Senior Life Science Consultant

hace 6 días


Sevilla, Sevilla, España Johnson & Johnson A tiempo completo
Senior Life Science Consultant

We are seeking a highly skilled and motivated senior CSV consultant with expertise in AI to join our team.

Key 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.
  • 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.
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 a 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.
  • Excellent remuneration package consisting of a competitive salary plus a substantial bonus.


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