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Computer System Validation Manager Jobs in California

Wellington Foods Inc

Validation Manager

Corona, CA · On-site

$95K - $105K/yr

This position requires strong communication skills, computer skills, and experience in management ... The position reports to the Vice-President of Quality Systems. MAJOR FUNCTIONS & RESPONSIBILITIES:

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Computer System Validation Manager information

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$46.9K

$104K

$158.4K

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

As of Jun 6, 2026, the average yearly pay for computer system validation manager in California is $104,035.00, according to ZipRecruiter salary data. Most workers in this role earn between $73,500.00 and $130,300.00 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 California? The most popular types of Computer System Validation jobs in California are:
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Computer System Validation Manager jobs near you
Computer System Validation Engineer

Computer System Validation Engineer

Katalyst HealthCares & Life Sciences

Vacaville, CA • On-site

Full-time

This job post has expired today. Applications are no longer accepted.

Job description

Computer System Validation Engineer

As a Computer System Validation (CSV) Engineer in the pharmaceutical industry, this role is responsible for ensuring that computer-based systems such as Manufacturing Execution Systems (MES), process control software, and automation platforms comply with GxP, FDA 21 CFR Part 11, EU Annex 11, and other applicable regulatory requirements.

Develop, execute, and review validation deliverables, including Validation Plans, User Requirements Specifications (URS), IQ/OQ/PQ protocols, and Summary Reports.

Collaborate with Quality Assurance, IT, Engineering, and Production teams to ensure system compliance and data integrity.

Support internal audits and inspections, ensuring readiness and adherence to regulatory expectations.

Provide training to stakeholders on validation requirements and best practices.

Maintain validation lifecycle documentation and change control records.

Experience with Computer System Validation (CSV) in a regulated pharmaceutical or biotech environment.

Strong knowledge of GxP, FDA 21 CFR Part 11, and EU Annex 11.

Proficiency in authoring and executing validation documentation.

Katalyst Healthcares & Life Sciences logo

About Katalyst Healthcares & Life Sciences

Sourced by ZipRecruiter

Katalyst HealthCares & Life Sciences is a Global Contract Research Organization that provides services in Clinical Research, Manufacturing & Quaity, Regulatory Affairs Areas.. Industries Serving: Pharmaceutical Bio-Pharmaceutical Medical Device Cosmeceuticals & Cosmetics Food & Beverage Clinical Research Scientific Areas Covering: Clinical Research Manufacturing Quality & Validations Regulatory Affairs Intellectual Property Through our in-house team expertise, associates and alliances in the US, Europe and Asia, we can rapidly deliver services, technology, processes and workforce globally, either virtually or integrate into client project space, providing oversight and expertise for individual needs to total end-to-end support for all kinds of clinical trials of Pharma, Biotech, Medical Device and all other scientific products and their manufacturing.

Industry

Scientific research and development services

Company size

51 - 200 Employees

Headquarters location

South Plainfield, NJ, US

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