Lead Engineer, Msat (Cgt)

Lead Engineer, MSAT (CGT) The actual location of this job is in Singapore. What you will get : ● An agile career and dynamic working culture. ● An inclusive and ethical workplace. ● Compensation programs that recognize high performance. ● Daily company bus from the MRT location near your home to and from the Tuas site. ● Fully paid medical insurance, and option toenrol family members at partially subsidized premiums. Our full list of global benefits can be found here: https://www.lonza.com/careers/benefits. This is an office‑first role. Working together in person supports close, real‑time collaboration and team alignment, enabling us to deliver our best work. You will work primarily in the office, with the flexibility to work remotely for20% of your time (one day per week). What you will do: Technical transfer · Support the timely and successful transfer of customer’s manufacturing process into the Lonza Bioscience Singapore production facility. · Work with other MSAT team members, technical experts from Lonza’s customer companies and work with: · Manufacturing team on training and resource planning for execution of pilot runs/ engineering runs/ study runs. · Supply Chain Management team on reviewing material package for raw materials requirements and bill of materials (BOM)setup. · Project Management team on project deliverables and customer communications. · Quality Assurance (QA) team on regulatory and compliance requirements of the manufacturing process. · Quality Control (QC) team on developing sampling plan. · Validation team on equipment validation for new customer/ product introduction into the facility. · Perform analysis and design of process fit and process-scale up in collaboration with vendors, customer technical experts or Lonza’s Process Development and MSAT teams of other sites. · Design and perform experiments on scaled own process in MSAT lab to support process technology transfer. Follow all applicable lab safety policies. · Author and/ or review of process-related documents i.e. Process overview, APS protocols, development/ investigative protocols and reports. · Develop and define training programs and requirements to facilitate integration of new manufacturing process into Lonza Bioscience Singapore production facility. · Interact with customer technical experts as necessary to progress technology transfer. · Process support · Performs technical review of batch records, process SOPs, deviations, change controls, training documents, protocols, development/ investigative reports, CAPAs. · Support investigations into process issues/ deviations and if required, coordination of the associated troubleshooting activities and/or perform experiments in the MSAT small-scale cell culture process lab. Follow all applicable lab safety policies. · Manage change control implementation for process changes that are driven by process changes/ improvements and coordination of non-GMP and/or non-clinical runs. · Support pre-campaign preparation activities. · Oversight on the production floor to provide support and review of operations. Escalate issues to management appropriately and interface with customer on issue resolution. · Oversight of on-going trainings to ensure alignment between training and process requirements. · Monitor manufacturing run process data and monitor for run-to-run consistency. · Identify and drive implementation of process improvements as required. · Support inspections and audits by customer and regulatory authorities as required. · Support plant start-up and pilot/clinical/commercial run. Perform technical investigations and help author technical reports to support close-out of deviations, trouble-shoot process excursions/issues in operations, and participate in the generation of required change controls. · Able to recognize abnormalities and/or potential event that might affect process, product quality and/or safety &escalate promptly to the appropriate level for attention. · Able to apply problem-solving tools such as 5Whys, 5M, fishbone diagrams to identify root causes. · Uphold data integrity principles in accordance with Lonza policies. Proactively evaluate, identify and improve data integrity process. · Any other duties assigned by your Manager. What we are looking for: · The position requires extensive knowledge in the field of cell and gene therapy and applicable technologies, GMP, ATMP and sterile/ aseptic manufacturing. · Prior hands-on experience in adherent, human cell cultu…