Computer System Validation Engineer

Computer System Validation Engineer - Contract - Cranbury, NJ. Join a team where your validation expertise will help safeguard the systems and data that support the development of life-changing therapies. Proclinical is seeking a Computer System Validation Engineer to support the validation and compliance of GxP computer systems. This position focuses on applying a risk-based approach to validation activities while adhering to regulatory standards.

Responsibilities

Collaborate with cross-functional teams to ensure data integrity and system quality throughout the entire lifecycle; Apply quality standards and cGMP requirements to validate computer systems, including hardware, software, procedures, and training; Ensure validation strategies align with Data Integrity principles (ALCOA) and include appropriate testing methodologies; Facilitate risk assessments to identify validation deliverables and project requirements; Collaborate with Quality Assurance and other teams to optimize operational 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, project status, and validation updates

Requirements

Experience in validation, IT quality assurance, quality control, biomanufacturing, clinical, or regulatory operations; Direct 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 cross-functional, fast-paced environment; Proven success in implementing data governance measures; Strong communication skills, including the ability to present data and visualizations persuasively; Bachelor's degree in Computer Science, Engineering, Biological Science, or a related field

Nice to have

Preferred experience with UPLC; HPLC; HIAC; qPCR; NanoDrop; TOC Analyzer; Osmometer; Cell Counters; Familiarity with Excel spreadsheet validation