Computer System Validation Engineer - Data Integrity & GxP

Creative Solutions Services, LLC; Phoenix (AZ); On-site; USD 85,000 - 125,000; Full time

Job summary

Creative Solutions Services, LLC seeks a validation-focused professional to ensure computerized systems meet quality standards and regulatory requirements. The role emphasizes data integrity, lifecycle management, and cross-functional collaboration to improve operational efficiency.

You will validate hardware and software, develop documentation, and ensure testing strategies align with ALCOA principles, while supporting change control and data governance initiatives.

Qualifications

• Experience in validation, IT quality assurance, biomanufacturing or regulatory operations.
• Hands-on validation of computerized systems.
• Strong knowledge of pharma data integrity and regulatory guidance.
• Ability to work in a dynamic cross-functional team.

Responsibilities

• Apply quality standards and cGMP to validate systems and training.
• Align validation with ALCOA data integrity principles and testing.
• Facilitate risk assessments to identify deliverables and needs.
• Collaborate to optimize change management and backup policies.
• Develop validation documentation: requirements, UAT, SOPs, reports.
• Analyze validation data and troubleshoot with technical teams.
• Maintain stakeholder communication on validation progress.

Skills

Quality assurance

Validation

Data governance

Risk assessment

Data visualization

Regulatory compliance

Cross-functional teamwork

Education

Bachelor's degree in related field

Tools

UPLC

HPLC

HIAC

qPCR

NanoDrop

TOC Analyzer

Osmometer

Cell Counters

Excel

Job description

Creative Solutions Services, LLC seeks a validation-focused professional to ensure computerized systems meet quality standards and regulatory requirements. The role emphasizes data integrity, lifecycle management, and cross-functional collaboration to improve operational efficiency.

You will validate hardware and software, develop documentation, and ensure testing strategies align with ALCOA principles, while supporting change control and data governance initiatives.