or biotechnology, meet all required compliance standards. They oversee the planning, execution, and documentation of validation activities to ensure systems are reliable, accurate, and secure. Their duties include managing validation projects, writing protocols, coordinating with IT and quality assurance teams, and ensuring adherence to regulations like FDA 21 CFR Part 11. This role is critical for maintaining product quality and regulatory compliance.

What is the difference between Computer System Validation Manager vs Computer System Validation Specialist?

AspectComputer System Validation ManagerComputer System Validation Specialist
CertificationsGAMP, CQE, CSQEGAMP, CQE, CSQE
Work EnvironmentManagement, oversight, strategic planningExecution, testing, documentation
Industry UsagePharmaceutical, biotech, regulated industriesPharmaceutical, biotech, regulated industries
Primary FocusLeading validation projects, team coordinationPerforming validation activities, testing

The main difference between a Computer System Validation Manager and a Computer System Validation Specialist lies in their roles. The manager oversees validation projects, manages teams, and ensures compliance, while the specialist executes validation tasks and documents testing procedures. Both roles require similar certifications and are vital in regulated industries like pharmaceuticals and biotech.

What are the most commonly searched types of Computer System Validation jobs in Fremont, CA? The most popular types of Computer System Validation jobs in Fremont, CA are:
What are popular job titles related to Computer System Validation Manager jobs in Fremont, CA? For Computer System Validation Manager jobs in Fremont, CA, the most frequently searched job titles are:
What job categories do people searching Computer System Validation Manager jobs in Fremont, CA look for? The top searched job categories for Computer System Validation Manager jobs in Fremont, CA are:
What cities near Fremont, CA are hiring for Computer System Validation Manager jobs? Cities near Fremont, CA with the most Computer System Validation Manager job openings:
Computer System Validation Manager jobs near you
Infographic showing various Computer System Validation Manager job openings in Fremont, CA as of August 2026, with employment types broken down into 77% Full Time, 6% Part Time, and 17% Contract. Highlights an 83% In-person, 6% Hybrid, and 11% Remote job distribution, with an average salary of $115,395 per year, or $55.5 per hour.

Senior Manager, GxP Electronic System Validation QA

Revolution Medicines

Redwood City, CA • Hybrid

Other

Re-posted 20 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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