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Process Engineer Sequencing

ELAN Personal AG · Zug

New
Mid 🇬🇧 English
GxP Change control Non-conformity management KPI analysis DoE

Job description

About the role

ELAN Personal AG, acting for Roche Diagnostics International AG in Rotkreuz, is recruiting a Process Engineer Sequencing for the Sensor & Cartridge Operations (S&C) team. The team develops a Next-Generation Sequencing platform in its Research Use Only phase, built on CMOS sensor modules and sequencing-by-expansion nanopore technology. The role supports the ramp-up of a newly established production line.

Key responsibilities

  • Provide hands-on technical support to production operators and act as a Subject Matter Expert during the ramp-up of the new production line.
  • Drive continuous improvement initiatives to optimise yield and efficiency.
  • Create and maintain process documentation, change records and work instructions in line with GxP standards.
  • Handle non-conformity notifications, lead investigations and root-cause analyses, and coordinate corrective actions.
  • Monitor production data and analyse process performance indicators to ensure process stability and quality.
  • Coordinate with internal and external partners, including subject matter experts in Santa Clara, USA.

Required profile

  • Degree in natural sciences or engineering (e.g. biotechnology, biology, chemistry, materials science, mechanical/electrical engineering) or equivalent apprenticeship and professional experience.
  • 2-3 years of experience in a highly regulated environment with a strong quality and GxP mindset.
  • Fluent English and good German (B2+).

Required skills

  • Solid knowledge of non-conformity management, deviations, change control and technical documentation.
  • Hands-on experience troubleshooting manufacturing processes and supporting operators during ramp-ups.
  • Nice to have: technical supplier management, KPI analysis and DoE with statistical tools, and coaching skills.

What we offer

  • Work for a leading pharmaceutical company.
  • A modern campus with green spaces and meeting areas, close to the motorway and a train station.
  • A varied range of responsibilities in a squad of 6.
  • Very good compensation.

Questions fréquentes

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Published 6 hours ago

Expires 1 month from now

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ELAN Personal AG

Zug