Computer System Validation Engineer Job at Katalyst HealthCares & Life Sciences, Princeton, NJ

  • Katalyst HealthCares & Life Sciences
  • Princeton, NJ

Job Description

Job Title

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.

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