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Die Position
Roche is seeking a highly skilled and top-tier talent—a professional who demands excellence and possesses the competency and experience in both greenfield engineering projects and routine operations. This position will spearhead visual inspection (VI) and local packaging development (LPD) at our state-of-the-art greenfield biopharmaceutical manufacturing facility in Shanghai. This role focuses on driving excellence in visual inspection systems and local packaging operations, ensuring cutting-edge technologies and processes are seamlessly integrated into Roche’s manufacturing model,while maintaining compliance with cGMP/SHE and Roche’s quality standards. In addition, the critical position emphasizes the successful execution of technical transfers and the operational readiness of VI and LPD workflows, ultimately achieving ramp-up and sustained operational excellence.
The MSAT VI Lead/Subject Matter Expert (SME) is a pivotal technical role, designed for exceptional professionals who bring unparalleled expertise and innovative solutions in visual inspection systems and local packaging development, both of which play a critical role in ensuring product quality and compliance in biopharmaceutical manufacturing. The ideal candidate will be a key technical contributor within the team, demonstrating profound knowledge and problem-solving capabilities to address complex challenges while advancing Roche’s global quality and operational standards. Furthermore, the VI SME will actively contribute to risk management, equipment qualification, and seamless technical transfers while fostering collaboration across cross-functional stakeholders to ensure alignment with strategic manufacturing goals. By contributing at a strategic and operational level, the VI SME will drive the successful implementation of advanced inspection technologies, optimized packaging solutions, and regulatory compliance practices. This role demands a strong focus on global and local regulatory alignment, operational excellence, and knowledge sharing to enhance the reliability, efficiency, and scalability of Roche's visual inspection and packaging operations.
Visual inspection (VI) and local packaging development (LPD) Strategy& Execution:
- Serve as a technical authority and strategic advisor for visual inspection systems and local packaging development, ensuring the implementation of state-of-the-art processes that align with cGMP/SHE standards and Roche’s quality policies.
- Provide comprehensive technical oversight of visual inspection and packaging workflows, integrating innovative approaches for automated and manual inspection systems, defect detection accuracy, ensuring uncompromised product quality and compliance with global standards..
- Develop, validate, and standardize packaging processes, including container selection, sealing integrity, and compatibility testing, to deliver robust packaging performance across all product lifecycle stages.
- Serve as an expert in the validation and optimization of LPD and VI systems, enabling seamless production readiness and long-term operational excellence within Roche’s global biopharmaceutical manufacturing framework.
- Champion the introduction of advanced visual inspection technologies and innovative packaging methodologies, such as real-time quality monitoring systems, automated defect classification, and sustainable packaging materials, to enhance accuracy and operational flexibility.
Technology Transfer& Operations:
- Drive the technical transfer of VI systems and packaging processes, ensuring seamless integration of new product introductions (NPI) into commercial production workflows.
- Lead efforts to qualify and optimize visual inspection equipment and packaging systems during new facility start-up, including the validation of inspection machines, container closure integrity testing, and packaging material performance under local regulatory conditions.
- Facilitate continuous improvement in VI and LPD processes by identifying, evaluating, and implementing advanced technologies to enhance defect detection, packaging operations efficiency, and reduce long-term operational risks.
- Define and execute technical transfer strategies aligned with site priorities, global supply chain requirements, and Roche's overarching operational strategy.
Influential Leadership& Global Interaction:
- Demonstrates strong creative leadership skills aligned with the Visionary, Architect, Coach, and Catalyst (VACC) model, with a proven ability to cultivate a forward-thinking outlook and effectively eliminate barriers to progress.
- Collaborate with cross-functional teams (R, QA, Engineering, Supply Chain) to ensure the implementation, optimization, and alignment of visual inspection and local packaging operations.
- Acts as a mentor and coach to less experienced colleagues, providing guidance in mastering complex VI workflows, troubleshooting technical challenges, and developing skills in MSAT operations.
- Facilitate robust interaction and collaboration with global team members, internal stakeholders, and external partners to support alignment on VI and LPD strategies, projects, and key milestones.
