Computer System Validation Specialist

6 days ago


Étreux, Hauts-de-France, United States Arrayo Full time
Arrayo is seeking a highly skilled Computer System Validation Lead to join our team. This role requires a seasoned professional with extensive experience in computerized system validation, particularly in the context of GCP, GVP, and GLP. As a leader in this field, you will be responsible for developing and executing compliant and nimble validation strategies for cloud-based clinical, regulatory, and safety applications.

Key Responsibilities:
  • Define overall validation strategy and approach for Digital Clinical CSV projects, aligning with QA policies and best practices.
  • Author key validation documents, including Validation Plans, Validation Summary reports, and Test Plans.
  • Advise project and technology teams on validation and data integrity best practices and approaches.
  • Collaborate with GCP QA on process definition and improvement, authoring and revising CSV-related SOPs.
  • Coordinate with external Vendors on Validation and IT operations support tasks.
  • Coordinate CSV activities (UAT, document reviews) for clinical digital projects.
  • Liaise with GMP CSV team to harmonize and streamline validation practices.
  • Provide training on validation process and templates.
  • Oversee CSV readiness for inspections and audits, supporting QA and business teams during inspection activities.

Requirements:
  • 10+ years of computerized system validation experience with a primary focus on GCP, GVP, and GLP.
  • 5+ years of validation team leadership, providing coaching, mentoring, and coordinating validation efforts within larger projects.
  • Proven experience in leading sustainable and nimble validation efforts for SaaS/PaaS GxP systems and cloud infrastructure.
  • Working knowledge of CSV, data integrity, and ICH guidance related to computerized systems in clinical trials.
  • Solid project management skills.
  • Experience with Veeva platforms is a major plus.
  • Extensive hands-on work with Validating GxP platforms such as RIM, QMS, and SAS.
  • High-level experience with RIM processes.
  • Experience supporting regulatory inspections related to computerized systems.
  • Excellent communication skills.
  • Demonstrated experience in authoring key validation deliverables.
  • Experience with paperless validation preferred.
  • Bachelor's degree in computer science, biotechnology, engineering, or equivalent.


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