Senior Device Manager
Novartis Farmacéutica, S.A.
Barcelona, Spain
hace 5 días

Job Description

Technical Steward Devices & Combination Products .

70+ billion! That’s the number of units Novartis Technical Operations (NTO) supplied to over countries in . Our 26,+ associates from different countries are working hard to build an inspired, curious and unbossed culture in which everyone is enabled to be their best.

We are unleashing the power of our people and putting data and digital at the heart of our transformation that is enabling us to reach more patients, on time, across the world.

Efficient and collaborative partnering and management of third party operations is of critical importance for continued Novartis’ success.

Do you want to be part of the team?

Your responsibilities include, but not limited to :

  • Owning the knowledge of specific medical device manufacturing process technologies, locally, including any pilot scale, scale up or down, and Design of Experiments
  • Providing and assuring the fundamental knowledge in the specific area of expertise through the provision of regular training and education programs for Process Experts and Operators
  • Providing technical leadership of Medical Device & Combination Products and validation across late stages of development through product end of life
  • Being the SME for specific Technology Platform or medical device processes following process product / process transfer or handover from launch to commercial production
  • Spearheading operational excellence strategies to improve combination product quality, reliability and reduce risk
  • Being responsible for drug / device combination stewardship including maintenance of technical documentation files, human factors files, risk management file, change control and support of regulatory filings and combination products pre-launch and post-launch
  • Collaborating with technical development, other sites and global MS&T network to facilitate transfer of technical knowledge
  • Performing technical feasibility trials related to process improvement and implementation of new manufacturing technologies
  • Minimum requirements

    What you’ll bring to the role :

  • Bachelors / Masters in Mechanical Engineering, Chemical Engineering or similar subject
  • Around 10 years of experience in combination products development or operations
  • Previous experience in pharmaceutical and biotechnology environment
  • Strong working knowledge of GMP manufacturing
  • Previous experience in outsourcing and strategic device partners
  • Project management experience in combination products
  • Fluency in English is essential written and spoken
  • You’ll receive : Company Pension Plan; Life and Accidental Insurance; Meals Allowance or Canteen in the office; Flexible working hours

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