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Senior Life Science Consultant

1 mese fa

Pescara, Abruzzo, Italia Johnson & Johnson A tempo pieno
Job Overview

We are seeking a highly skilled and motivated senior CSV consultant with expertise in AI to join our team. The ideal candidate should have proven experience with system development, lifecycles, computer system validation, and regulatory standards. Additionally, the candidate should possess extensive knowledge in AL solutions, including the utilization of Open AI technologies like ChatGPT, and demonstrate the ability to develop robust testing strategies for these systems.

Responsibilities
  • Providing consultation services to our clients in the pharmaceutical industry, with a specific focus on computer system validation (CSV) and AI solutions
  • Develop, implement, and maintain AI solutions using technologies like Open AI's ChatGPT.
  • Feed internal procedures & documents into AI systems, ensuring the system accurately identifies the source.
  • Deliver insights on regulatory differences across various countries and present these findings through clear and concise reports and graphical representations.
  • Develop and execute validation deliverables, including requirements, compliance/validation plans, test protocols, test summary reports, and compliance/validation reports.
  • Review and approve system tests, user acceptance test scripts, traceability matrices, and design specifications.
  • Design and understand test plans, system, and UAT test scripts, and test procedures for AI solutions.
  • Provide guidance on validation, conduct timely reviews, and escalate to TQ management when necessary.

Requirements
  • Bachelor's degree in computer science, Data Science, or a related field.
  • Master's degree is preferred.
  • Fluent in English (oral and written) is a requirement.
  • Any additional language is plus.
  • 3+ years of experience in Computer System Validation.
  • 2+ years of experience with System development Lifecycle.
  • Prior experience in the Pharmaceutical, Biotechnology, or Medical Device industry.
  • Familiarity with FDA regulations and global regulatory environments.
  • Understanding of GxP standards and risk-based validation.

What We Offer
  • Flat hierarchies and responsibility from the beginning
  • People-oriented culture
  • Diversity and inclusion-focused environment
  • Global client projects in a multinational environment
  • Flexible working hours and home office
  • Involvement in global conferences
  • Individual professional development, training, and coaching
  • Unlimited full employment contract
  • Excellent remuneration package consisting of a competitive salary plus a substantial bonus.