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Computer Systems Validation Jobs in Texas (NOW HIRING)

Support cross-functional groups for QMS functions and projects not limited to Computer Systems Validation, Equipment Maintenance, Manufacturing, Quality Control, New Hire Onboarding, external and ...

Support cross-functional groups for QMS functions and projects not limited to Computer Systems Validation, Equipment Maintenance, Manufacturing, Quality Control, New Hire Onboarding, external and ...

Validation Engineer II

Houston, TX ยท On-site

$85 - $120/hr

Support cross-functional groups for QMS functions and projects not limited to Computer Systems Validation, Equipment Maintenance, Manufacturing, Quality Control, New Hire Onboarding, external and ...

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Computer Systems Validation information

What is computer systems validation?

Computer systems validation (CSV) is the process of ensuring that computer-based systems used in regulated industries, like pharmaceuticals and biotechnology, perform their intended functions consistently and reliably. This process involves documenting and testing systems to confirm they meet regulatory requirements, such as those set by the FDA. The goal is to ensure data integrity, product quality, and patient safety by minimizing the risk of system errors or failures. CSV typically includes activities like risk assessment, test planning, execution, and maintaining thorough records for audits.

What are the key skills and qualifications needed to thrive in computer systems validation, and why are they important?

To thrive in Computer Systems Validation, you need a solid understanding of regulatory requirements (such as FDA or EMA guidelines), software development life cycles, and risk management, often supported by a degree in life sciences, IT, or engineering. Experience with validation frameworks, documentation tools, and systems like GAMP 5 and knowledge of 21 CFR Part 11 compliance are typically required. Attention to detail, strong analytical thinking, and effective communication set professionals apart in this role. These skills and qualifications ensure validated systems are compliant, reliable, and support organizational quality and regulatory objectives.

What are some common challenges faced in a computer systems validation role, and how can they be addressed?

Professionals in Computer Systems Validation often encounter challenges such as keeping up with evolving regulatory requirements, managing documentation for multiple systems, and coordinating with cross-functional teams. Staying updated through regular training and industry resources helps address compliance changes. Clear communication and collaboration with IT, Quality Assurance, and business stakeholders are essential for efficient validation processes. Utilizing validation lifecycle management tools and standardized templates can also streamline documentation and reduce errors.

What is the difference between Computer Systems Validation vs Quality Assurance Specialist?

AspectComputer Systems ValidationQuality Assurance Specialist
CertificationsGAMP, CSV-specific trainingISO 9001, Six Sigma
Work EnvironmentRegulated industries like pharma, biotechManufacturing, software, service sectors
Primary FocusEnsuring computer systems meet regulatory standardsEnsuring overall product/service quality
Common UsageValidation of software, hardware in complianceProcess audits, quality improvement

Computer Systems Validation and Quality Assurance Specialist roles overlap in ensuring compliance and quality. However, CSV focuses specifically on validating computer systems to meet regulatory standards, especially in pharma and biotech industries. Quality Assurance Specialists have a broader scope, overseeing overall quality processes across various sectors. Both roles require similar certifications and work environments but differ in their primary objectives and specific tasks.

What are popular job titles related to Computer Systems Validation jobs in Texas?

For Computer Systems Validation jobs in Texas, the most frequently searched job titles are:

What cities in Texas are hiring for Computer Systems Validation jobs?

Cities in Texas with the most Computer Systems Validation job openings:

Infographic showing various Computer Systems Validation job openings in Texas as of August 2026, with employment types broken down into 1% As Needed, 86% Full Time, 9% Part Time, 3% Contract, and 1% Nights. Highlights an 88% Physical, 3% Hybrid, and 9% Remote job distribution.

Computer Systems Analyst

Prominds Business Consulting Inc

Frisco, TX โ€ข On-site

Other

Posted 5 days ago


Job description

Computer Systems Analyst

Employment Type: Full-Time/Permanent

Work Location: Frisco, Texas

The Computer Systems Analyst position is responsible for analyzing, evaluating, and improving computer-based information systems and related business processes. The position serves as a liaison between business stakeholders and technical teams to ensure that information systems effectively support operational and business objectives.

