S&C MSAT Process Engineer (m/f/d)

S&C MSAT Process Engineer (m/f/d) - GMP / QA / Logistics / English / German

Project:
For our customer Roche Diagnostics International AG based in Rotkreuz we are looking for a qualified S&C MSAT Process Engineer (m/f/d)S&C MSAT Process Engineer (m/f/d)

S&C MSAT Process Engineer (m/f/d) - GMP /QA / Logistics / English / German

Project:
For our customer Roche Diagnostics International AG based in Rotkreuz we are looking for a qualified S&C MSAT Process Engineer (m/f/d)

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 (NGS) platforms. Our team proudly works on a highly innovative, revolutionary product currently in its Research Use Only (RUO) phase, which is being manufactured in parallel across two global sites: Santa Clara (USA) and Rotkreuz (Switzerland). This product leverages breakthrough complementary metal-oxide- semiconductor (CMOS) sensor modules and sequencing by expansion (SBX) nanopore technology to fundamentally transform genomics.

As an MSAT Process Engineer (PE), you will have a direct impact on and bring value to our patients and customers. Supported by your squad and PE team, you will start with core compliance tasks-such as non-conformity, change, and document management-and

continuously grow in your role, taking on increased responsibility for products and processes.

For our team in Rotkreuz, we are looking for an experienced engineer to provide technical support for our newly built sequencing production in daily business as well as in improvement projects within a matrix structure. If you have a background in a regulated

environment, a knack for compliance, a big-picture mindset, and thrive in a fast-paced, agile environment where no two days are the same, you will fit right in!

The Perfect Candidate holds a university degree in natural sciences or engineering-or possesses an equivalent professional apprenticeship-with 1 to 3 years of experience in a highly regulated environment and a strong commitment to quality standards (GxP mindset). They are a collaborative, proactive individual with excellent communication skills, capable of working effectively both independently and within multi-disciplinary teams. Furthermore, the role requires an enthusiasm for learning new manufacturing technologies, an interest in continuous process improvement, and fluency in English alongside a working knowledge of German (B2+).

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
• Change Management: Initiate, drive, and implement technical and process changes within SAP for our sequencing sensors and cartridges
• 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 our parallel site 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

Future Outlook (Transitioning into 2027):

• Process Optimization & CIP: Proactively drive Continuous Improvement Process (CIP) initiatives within the sensor production line using Lean & Six Sigma methodologies to optimize yield and efficiency.
• Technical Supplier Management (TSM): Gradually take over the technical relationships with external suppliers to secure our global supply chain

Must Haves:

• 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 (****)
• 1-3 years proven professional experience within a highly regulated environment, backed by a strong quality awareness (GxP mindset) (****) j4id10304834a j4it0729a j4iy26a