Quality Assurance Engineer Validation Project Specialist

il y a 4 semaines

Rouen, Normandie, France Novo Nordisk AS Temps plein

Are you passionate about the pharmaceutical industry and eager to contribute to a global program involving multiple sites worldwide? Do you want to be part of a rapidly expanding company? If so, you might be the right fit for this role.

Our opportunity is based at the Chartres production site, which is undergoing a massive investment of 2.1 billion euros as part of a global program involving other sites worldwide.

The Position

As a Quality Assurance Engineer Validation Project Specialist, you will play a crucial role in ensuring the successful start-up of future production lines and associated equipment within specified timelines, adhering to Good Manufacturing Practices (GMP) and internal procedures.

You will have a cross-functional position, collaborating with various project departments such as aseptic production, finished product production, building and utilities, IT, warehouse and logistics, and quality control.

As an Engineer in Quality Assurance Project, your responsibilities will include:

  • Participation in different project stages, including defining user requirements, supplier selection and evaluation, equipment design validation, analysis of quality and regulatory risks, monitoring verification activities (FAT/SAT/IV/OV/PfV), and process validation.
  • Establishing and challenging qualification and validation strategies.
  • Building an effective communication network with central Quality Assurance and process teams (in Denmark), ensuring standardization of approaches and harmonizing work methods with other Novo Nordisk project entities worldwide (US, China, Brazil, Europe).
  • Maintaining the validated status of equipment/processes.
  • Preparing and ensuring the ramp-up (operational readiness) for Quality Assurance teams to guarantee a successful handover to operational teams.

In this role, you'll have the exciting opportunity to work on cutting-edge technologies, including:

  • AGV (Automated Guided Vehicles): Implementing advanced automated vehicles for efficient material handling.
  • Warehouse Automation: Utilizing state-of-the-art technologies for warehouse automation.
  • Isolator Filling with Ready-to-Use and Ready-to-Sterilize: Working on innovative filling processes under isolator conditions with ready-to-use and ready-to-sterilize solutions.
  • Environmental Cleaning Program with Robots: Contributing to environmental cleanliness through advanced cleaning programs involving robotic technologies.

Qualifications:

  • You have an engineering degree (BAC +5) or equivalent experience of at least 3-4 years in the pharmaceutical industry, specifically in the field of validation.
  • You have experience in the qualification and validation of equipment such as washers, autoclaves, filling lines under isolators, assembly and packaging, etc.
  • You have strong communication and persuasion skills, particularly in English in an international environment.
  • You enjoy working in a multicultural team (occasional travel may be required).

About The Department

As part of the "Fill and Finish Expansions" project, you will be connected to the Quality Assurance entity managing Novo Nordisk's entire investment project portfolio. You will play a key role in the extension project at the Chartres site, aiming to double production capacity by 2028-2030 to provide innovative treatments to an increasing number of patients.

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