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Principal Engineer – Device & Packaging Technical Launch Integrator

jj · Schaffhausen

New
Senior 🇬🇧 English
device assembly secondary packaging design transfer process validation equipment qualification risk assessment FMEA

Job description

About the role

Johnson & Johnson Innovative Medicine seeks a Principal Engineer to lead device and packaging technical integration for new product launches. You will work within the MSAT Biotherapeutics Platform, providing end‑to‑end technical leadership from design transfer through commercial launch.

Key responsibilities

  • Act as the technical lead for device and packaging projects, guiding global cross‑functional teams and representing MSAT in value‑chain discussions.
  • Lead design transfer, industrialization, scale‑up, qualification and validation of device assembly and packaging processes for commercial manufacturing.
  • Develop project plans, manage risks, and ensure launch readiness, including regulatory submission support and handover to operations.
  • Produce comprehensive technical documentation packages covering design transfer plans, risk assessments, FMEAs, specifications, equipment qualification and validation reports.

Required profile

  • Minimum 10 years of experience in device, packaging, manufacturing, technology transfer or related engineering roles, preferably in pharma or medical‑device industries.
  • Proven ability to lead complex, global, cross‑functional projects from initiation through commercial implementation.
  • Strong communication and stakeholder‑management skills, with the capacity to influence decisions without direct authority.

Required skills

  • Device assembly and secondary packaging processes
  • Design transfer and industrialization
  • Process validation and qualification (GMP)
  • Risk management tools such as FMEA
  • Regulatory and quality‑system requirements (Design Control, Change Control)

What we offer

  • Up to 40% remote work flexibility
  • International travel up to 10% for project support
  • Exposure to a global new‑product pipeline and opportunities for professional development

Questions fréquentes

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Source : ats:workday

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Published 4 hours ago

Expires 1 month from now

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jj

Schaffhausen