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Computer System Validation Csv Pharmaceutical Jobs in Texas

Spruce Infotech

Validation Expert

Fort Worth, TX · On-site

Understanding of key pharmaceutical compliance regulations like Computerized System Validation, 21 ... the required Computer System Validation (CSV) Lifecycle Deliverables, quality gates and ...

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Computer System Validation Csv Pharmaceutical information

What is computer system validation (CSV) in the pharmaceutical industry?

Computer System Validation (CSV) in the pharmaceutical industry is a process used to ensure that computerized systems used in drug manufacturing and related processes work as intended and comply with regulatory standards, such as FDA 21 CFR Part 11. CSV involves planning, testing, documenting, and maintaining systems to guarantee the accuracy, reliability, and integrity of data. This is critical for patient safety and product quality, as well as for meeting legal and regulatory requirements. The process typically includes risk assessment, validation planning, protocol execution, and ongoing monitoring of system performance.

What are common challenges faced by computer system validation (CSV) professionals in the pharmaceutical industry?

CSV professionals in the pharmaceutical industry often encounter challenges such as keeping up with evolving regulatory requirements, managing documentation for audits, and ensuring thorough validation of complex systems within tight project timelines. Collaboration with cross-functional teams, such as IT, quality assurance, and manufacturing, is essential to address technical and compliance issues. Additionally, balancing the need for robust validation with operational efficiency requires strong communication and project management skills.

What are the key skills and qualifications needed to thrive as a computer system validation (CSV) professional in the pharmaceutical industry?

To thrive as a Computer System Validation (CSV) professional in pharmaceuticals, you need a strong background in life sciences or engineering, knowledge of regulatory standards (such as FDA 21 CFR Part 11), and experience with validation protocols. Familiarity with validation lifecycle management tools, quality management systems (QMS), and industry guidelines like GAMP 5 is typically required, along with certifications such as ISPE or PMP being advantageous. Outstanding attention to detail, analytical thinking, and strong communication skills help ensure compliance and effective coordination with cross-functional teams. These competencies are vital for maintaining regulatory compliance, data integrity, and patient safety in pharmaceutical operations.

What is the difference between Computer System Validation Csv Pharmaceutical vs Quality Assurance Specialist?

AspectComputer System Validation Csv PharmaceuticalQuality Assurance Specialist
CertificationsGxP, 21 CFR Part 11, Validation certificationsGxP, ISO, QA certifications
Work EnvironmentPharmaceutical manufacturing, regulated labsQuality departments across industries, including pharma
Employer & IndustryPharmaceutical companies, biotech firmsPharma, biotech, healthcare organizations
Primary FocusEnsuring computer systems meet validation and compliance standardsMaintaining quality standards and process improvements

Computer System Validation Csv Pharmaceutical specialists focus on validating computer systems to ensure compliance with industry regulations, while Quality Assurance Specialists oversee overall quality processes. Both roles require GxP knowledge and are vital in pharmaceutical environments, but their core responsibilities differ in scope and focus.

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Cities in Texas with the most Computer System Validation Csv Pharmaceutical job openings:

Computer System Validation Csv Pharmaceutical jobs near you
Infographic showing various Computer System Validation Csv Pharmaceutical job openings in Texas as of August 2026, with employment types broken down into 33% Full Time, and 67% Contract. Highlights an 100% In-person job distribution.

Senior CSV Engineer

Katalyst Healthcares and Lifesciences

Austin, TX • On-site

$103K - $142K/yr

Other

Posted 2 days ago

New

Job description

Job Description:
The Senior Computer System Validation (CSV) Engineer is responsible for leading validation activities for computerized systems used in regulated environments such as pharmaceutical, biotechnology, or medical device manufacturing. This role ensures that systems including LIMS, ERP, MES, and laboratory applications are validated in compliance with FDA, EU, and global regulatory requirements. The Senior CSV Engineer will act as a subject matter expert (SME), providing guidance on validation strategy, risk-based approaches, and regulatory compliance across the system lifecycle.
Responsibilities:
  • Lead and execute computer system validation (CSV) activities for GxP-regulated systems.
  • Develop and review validation deliverables including validation plans, URS, FS, DS, risk assessments, IQ/OQ/PQ protocols, and summary reports.
  • Ensure compliance with FDA 21 CFR Part 11, EU Annex 11, GAMP 5, and GxP regulations.
  • Define and implement risk-based validation strategies for computerized systems.
  • Oversee validation of systems such as LIMS, ELN, MES, ERP, CDS, and laboratory systems.
  • Support system implementations, upgrades, and decommissioning activities from a validation perspective.
  • Collaborate with IT, QA, Engineering, and business stakeholders to ensure compliant system deployment.
  • Lead change control assessments and determine validation impact of system changes.
  • Ensure data integrity (ALCOA+) compliance across validated systems.
  • Support audits and regulatory inspections by providing validation documentation and system justification.
  • Mentor and guide junior CSV engineers and validation team members.
  • Drive continuous improvement of validation processes, templates, and standards.
  • Review vendor documentation and ensure systems meet regulatory expectations prior to deployment.
Requirements:
  • Bachelor's degree in Engineering, Computer Science, Life Sciences, or related field.
  • 5-10+ years of experience in Computer System Validation (CSV) or validation engineering.
  • Strong experience in GxP-regulated pharmaceutical, biotech, or medical device environments.
  • Hands-on experience with validation of LIMS, MES, ERP, or laboratory systems.
  • Strong knowledge of 21 CFR Part 11, EU Annex 11, and GAMP 5 guidelines.
  • Experience authoring and executing IQ/OQ/PQ protocols and validation documentation.
  • Strong understanding of risk-based validation and data integrity principles.
  • Experience supporting regulatory audits and inspections.
Preferred Skills:
  • Experience with systems such as LabWare, SAP, Oracle, Veeva, TrackWise, Empower.
  • Knowledge of cloud-based validation and SaaS systems.
  • Experience in data integrity remediation projects.
  • Strong technical writing and documentation skills.
  • bility to lead cross-functional validation projects.
Key Competencies:
  • Strong leadership and SME-level expertise in CSV.
  • Excellent analytical and risk assessment skills.
  • Strong communication and stakeholder management.
  • bility to manage multiple validation projects simultaneously.
  • High attention to detail and regulatory compliance mindset.

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