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RORoche

Group Lead Device Process Engineering - Global MSAT(m/w/x)

Basel
Full-timeOn-siteSenior

Global MSAT process engineering strategy at a leading diagnostics company. Strategic and technically credible leadership required. 4-day work week, company car for private use.

Requirements

  • Strategic and technically credible leadership
  • Ability to explain complex validation decisions
  • Translating technical risks into business impacts
  • Dedicated coach and talent developer
  • Setting high standards for technical rigor
  • Empowering team members
  • Effective communicator and resilient collaborator
  • Building trust across matrixed organizations
  • Focus on shared objectives during ambiguity
  • Degree in Mechanical Engineering, Pharmaceutical Engineering, or related technical field
  • Proven formal people leadership
  • Influencing across global matrixed organization
  • Deep expertise in device assembly
  • Deep expertise in packaging
  • Deep expertise in sterilization
  • Deep expertise in automated manufacturing
  • Strong knowledge of design controls
  • Strong knowledge of risk management (ISO 14971)
  • Strong knowledge of DfM
  • Strong knowledge of technical transfer processes
  • Experience with global external manufacturing partners
  • Experience with global supplier networks

Tasks

  • Lead and develop a high-performing team of process engineers
  • Set clear expectations for technical excellence and functional capability
  • Define and drive the global process-engineering strategy
  • Act as the senior technical authority for complex engineering decisions
  • Balance quality, compliance, supply, and speed-to-market
  • Drive structured process characterization using DOE and statistical tools
  • Identify critical process parameters and material attributes
  • Establish robust control strategies
  • Translate design outputs into production specifications
  • Define equipment requirements and manufacturing work instructions
  • Govern risk-based validation strategies for manufacturing processes
  • Qualify equipment and manage sterilization processes
  • Manage the process-engineering framework for continued verification
  • Support process investigations and lifecycle optimization
  • Ensure compliance with global regulatory requirements

Work Experience

  • 12 - 15 years

Education

  • Bachelor's degree

Languages

  • EnglishBusiness Fluent

Tools & Technologies

  • ISO 14971
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Roche and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.

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