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Computer System Validation Manager Jobs (NOW HIRING)

Compsciprep LLC

CSV Validation Consultant

Chicago, IL · On-site

Computer System Validation (CSV) / Validation Consultant - Life Sciences Location: Multiple ... Knowledge of CTMS (Clinical Trial Management System) * Preparation and review of validation ...

New

CAI

Computer Systems Validation Engineer

Indianapolis, IN · On-site

$75K - $106K/yr

We provide commissioning, qualification, validation, startup, project management, and other ... System & Industry Expertise Support CSV activities across various platforms including MES, DCS ...

CAI

Computer Systems Validation Engineer

Baltimore, MD · On-site

$75K - $106K/yr

We provide commissioning, qualification, validation, startup, project management, and other ... System & Industry Expertise Support CSV activities across various platforms including MES, DCS ...

CAI

Computer Systems Validation Engineer

Indianapolis, IN · On-site

$75K - $106K/yr

We provide commissioning, qualification, validation, startup, project management, and other ... System & Industry Expertise Support CSV activities across various platforms including MES, DCS ...

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Computer System Validation Manager information

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$47.5K

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$160.5K

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

As of Aug 12, 2026, the average yearly pay for computer system validation manager in the United States is $105,415.00, according to ZipRecruiter salary data. Most workers in this role earn between $74,500.00 and $132,000.00 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.

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What cities are hiring for Computer System Validation Manager jobs? Cities with the most Computer System Validation Manager job openings:
What are the most commonly searched types of Computer System Validation jobs? The most popular types of Computer System Validation jobs are:
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Computer System Validation Manager jobs near you
Infographic showing various Computer System Validation Manager job openings in the United States 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 $105,415 per year, or $50.7 per hour.

Senior Computer Systems Validation Engineer

Vaxcyte

San Carlos, CA • On-site

Full-time

Re-posted 17 days ago

Job description

Join our Mission to Protect Humankind!
Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, which have serious and costly health consequences when left unchecked. Working to eradicate or treat bacterial infections such as invasive pneumococcal disease, Group A Strep, and Shigella is just the beginning. Our path to success is clear and well-defined, and Vaxcyte is set up to go the distance.
WHAT we do is every bit as important as HOW we do it! Our work together is guided by four enduring core values:
*RETHINK CONVENTION: We bring creative and intellectual diversity to every facet of the work we do in order to innovate and re-innovate the way vaccines are delivered.
*AIM HIGH: We embody our collectively audacious goal to courageously make the most complex biologics ever attempted to protect humankind.
*LEAD WITH HEART: Everyone leads at Vaxcyte with a kindness-first, inclusive approach to collaboration and vigorous debate that advances our business objectives.
*MODEL EXCELLENCE: The magnitude of our challenge requires our shared commitment to demonstrating integrity, accountability, equality and clarity across communications and decision making.
Summary:
The Senior Computer Systems Validation (CSV) Engineer is responsible for leading validation activities for cloud based GxP systems to ensure they meet regulatory, quality, and operational requirements throughout the system lifecycle. The role focuses on traditional Computer System Validation with application of risk-based Computer Software Assurance (CSA) principles where appropriate.
The individual will work closely with IT and Quality teams to validate and maintain GxP systems across their lifecycle. Strong experience validating relational databases, cloud infrastructure, and integrated applications in regulated biotech or pharmaceutical environments is required.
This is a hands-on role requiring authoring and executing validation documents and protocols for GAMP 5 systems.
This is a hybrid role with minimum of 3 days a week onsite at San Carlos, CA location.
Essential Functions:
  • Hands-on lead full lifecycle Computer System Validation activities for cloud based GxP systems including databases, and applications.
  • Author, update, execute and maintain validation deliverables such as Validation Plans, User Requirements, Functional Specifications, Risk Assessments, Traceability Matrices, IQ, OQ, PQ protocols, and Summary Reports.
  • Perform risk assessments to define validation scope, testing strategy, and documentation requirements in alignment with CSA principles.
  • Define and execute validation strategies for data platforms and system components, ensuring systems meet defined functional, security, and data integrity requirements
  • Assess and validate end to end data flows between upstream source systems and downstream applications to ensure accuracy, completeness, and traceability.
  • Evaluate system changes for validation impact and ensure validated systems remain compliant through appropriate testing and documentation.
  • Ensure validation activities align with automated build and deployment pipelines, confirming that system releases maintain validated state and appropriate validation evidence is generated.
  • Support change control, deviation management, periodic review, and lifecycle management of validated systems.
  • Participate in internal audits and regulatory inspections, providing validation documentation and rationale as required.
  • Contribute to continuous improvement of validation procedures aligned with evolving CSA guidance and cloud delivery models.
Requirements:
  • Bachelor's degree in Computer Science, Engineering, Life Sciences, or related field, or equivalent professional experience.
  • Minimum 7 years of experience in Computer System Validation within biotech manufacturing and lab data systems. Other combinations of education and/or experience may be considered.
  • Must have technical knowledge of IT infrastructure, software engineering, programming, databases and data integrations.
  • Experience working in modern system environments utilizing CI/CD pipelines or automated release processes.
  • Strong hands-on experience validating GAMP 5 systems for biotech manufacturing.
  • Deep understanding of FDA 21 CFR Part 11, Part 210, Part 211, Annex 11, data integrity requirements, and risk-based validation methodologies.
  • Strong technical writing skills and ability to create comprehensive validation documentation.
  • Ability to communicate validation risks and requirements clearly to IT and Quality stakeholders.

Other combinations of education and/or experience may be considered.
Preferred Qualifications:
  • Hands-on experience validating cloud based GxP systems, specifically Azure.
  • Familiarity with infrastructure as code frameworks like GitHub, Terraform etc.
  • Experience applying CSA principles to custom data applications in GxP cloud.
  • Microsoft Azure or similar technical certifications.

Reports to: Senior Manager, Data Systems
Location: San Carlos, CA
Work Arrangement (may be adjusted based on business needs, job responsibilities, or changes to company policy):
Hybrid (minimum of 3 days per week onsite)
Compensation:
The compensation package will be competitive and includes comprehensive benefits and an equity component.
Salary Range: $164,000 - $190,000 (SF Bay Area). Salary ranges for non-California locations may vary.
Relocation:
This role is not eligible for relocation assistance.
#LI-JN1
We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.
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About Vaxcyte

Sourced by ZipRecruiter

Industry

Biotechnology research and development

Company size

51 - 200 Employees

Headquarters location

San Carlos, CA, US

Year founded

2013

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