Senior Specialist Qualification Engineer

hace 4 semanas


Xico, México Advanced Accelerator Applications (Italy) - S... A tiempo completo

Job Summary

We are seeking a highly skilled Senior Specialist Qualification Engineer to join our team at Advanced Accelerator Applications (Italy) - S.p.A. The ideal candidate will have a strong background in computer system validation, process automation systems, and regulatory requirements.

Key Responsibilities

  • Contribute to the improvement of business processes, products, and services through data analysis and collaboration with business representatives.
  • Develop and deliver data-driven recommendations to improve efficiency and add value.
  • Participate in projects and operational changes to ensure compliance with company standards and procedures.
  • Advise and direct site teams on industry best practices for the development of CSV protocols.
  • Engage with the in-house service of qualification engineers/technical writers to ensure consistency of documentation and compliance.
  • Provide test management for the execution of qualification activities.
  • Collaborate with Quality Assurance and e-Compliance teams to ensure CSV activities are in compliance with company procedures.
  • Act as a data quality checker of the Master Equipment Inventory of all sites.

Requirements

  • Bachelor's degree in Computer Science, Engineering, or a related field. Master's degree preferred.
  • Minimum of 10 years of experience in computer system validation, with a focus on process automation systems.
  • In-depth knowledge of regulatory requirements (e.g., FDA, GxP, 21 CFR Part 11) and industry best practices related to CSV.
  • Strong understanding of software development lifecycle methodologies and their application to CSV activities.
  • Excellent problem-solving and analytical skills, with the ability to identify and resolve complex CSV issues.
  • Strong communication and interpersonal skills, with the ability to effectively collaborate with cross-functional teams and stakeholders at all levels of the organization.
  • Detail-oriented mindset, with a focus on accuracy and compliance.
  • Ability to work independently, prioritize tasks, and meet deadlines in a fast-paced environment.

Why Join Us

At Advanced Accelerator Applications (Italy) - S.p.A., we are committed to helping people with disease and their families. We believe in the importance of collaboration, support, and inspiration among our team members. If you are a motivated and skilled professional looking to make a difference, we encourage you to apply for this exciting opportunity.



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