Roles& Responsibilities
Technical
Engineering Project and Site Start-Up Support:
- 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 VI, thereby contributing to project delivery.
- Lead the development, implementation, and maintenance of VI systems, ensuring integration into overall facility workflows.
- Collaborate with MSAT leadership to align process engineering strategies with site and global technical roadmaps, ensuring seamless integration and strategic consistency.
- Provide critical expertise, contribute, and deeply involved in the Fit for Future (FFU) program, ensuring successful site start-up of MSAT operations.
Technical Expertise& Innovation
- Lead the design, execution, and optimization of visual inspection systems (automated and manual), ensuring advanced technologies are implemented to achieve accurate defect detection, reliable performance, and regulatory compliance.
- Develop and execute robust local packaging development strategies, including container closure integrity (CCI) testing, mechanical durability evaluation, and transportation validation to ensure packaging meets both global and local market requirements.
- Develop risk management frameworks (e.g., FMEA and control strategies) for VI, addressing critical process parameters to ensure defect detection accuracy and packaging performance consistency.
- Drive technical innovation by implementing digital and automated solutions to enhance equipment performance, reduce batch discrepancies, and improve overall operational flexibility at the site.
- Champion continuous improvement initiatives targeting process robustness, waste reduction, faster cycle times, and optimized equipment performance with a focus on compliance, cost-efficiency, and sustainability.
Technical Transfer& Cross-Functional Collaboration
- Deeply involved in the end-to-end technical transfer from R to commercial manufacturing, ensuring alignment of process parameters, system integration, and facility 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 technical documentation related to visual inspection and packaging processes, including validation reports, risk assessments, system configuration documents, and sections of technical transfer dossiers.
- Act as the primary technical advisor during global and site-level technology transfers, ensuring compliance with cGMP requirements while addressing risks and challenges encountered during scale-up and commercialization.
Manufacturing Support& Compliance
- Provide real-time technical guidance to production teams on issues related to visual inspection accuracy, packaging design, container sealing effectiveness, and regulatory compliance for routine operations.
- Oversee the validation and performance monitoring of visual inspection systems and packaging equipment, ensuring adherence to Roche quality standards and alignment with international regulatory expectations (e.g., FDA, EMA, NMPA).
- Conduct root cause analysis and implement corrective and preventive actions (CAPA) for issues related to visual inspection systems and packaging processes, ensuring continuous improvement in quality and operational efficiency.
- Lead efforts to improve the reliability and automation of VI and LPD systems, reducing operational risks and enhancing process robustness across
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 VI forums, conferences, and working groups to benchmark against industry best practices.
- Collaborate with VI vendors to co-develop solutions aligned with Roche’s strategic priorities (e.g., sustainable packaging innovations).
Qualification and Experience
Education/Qualifications
- Bachelor’s Degree (Pharmaceutical / Biological is preferred) and above
Job Required Competencies
- At least 5 years of experience in visual inspection and/or local packaging development, with a minimum of 8 years MSAT/Technical or operation experience in the injection pharmaceutical industry, MNC Bio-pharma preferred
- Prior experience in formulation and/or aseptic filling is advantageous
- 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.
Wer wir sind
Eine gesündere Zukunft treibt uns zur Innovation an. Mehr als 100.000 Mitarbeiter weltweit arbeiten gemeinsam daran, wissenschaftliche Fortschritte zu erzielen und sicherzustellen, dass jeder Zugang zur Gesundheitsversorgung hat – heute und für zukünftige Generationen. Durch unser Engagement werden über 26 Millionen Menschen mit unseren Medikamenten behandelt und mehr als 30 Milliarden Tests mit unseren Diagnostik-Produkten durchgeführt. Wir ermutigen uns gegenseitig, neue Möglichkeiten zu erkunden, Kreativität zu fördern und hohe Ziele zu setzen, um lebensverändernde Gesundheitslösungen zu liefern.
Gemeinsam können wir eine gesündere Zukunft gestalten.
Roche ist ein Arbeitgeber, der die Chancengleichheit fördert.
