Process Engineer Sequencing

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.