Computer System Validation Engineer

About the Role

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.