Technical Steward (REQ-10087620)

该职位来源于猎聘 Provide specialist knowledge and expertise regarding aseptic manufacturing technology and validation requirements. Works as aseptic manufacturing technology SME in major aseptic product technical transfer projects. Oversee processes and standards to maintain and improve existing and to implement new innovative manufacturing technologies. Major accountabilities: Technical Transfer Lead

• Design Phase. Actively participate facility and equipment design and selection. Review the URS, design concepts, layouts and technical specifications for facility, equipment and utilities from GMP and aseptic technology perspective. Contribute to contamination control strategy (CCS) development for the new sterile facility.
• Construction and Commissioning. Provide aseptic processing inputs during construction, installation and commissioning activities to ensure alignment with approved design and GMP requirements. Participate in or review FAT/SAT activities for critical equipment and systems.
• Qualification and validation. Work with site validation lead and other SMEs on qualification/validation activities regarding sterile product LCM projects in aspects of facility, HVAC, utilities, equipment, cleaning, sterilization, aseptic manufacturing processes. Product Steward
• Act as the SPOC for the interface with global MS&T network and with technical development organization, for the corresponding global activities, to define and implement new technical standards for existing and new technologies and equipment.
• Owns the knowledge of specific pharmaceutical manufacturing process technologies, locally, including any pilot scale, scale up or down, and Design of Experiments (DoE).
• Participate in the definition and selection of pharmaceutical equipment, through providing input to User Requirements.
• Collaborate with technical development, other sites and global MS&T network to facilitate transfer of technical knowledge.
• Assure that the necessary benchmark is done internally in Novartis, and externally in the scientific and academic environment, in order to stimulate and to extend the knowledge, increasing the know-how of the associates and expanding it to the rest of the organization.
• Be a recognized scientific expert internally and externally by reporting and presenting scientific/technical work at internal/external meetings/conferences and publish in peer reviewed international scientific journals including patents.
• Maintain their work in inspection readiness level.
• Support Product Stewards in creation of Quality Risk Assessments.
• Support creation of SOPs for Process Unit.
• Provide technical expertise to Engineering for design activities in Capex projects around technologies within area of responsibility.
• Provide technical expertise for equipment qualification around technologies within area of responsibility. Validation
• Approve validation reports under their area of responsibility (as needed) e.g. packaging validation.
• Provide technical expertise for validation activities around technologies within area of responsibility. Manufacturing Excellence– for the technology(ies) assigned
• Harmonize and optimize technical processes across the site.
• Benchmark new technologies and equipment relevant for site.
• Designs and controls optimization projects.
• Provide SME expertise to perform process characterization of the related pharmaceutical processes to increase robustness and sustainability.
• Support Product Stewards / Process Experts in trouble shooting / root cause investigation by providing second level of specialist expertise as SME and by harmonising and optimising related technical processes across the units.
• Perform technical feasibility trials related to process improvement and implementation of new manufacturing technologies. Training
• Own the Training Curriculum for own Job Profile and direct reports.
• Provide technical trainings and education programs for Process Experts and Production Operators. Novartis Manufacturing Manual
• Support implementation of Novartis Manufacturing Manual principle 3.
• Provide SME input to Novartis Manufacturing Manual principle 4.
• Represent site in technical stewardship network. Key performance indicators:
• Success rate of qualifications and validations for aseptic product technical transfers.
• Success rate of aseptic product transfer projects.
• Batch release on time/in quality.- aseptic product related.
• Line throughput time. - aseptic product related.
• Deviations – aseptic product related.
• Effective CAPAs-aseptic product related.
• Ppk/CpK – aseptic process capability.
• OoS, OoE – Out of Specification, Out of Expectation –aseptic process related.
• Yield.-aseptic product related.
• Customer Complaints – aseptic process related.
• Recalls – aseptic process related.
• Success rate of internal audits and Health Authorities' inspections.- aseptic product related. 为什么选择诺华：帮助患者及家属不仅需要创新科学，还需要一支包括你我他在内的充满智慧与激情的团队，大家相互协作、支持与激励。共同实现突破，改变患者的生活。一起共创更好的未来，你准备好了吗？ 薪酬与福利：您可以前往诺华官网了解我们帮助您实现个人与职业发展的举措。 无障碍及便利设施： 诺华承诺与残障人士共事并为他们提供合理的便利设施。如果您由于健康状况或残障，在招聘过程的任何环节需要合理便利设施，或者为了履行职位的基本职能，请将您的相关需求告知我们的招聘经理。 加入我们的诺华网络：这不是您心仪的职位？欢迎加入诺华人才社区，与我们保持联系，及时了解合适的职业机会。您也可以关注诺华招聘社交媒体账号。 职位要求： Process Simulation Data Analytics Knowledge Of Capa (Inactive) Risk Management Electronic Components Lean Manufacturing Manufacturing Technologies Chemical Engineering Technology Transfer Manufacturing Processes Process Control Assembly Language (ASM) Manufacturing Production Statistical Analysis Scientific Methods Including Gdp (Inactive) Applied Statistics Six Sigma Root Cause Analysis (RCA) Continual Improvement Process Change Controls General Hse Knowledge

(Inactive) Knowledge Of Gmp (Inactive) Cost Reduction Process and Cleaning Validation (Inactive)