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Computer System Validation Manager Jobs in Fremont, CA

Supermicro

System Validation Engineer

San Jose, CA · On-site

$100K - $113K/yr

Manages standard system environmental and reliability validations with AI approaches during the ... Bachelor's degree in computer engineering/ electrical engineering disciplines required with strong ...

Supermicro

System Validation Engineer

San Jose, CA · On-site

$90K - $115K/yr

Qualifications: * Bachelor's degree in Computer Engineering, Computer Science, Electrical ... Ability to work effectively in a fast-paced environment and manage multiple priorities under ...

Supermicro

System Validation Engineer

San Jose, CA · On-site

$100K - $113K/yr

Supermicro Computer is currently looking for talented System Validation Engineer to partner with ... Work with customers and product management to understand production use of the product and ...

Lyte

System Validation Engineer

Sunnyvale, CA · On-site

$130K - $230K/yr

... management ICs. Your core strength: methodically isolating problems and localizing them to a ... Lead PCB and system-level bringup, first power-on through functional validation * Isolate failures ...

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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 Jul 27, 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 July 2026, with employment types broken down into 58% Full Time, and 42% Contract. Highlights an 100% In-person job distribution, with an average salary of $115,395 per year, or $55.5 per hour.

CSV Consultant (Computer System Validation)

Stark Pharma Solutions Inc

Redwood City, CA • On-site

Contractor

Posted 14 days ago

Job description

Job Title: CSV Consultant (Computer Systems Validation)

Location: Redwood City, CA

Type: Contract

Job Summary

We are seeking an experienced CSV Consultant to support validation activities across multiple GxP-regulated systems within a pharmaceutical environment. This role will focus on computer systems validation, revalidation efforts, data migration activities, and documentation management for critical business and quality systems.

The ideal candidate will have strong experience with validated systems, change control processes, and regulatory compliance in GMP/GxP environments.

Key Responsibilities

  • Lead and support validation activities for GxP-regulated systems including:
  • SAS Studio
  • Veeva Quality Docs
  • CTMS
  • TraceLink
  • Argus
  • Support system revalidation and data migration projects to ensure compliance and data integrity
  • Develop, review, and execute validation documentation including:
  • Validation Plans
  • User Requirements Specifications (URS)
  • Risk Assessments
  • IQ/OQ/PQ protocols
  • Traceability Matrices
  • Summary Reports
  • Create and support User Acceptance Testing (UAT) scripts and execution activities
  • Manage change control documentation and support deviation resolution activities
  • Ensure validation activities align with FDA, GAMP5, and GxP compliance requirements
  • Collaborate with IT, Quality, Clinical, and Business stakeholders to support validated system implementations and updates
  • Maintain accurate and compliant documentation throughout the system lifecycle

Required Qualifications

  • Bachelor’s degree in Computer Science, Engineering, Life Sciences, or related field
  • 5+ years of experience in Computer Systems Validation (CSV) within pharmaceutical or biotech environments
  • Hands-on experience validating GxP systems and supporting regulated system implementations
  • Strong knowledge of FDA 21 CFR Part 11, GAMP5, and GxP requirements
  • Experience with validation documentation, UAT execution, and change control processes
  • Familiarity with systems such as SAS Studio, Veeva, CTMS, TraceLink, or Argus
  • Strong analytical, documentation, and communication skills