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Senior Computer System Validation Csv Jobs in Texas

Spruce Infotech

Validation Expert

Fort Worth, TX · On-site

Work with project management to build an integrated project plan inclusive of the required Computer System Validation (CSV) Lifecycle Deliverables, quality gates and summarization milestones.

Graphcore

Senior System Validation Engineer

Austin, TX · On-site

Job Summary We are seeking a Senior System Validation Engineer to design and implement validation tests for Arm-based data center SoCs using a combination of open-source benchmarking tools and custom ...

Graphcore

Senior System Validation Engineer

Austin, TX · Hybrid

Job Summary We are seeking a Senior System Validation Engineer to design and implement validation tests for Arm-based data center SoCs using a combination of open-source benchmarking tools and custom ...

Stellantis

Senior System Validation Engineer DUTIES: Validating complex embedded software interactions ... Bachelor's degree (or foreign equivalent) in Computer Science, Computer Engineering or related ...

Stellantis

Senior System Validation Engineer DUTIES: Validating complex embedded software interactions ... Bachelor's degree (or foreign equivalent) in Computer Science, Computer Engineering or related ...

Stellantis

Senior System Validation Engineer DUTIES: Validating complex embedded software interactions ... Bachelor's degree (or foreign equivalent) in Computer Science, Computer Engineering or related ...

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Senior Computer System Validation Csv information

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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Infographic showing various Senior Computer System Validation Csv job openings in Texas as of July 2026, with employment types broken down into 100% Full Time. Highlights an 100% In-person job distribution.

Validation Expert

Spruce Infotech

Fort Worth, TX • On-site

Contractor

Re-posted 8 days ago

Job description

We are looking for people who have demonstrated proven success in roles and through abilities in Computerized System Validation for R&D applications, Risk management and Quality Management.
  • 15+ yrs of professional experience in Life Sciences industry working for a consulting services organization and/or industry experience.
  • Understanding of key pharmaceutical compliance regulations like Computerized System Validation, 21 CFR Part 11, GxP, GAMP 5, Data Privacy, Data Integrity and Information Security
  • Develop and document the validation strategy and approach for the Software Development Lifecycle Activities (SDLC) for the global implementation of R&D systems considering GxP & Non GxP elements and recommend for risk-based testing approach as required.
  • Work with Client Q&C to ensure system compliance with internal policies, procedures, guidelines, and applicable health authority regulations and provide improvement plan to streamline practices, and revise CSV related SOPs as necessary.
  • Work with project management to build an integrated project plan inclusive of the required Computer System Validation (CSV) Lifecycle Deliverables, quality gates and summarization milestones.
  • Knowledge on basic functions on R&D systems
  • Knowledge of various tools/applications like JIRA, HP ALM, Qtest
  • Successful track record using Lean/Agile approaches to validate assets
  • Proven ability in handling multiple large projects, respond quickly to changing situations in complex environments

Preferable IT background to understand larger impact of architecture / technical complexities on the program

Apply