Product Engineering Expert (Manufacturing)

In this highly specialized permanent, full-time role as Senior Specialist - Tech Transfer & Manufacturing Science (SBX Sequencing) within the DODINL Production Laboratory & QC line organisation led by Eric Wanko, you will be the key technical anchor for the critical technology transfer of advanced genetic sequencing workflows. As part of Roche's global Dual-Site Strategy, we are expanding our manufacturing footprint to establish parallel production capabilities, where this transfer to Rotkreuz, Switzerland, is designed to complement and work in tandem with our existing operations in Santa Clara, USA, ensuring long-term global supply security and scaling our production capacity across both key sites. In this position, you will act as the ultimate Subject Matter Expert (SME) for the technical execution, optimization, and scaling of our proprietary sequencing consumable portfolios in Europe, leveraging your deep, pre-existing technical knowledge of our US-developed manufacturing lines to ensure seamless cross-site standardization as a central part of a genius team and shaping role.

The Opportunity

• Technology Transfer & Site Alignment: Drive the technical transfer of RUO (Research Use Only) and regulated genetic sequencing workflows (specifically SBX sequencing chemistry) from Roche Santa Clara (US) to the Rotkreuz site, ensuring absolute process alignment between both operating sites.
• Subject Matter Expert (SME): Serve as the primary technical authority for drafting, reviewing, and auditing site-specific operating procedures (SOPs), batch record templates, and work instructions for critical consumable components.
• Process Optimization & Scaling: Manage and execute complex experiments throughout the product lifecycle, from initial feasibility and stability testing through to official launch and routine manufacturing transfer.
• Advanced Quality Control: Oversee high-priority investigations into complex process failures or manufacturing deviations, applying advanced statistical techniques and data analysis to implement robust Corrective and Preventive Actions (CAPA).
• Cross-Functional Training: Translate development workflows into standardized work procedures, providing deep technical guidance and training local operators on complex reagent handling, raw material formulation, automated dispensing, and data analyzation.
• End-to-End Quality Inspection: Act as the final technical gatekeeper for complex diagnostic portfolios, ensuring strict adherence to compliance standards, including final inspections of specialized testing frameworks.

• Regulated Industry Expert: Seasoned scientist with comprehensive experience driving operations within strict cGMP, ISO 13485, and QSR-compliant biotech and molecular diagnostics environments.
• End-to-End Quality Mindset: Proven track record in executing rigorous in-process quality control (QC), raw material stability testing, and final product inspections to ensure total regulatory compliance.
• Analytical Problem Solver: Highly skilled in managing nonconformances and deviations, utilizing data-driven root-cause analysis to implement effective corrective and preventive actions (CAPA).
• Process & Efficiency Optimizer: Demonstrated success in process improvement and technology transfer projects, with a history of leveraging ERP systems (SAP) to measurably reduce production timelines and costs.
• Documentation & Compliance Anchor: Expert in the end-to-end lifecycle of critical manufacturing documentation, including drafting, cross-functional review, and approval of batch records and SOPs.
• Adaptable Technical Skills: Proficient in both high-precision manual laboratory techniques and the operation, maintenance, and troubleshooting of high-throughput automated instrumentation.
• Cross-Functional Collaborator: Adept at bridging gaps between R&D, Quality Assurance, and Engineering teams to ensure seamless internal product transfers and hit aggressive deadlines.
• Workflow Coordination & Mentorship: Experienced in synchronizing cross-functional workflows, overseeing production lines, and designing training schedules to upskill team members on GMP compliance.

Ready for the next step? We look forward to hearing from you. Apply now to discover this exciting opportunity!

Roche Diagnostics International AG in Rotkreuz is one of the world's leading providers of diagnostic system solutions for hospitals, laboratories, and physician offices. With over 2,200 employees, Rotkreuz is one of Roche Diagnostics' main sites, making it the largest manufacturer of fully automated in vitro diagnostic systems in Switzerland with more than 2,700 passionate colleagues from over 65 nationalities. At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare, working together as one of the world's leading research-focused healthcare groups where success is built on innovation, curiosity, and diversity. We believe in the power of diversity and inclusion, striving to identify and create opportunities that enable all people to bring their unique selves to Roche, while offering extensive development and training opportunities, flexible working options, 18 weeks of maternity leave, 10 weeks of gender independent partnership leave, and multiple on-site services such as child-care facilities, medical services, restaurants, cafeterias, and various employee events., A healthier future drives us to innovate. Together, more than 100'000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact. Let's build a healthier future, together. Roche is an Equal Opportunity Employer.