Process Engineer- Sequencing

Process Engineer- Sequencing: Scaling / Stabilizing complex, automated production lines / GxP documentation / NC) management / Deviations / Change Control/ Continuous Improvement / Technical Supplier Management /English / Deutsch

Background:

Roche Sequencing systems represent a crucial frontier in diagnostics-delivering advanced genomic insights that are critical for personalized healthcare and patient welfare. Within the technology area Sensor & Cartridge Operations (S&C), we focus on cutting-edge Next-Generation Sequencing platforms. Our team proudly works on a highly innovative, revolutionary product currently in its Research Use Only (RUO) phase, which has been developed in the USA and is being manufactured in Rotkreuz (Switzerland). This product leverages breakthrough complementary metal-oxide-semiconductor (CMOS) sensor modules and sequencing by expansion (SBX) nanopore technology to fundamentally transform genomics.

The Perfect Candidate is a hands-on technical engineer with an engineering degree (mechanical, mechatronics, automation, or micro-technology) and around 2-5 years of experience scaling and stabilizing complex, automated production lines. They thrive on the shop floor working directly with high-precision assembly, dispensing, robotics, and machine protocols. Outgoing and communicative in both German and English, they serve as the vital bridge between R&D designs and daily line operations, taking contradictory technical inputs, finding the root cause of physical line issues, designing practical tests (DoE), and implementing robust equipment upgrades and standard GxP documentation

Tasks & Responsibilities:

• Shopfloor Support & SME Role: Provide direct, hands-on technical support for daily production operations. Act as a Subject Matter Expert (SME) to support production operators during the exciting ramp-up phase of our newly established production line. Proactively drive Continuous Improvement initiatives to optimize yield and efficiency.
• Document & Change Management: Create and maintain robust process documentation, change records, and work instructions in line with GxP standards.
• Product Care & NC Management: Take ownership of product care activities within the Squad. This includes handling non-conformity notifications, leading structured investigations and root-cause analyses, and coordinating corrective actions in the manufacturing process.
• Data-Driven Process Monitoring: Monitor production data and analyze production and process performance indicators to ensure process stability and high quality.
• Global Collaboration & Coordination: Coordinate and collaborate closely with internal and external partners, including exchange with subject matter experts in Santa Clara, USA.
• Note: This requires flexibility regarding working hours for occasional evening meetings due to time zones.
• Regulatory Compliance: Work strictly according to internal processes defined by our GxP-regulated environment.

Must Haves:

• You bring a University degree in Natural Sciences or Engineering ( , Biotechnology, Biology, Chemistry, Molecular Biology, Material Science, Mechanical/Electrical Engineering) and/or a completed apprenticeship with equivalent professional experience in a related field
• You bring proven professional experience (2-3 years) within a highly regulated environment, backed by a strong quality awareness (GxP mindset)
• You bring a solid foundation in non-conformity (NC) management, deviations, change control, and technical documentation
• You bring direct experience troubleshooting manufacturing operations and partnering closely with operators during production ramp-up
• You bring high motivation for teamwork, excellent communication skills, and the ability to work independently within and across multi-disciplinary teams
• You bring enthusiasm for taking on responsibility and proactively collaborating with a highly engaged team of engineers, operators, QA, and logistics.
• You bring a genuine interest in learning manufacturing technologies and continuously improving diverse sequencing processes to support our in-house production efficiently
• You bring fluent communication skills in English and a good working knowledge of German (B2+)

Nice to Haves:

• Proven experience in Technical Supplier Management (TSM) or similar roles, with a strong focus on managing supplier relations, changes and driving general technical or process change initiatives.
• Experience in data-driven process monitoring and the ability to analyze key production performance indicators.
• Practical knowledge in planning and executing experiments, ideally utilizing statistical tools like Design of Experime j4id10478201tt j4it1146tt j4iy26tt