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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. Join Roche, where every voice matters.

The Position

*Roles & Responsibilities
Technical
Engineering Project Support and Operation Readiness:*

  • Participate in the design and construction of new facilities, including but not limited to process design, equipment selection, URS review, FAT, SAT, IOPQ, APS and other aspects related to the SUT, thereby contributing to project delivery
  • Provide technical and engineering support for MSAT operations, troubleshooting critical issues, optimizing processes, and ensuring alignment with operational goals and compliance requirements
  • Monitor and manage the overall health of products and processes by identifying potential risks, implementing mitigations, and driving continuous improvement to maintain high-quality standards
  • Ensure accurate management and maintenance of direct material specifications and master data, including bill of materials (BOM), to support seamless MSAT operations and supply chain efficiency
  • Collaborate with MSAT leadership to align process engineering strategies with site and global technical roadmaps, ensuring seamless integration and strategic consistency

Technical Expertise & Innovation

  • Lead the design, execution, and oversight of validation activities related to SUT for both new and existing manufacturing processes
  • Evaluate novel components, systems, and technologies for SUT in terms of compatibility, scalability, and cost-effectiveness; author technical assessments and gap analyses accordingly
  • Develop SUT-specific risk management frameworks, such as FMEA and control strategies, to address critical process parameters and ensure product quality
  • Optimize the integration of SUT in aseptic filling lines, including single-use bioreactors, mixers, and downstream systems, to minimize contamination risks and enhance operational flexibility
  • Drive continuous improvement initiatives for SUT processes, with a focus on waste reduction, cycle time optimization, and sustainability

Technical Transfer & Cross-Functional Collaboration

  • Partner with global and site technical teams to transfer SUT-based processes into manufacturing, ensuring seamless scale-up and regulatory readiness
  • Develop, review, and maintain technical documentation while driving knowledge transfer and training initiatives to ensure operational readiness and continuous capability building within cross-functional teams
  • Author and review SUT-related sections in technical transfer documents, including process descriptions, validation summaries, and risk assessments
  • Support regulatory filings (e.g., BLA, MAA) by providing SUT expertise in CMC modules and responding to agency queries
  • Collaborate with Engineering and Validation teams to align SUT equipment qualification plans with site master plans and capital projects

Manufacturing Support & Compliance

  • Provide real-time technical guidance to production teams on SUT operation, troubleshooting, and deviation handling
  • Ensure SUT processes adhere to cGMP, Roche standards, and health authority expectations (NMPA, FDA, EMA)
  • Lead SUT-focused audits and inspections, preparing technical responses and driving corrective actions
  • Lead efforts to optimize processes for aseptic manufacturing, maximizing cost efficiency, and ensuring scalability, robustness, and operational excellence. Drive continuous process improvements by implementing innovative solutions and advanced technologies, enhance equipment performance through effective root cause analysis and troubleshooting

*Leadership*

  • Possesses strong creative leadership aligned with the VACC model, with a proven ability to foster innovation, shape forward-thinking perspectives, and overcome obstacles
  • Support Roche's mission of advancing and boldly championing diversity, equity, and inclusion
  • Establish and sustain strong partnerships with site leaders to ensure alignment around strategic projects and day-to-day activities and to assure mutually successful working relationships
  • Contribute to a culture of continuous improvement and model lean leadership principles
  • Foster a culture of transparency, high performance, empowerment and innovation
  • Represent Roche MSAT in external SUT forums, conferences, and working groups to benchmark against industry best practices
  • Collaborate with SUT vendors to co-develop solutions aligned with Roche's strategic priorities (e.g., closed systems)

*Qualification and Experience
Education/Qualifications*

  • Bachelor's Degree (Pharmaceutical / Biological is preferred) and above

*Job Required Competencies*

  • At least 5 years of experience in SUT (especially DP SUT) and/or material science, with a minimum of 8 years MSAT/Technical or operation experience in the injection pharmaceutical industry, MNC Bio-pharma preferred
  • Prior experience in people management is advantageous
  • Proven expertise in strategic project of Aseptic Filling facility, including design, commissioning & qualification
  • Hands-on experience in new facility startup readiness and operational ramp-up processes
  • Comprehensive knowledge of cGMP and regulations relevant to pharmaceutical industry, especially in biological industry
  • Ability to think strategically, translate high-level strategies into actionable plans, and embrace agile methodologies to foster adaptability and effectiveness
  • Fluent communications skills in English and the ability to effectively communicate, collaborate, and foster positive interactions with team members and stakeholders

Who we are

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.

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