The Computer Systems Analyst will analyze business requirements, evaluate existing information systems, assess reporting and data requirements, identify opportunities for improvement, validate proposed solutions, and support the implementation and optimization of technology solutions.

The position is analytical in nature and focuses on information systems analysis, business process evaluation, requirements gathering, data analysis, system validation, reporting, and technology optimization.

PRIMARY RESPONSIBILITIES

The Computer Systems Analyst will perform the following responsibilities:

1. Analyze business processes and information systems to identify operational requirements, system gaps, process inefficiencies, and opportunities for technology and business process improvements.

2. Gather, analyze, document, and validate business and functional requirements by collaborating with business users, end users, project stakeholders, and technical teams.

3. Evaluate existing enterprise information systems and recommend enhancements designed to improve efficiency, data quality, reporting capabilities, system functionality, and user experience.

4. Develop and maintain functional and system documentation, including business requirements documentation, functional specifications, process documentation, workflow diagrams, reporting documentation, and related system requirements.

5. Analyze data and reporting requirements and evaluate reporting outputs to identify trends, operational issues, data quality concerns, and opportunities for process optimization.

6. Analyze business intelligence and reporting requirements and support reporting solutions utilizing technologies such as SQL, Microsoft Power BI, Microsoft Fabric, Azure-based platforms, and related enterprise reporting environments.

7. Perform data validation and analysis activities to evaluate information accuracy, consistency, and reliability and to support effective business reporting and decision-making.

8. Perform system testing, User Acceptance Testing (UAT), and validation activities to evaluate system enhancements, identify discrepancies, document results, and verify that implemented solutions satisfy documented business requirements.

9. Investigate system-related issues by analyzing system behavior, business processes, data, and reporting outputs and providing analytical recommendations to support resolution.

10. Collaborate with business stakeholders and technical teams during information system enhancement and implementation initiatives to clarify requirements, evaluate proposed changes, and support successful implementation.

11. Analyze proposed system changes and enhancements to evaluate their potential impact on business processes, reporting requirements, data environments, and existing information systems.

12. Develop and maintain reports, dashboards, and performance metrics to support business analysis, operational monitoring, and informed decision-making.

13. Monitor system performance and user feedback to identify improvement opportunities and recommend enhancements that improve operational efficiency, system effectiveness, and reporting capabilities.

14. Analyze business workflows and information flows across applications, databases, reporting environments, and related information systems to identify opportunities for integration and process improvement.

15. Support project planning and implementation activities by analyzing requirements, identifying dependencies, preparing documentation, and coordinating with business and technical stakeholders.

16. Stay current with developments in information technology, business intelligence, data analytics, enterprise applications, and related technologies in order to provide informed recommendations regarding information system improvements.

KNOWLEDGE AND QUALIFICATIONS REQUIRED

Successful performance of the Computer Systems Analyst position requires professional-level knowledge and analytical capability in:

  • Business systems analysis methodologies;
  • Business process analysis and evaluation;
  • Requirements gathering and functional documentation;
  • Information systems evaluation;
  • Data analysis and reporting concepts;
  • User Acceptance Testing (UAT) and system validation;
  • SQL and relational database concepts;
  • Business intelligence and reporting platforms, including Microsoft Power BI;
  • Cloud-based and enterprise technology environments;
  • Data validation and reporting analysis; and
  • Cross-functional collaboration with business and technical stakeholders.
  • Bachelor''s degree in Computer Science, Engineering, Information Systems, or a closely related technical discipline.
  • Professional experience in information systems analysis, enterprise applications, business intelligence, data analytics, reporting, requirements analysis, testing, or business-process improvement.
  • Ability to analyze business requirements and translate them into functional or system requirements.
  • Knowledge of relational databases, SQL, data analysis, reporting environments, and business-intelligence concepts.
  • Experience with or working knowledge of technologies such as Microsoft Power BI, Microsoft Fabric, Azure-based data/analytics services, and related enterprise reporting platforms.
  • Strong analytical, problem-solving, documentation, communication, and stakeholder-collaboration skills.