Computer System Validation Engineer - Data Integrity & GxP

Katalyst-Healthcares-; Phoenix (AZ); Sur place; USD 85 000 - 125 000; Plein temps

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

Quality assurance

Validation

Data governance

Risk assessment

Data visualization

Regulatory compliance

Cross-functional teamwork

Formation

Bachelor's degree in related field

Outils

UPLC

HPLC

HIAC

qPCR

NanoDrop

TOC Analyzer

Osmometer

Cell Counters

Excel

Description du poste

Job Description:

• In this role, you will collaborate with cross-functional teams to ensure systems meet quality standards and regulatory requirements through a risk-based approach. This position focuses on maintaining data integrity and system lifecycle management while contributing to operational efficiency.

Responsibilities:

• Apply quality standards and cGMP requirements to validate computer systems, including hardware, software, procedures, and training.
• Ensure system validation aligns with Data Integrity principles (ALCOA) and includes appropriate testing strategies.
• Facilitate risk assessments to identify validation deliverables and project requirements.
• Collaborate with Quality Assurance and other teams to optimize processes such as change management, backup policies, configuration management, and periodic reviews.
• Develop and execute validation documentation, including requirements, user acceptance testing, SOPs, system impact assessments, traceability matrices, protocols, and reports.
• Analyze validation data and troubleshoot issues in collaboration with technical teams.
• Maintain communication with stakeholders to address system needs, validation progress, and related concerns.

Requirements:

• Experience in validation, IT quality assurance, quality control, biomanufacturing, clinical, or regulatory operations.
• Hands-on experience in validating computerized systems.
• Strong understanding of pharmaceutical industry regulatory compliance, particularly US and EU/MHRA data integrity guidance.
• Ability to work effectively in a dynamic, cross-functional team environment.
• Proven expertise in applying data governance measures and creating impactful data visualizations.
• Preferred experience with tools and systems such as UPLC, HPLC, HIAC, qPCR, NanoDrop, TOC Analyzer, Osmometer, Cell Counters, and Excel spreadsheet validation.
• Bachelor's degree in computer science, Engineering, Biological Sciences, or a related field.