Sr. Specialist Qualification Engineer

Major accountabilities:

• • Participate in projects and operational changes to ensure that the creation of the 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 the 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
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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)

Minimum Requirements:
Work Experience:

• • 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.