Senior Validation Specialist

hace 3 días

Ciudad de México, Ciudad de México Novartis Farmacéutica A tiempo completo

About the Role

As a Senior Validation Specialist at Novartis, you will contribute to the improvement of local and simple business processes, products, services, and software through data analysis. You will engage with business representatives and support the appropriate DDIT teams and Functions to develop business requirements and deliver data-driven recommendations to improve efficiency and add value.

Key Responsibilities:

  • Participate in projects and operational changes to ensure that the creation of qualification documentation is in compliance with Novartis standards and procedures.
  • Create/Update the CSV deliverables for OT systems as per Novartis procedures.
  • Advise and direct site teams on industry best practices for the development of CSV protocols, including risk assessments, user requirements, functional specifications, and test qualifications.
  • 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.
  • Provide expertise and best practice on the use of the electronic validation and lifecycle management tool for commissioning/qualification activities.
  • Participate in CSV-related investigations and issue resolution, ensuring effective and timely remediation.
  • Collaborate with Quality Assurance and e-Compliance teams to ensure that CSV activities are in compliance with Novartis 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.
  • Certifications in CSV or related fields (e.g., GAMP 5, RAPS) are a plus.

Why Novartis: At Novartis, we're committed to helping people with diseases and their families. We're a community of smart, passionate people who collaborate, support, and inspire each other to achieve breakthroughs that change patients' lives.

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