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Senior Computer System Validation Csv Jobs (NOW HIRING)

Mirus Consulting Group

CSV Specialist

Gurabo, PR · On-site

... provides computer system validation and information technology consulting services to ... The CSV Specialist will be responsible for managing and executing all activities related to ...

Mirus Consulting Group

CSV Specialist

Gurabo, PR · On-site

... provides computer system validation and information technology consulting services to ... The CSV Specialist will be responsible for managing and executing all activities related to ...

Mirus Consulting Group

CSV Specialist

Gurabo, PR · On-site

... provides computer system validation and information technology consulting services to ... The CSV Specialist will be responsible for managing and executing all activities related to ...

Moriah Engineering

PR · On-site

$90K - $118K/yr

The ideal candidate will have extensive expertise in validation and compliance, computer system validation (CSV), and familiarity with DeltaV, Aveeva PI. A background in the biotechnology industry is ...

Moriah Engineering

CSV Lead

Carolina, PR

$90K - $118K/yr

The ideal candidate will have extensive expertise in validation and compliance, computer system validation (CSV), and familiarity with DeltaV, Aveeva PI. A background in the biotechnology industry is ...

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Senior Computer System Validation Csv information

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How much do senior computer system validation csv jobs pay per hour?

As of Jul 10, 2026, the average hourly pay for senior computer system validation csv in the United States is $64.77, according to ZipRecruiter salary data. Most workers in this role earn between $51.68 and $73.56 per hour, depending on experience, location, and employer.

What is the difference between Senior Computer System Validation Csv vs Computer System Validation Specialist?

AspectSenior Computer System Validation CsvComputer System Validation Specialist
CertificationsGxP, 21 CFR Part 11, CSV certificationsGxP, 21 CFR Part 11, CSV certifications
Work EnvironmentRegulated industries like pharma, biotech, medical devicesRegulated industries like pharma, biotech, medical devices
ResponsibilitiesLeading validation projects, ensuring compliance, mentoringExecuting validation activities, documentation, testing

While both roles require similar certifications and work in regulated environments, the Senior Computer System Validation Csv typically involves leading projects and overseeing compliance efforts, whereas the Computer System Validation Specialist focuses on executing validation tasks and documentation. The senior role often requires more experience and leadership responsibilities.

What are the key skills and qualifications needed to thrive as a Senior Computer System Validation (CSV) professional, and why are they important?

To excel as a Senior Computer System Validation (CSV) professional, you need deep knowledge of regulatory compliance (such as FDA 21 CFR Part 11), validation lifecycle methodologies, and a background in computer science, engineering, or life sciences. Familiarity with validation management tools, risk assessment software, and quality management systems (QMS) is typically required, along with certifications like GAMP or Six Sigma being highly valued. Outstanding analytical skills, attention to detail, and strong communication abilities set high performers apart in this role. These competencies ensure validated systems meet regulatory requirements, maintain data integrity, and support quality operations in regulated industries.

What are some common challenges Senior Computer System Validation (CSV) professionals face when working on large-scale projects?

Senior CSV professionals often encounter challenges such as coordinating validation activities across multiple departments, managing evolving regulatory requirements, and ensuring thorough documentation throughout the project lifecycle. They also need to balance project timelines with the need for comprehensive testing and risk assessments. Effective communication and collaboration with IT, QA, and business stakeholders are essential to address issues proactively and ensure compliance in complex, regulated environments.

What is a Senior Computer System Validation (CSV) specialist?

A Senior Computer System Validation (CSV) specialist is an experienced professional responsible for ensuring that computer systems used in regulated industries—such as pharmaceuticals, biotechnology, or medical devices—meet compliance standards. This involves planning, executing, and documenting validation activities to demonstrate that systems consistently perform according to predefined specifications and regulatory requirements. Senior CSV specialists often lead validation projects, manage teams, and interact with regulatory auditors, making sure that systems are reliable, secure, and compliant with guidelines like FDA 21 CFR Part 11 and GxP. Their expertise helps organizations avoid compliance issues, data integrity problems, and costly system failures.
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Senior Computer System Validation Csv jobs near you
Infographic showing various Senior Computer System Validation Csv job openings in the United States as of July 2026, with employment types broken down into 1% As Needed, 85% Full Time, 12% Part Time, and 2% Contract. Highlights an 82% Physical, 1% Hybrid, and 17% Remote job distribution, with an average salary of $134,726 per year, or $64.8 per hour.
Senior Computer Systems Validation Engineer

Senior Computer Systems Validation Engineer

Vaxcyte

San Carlos, CA • On-site

Full-time

Posted 14 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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