Product Engineering Expert; Manufacturing

Overview

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come.

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Senior Specialist – Tech Transfer & Manufacturing Science (SBX Sequencing) within the DODINL Production Laboratory & QC line organization. Permanent, full‑time role based in Rotkreuz, Switzerland. You will be the key technical anchor for the critical technology transfer of advanced genetic sequencing workflows and the ultimate subject matter expert for technical execution, optimization, and scaling of our proprietary sequencing consumable portfolios in Europe.

• Technology Transfer & Site Alignment:
  Drive the technical transfer of RUO and regulated genetic sequencing workflows (specifically SBX sequencing chemistry) from Roche Santa Clara 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 analysis.
• 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.

Flexible working options, 18 weeks of maternity leave, 10 weeks of gender‑independent partnership leave. Multiple on‑site services such as child‑care facilities, medical services, restaurants, cafeterias, and various employee events.

Roche is an Equal Opportunity Employer.