Computer System Validation Engineer

Keep the heartbeat of innovation running! Join our client in this engineering position and ensure cutting-edge validation engineering never misses a beat! Proclinical is seeking a Computer System Validation Engineer to support the validation and compliance of GxP computer systems.

Responsibilities

Collaborate with cross-functional teams to ensure systems meet quality standards and regulatory requirements through a risk-based approach; Focus on maintaining data integrity and system lifecycle management while contributing to operational efficiency; 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; Bachelor's degree in Computer Science, Engineering, Biological Sciences, or a related field

Nice to have

Preferred experience with tools and systems such as UPLC, HPLC, HIAC, qPCR, NanoDrop, TOC Analyzer, Osmometer, Cell Counters, and Excel spreadsheet validation