Senior Specialist Qualification Engineer

hace 4 días


Victoria de Durango, Durango, México Novartis Farmacéutica A tiempo completo
About the Role

**Job Summary**

We are seeking a highly skilled Senior Specialist Qualification Engineer to join our team at Novartis Farmacéutica. As a key member of our organization, you will play a critical role in ensuring the quality and compliance of our computerized systems.

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.

Key Performance Indicators

  • Feedback on dedicated phases for Project execution (quality, time) - Degree of customization vs configuration of COTS solutions.
  • Process efficiency (specific scope) - Steady/Uninterrupted process flow (specific scope) - Completeness and accuracy of Business Process Model (BPM) - local or non-complex processes - Business process documentation up to date (specific scope).

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.


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