Manufacturing Process Specialist

2 settimane fa


Milano, Lombardia, Italia Tn Italy A tempo pieno

strongJob Description:/strongbrAs a Manufacturing Process Specialist at Takeda, you will be responsible for providing technical support with regards to manufacturing processes, investigations, optimization, yield, improvement projects, and cycle time reduction. Your expertise will be crucial in supporting and/or performing investigations and assessments related to the processes, as well as troubleshooting and problem-solving. You will also be responsible for identifying and managing yield improvement projects, cycle time reduction, and process robustness initiatives, as well as participating in risk assessments within changes. Additionally, you will provide technical support with regards to manufacturing processes and participate in internal and/or external functional/multifunctional teams. You will also support the preparation of regulatory submissions/meetings, support regulatory inspections, and defend technical decisions to regulatory agencies. Your strong ability to communicate technical material in written and oral English will be essential in this role. You will also be responsible for consulting technical documentation in the archive and supporting small-scale trial activities in Lab Scale. A Master or PhD degree in technical/scientific education, preferably pharmaceutical sciences, chemistry, biochemistry, biotechnology, or pharma-process engineering, is required. Knowledge related to GMP-requirements is also necessary. Desired skills include Six Sigma and DMAIC. You will be responsible for making decisions on a regular basis, including evaluating the impact of events, defining characterization tests needed, evaluating the impact of changes on the process, collaborating on PFMEA preparation, and defining actions for negative trends of yields and quality attributes. Decisions with high criticality will be escalated. Willingness to travel within Takeda sites is also required.brbrstrongKey Responsibilities:/strongbrbrbr* Provide technical support with regards to manufacturing processesbrbr* Support and/or perform investigations and assessments related to the processesbrbr* Troubleshooting and problem-solvingbrbr* Identification and management of yield improvement projects, cycle time reduction, and process robustness initiativesbrbr* Participation in risk assessments within changesbrbr* Provide technical support with regards to manufacturing processesbrbr* Participation in internal and/or external functional/multifunctional teamsbrbr* Support the preparation of regulatory submissions/meetingsbrbr* Support regulatory inspections and defend technical decisions to regulatory agenciesbrbr* Consult technical documentation in the archivebrbr* Support small-scale trial activities in Lab ScalebrbrbrbrstrongRequirements:/strongbrbrbr* Master or PhD degree in technical/scientific education, preferably pharmaceutical sciences, chemistry, biochemistry, biotechnology, or pharma-process engineeringbrbr* Knowledge related to GMP-requirementsbrbr* Desired skills: Six Sigma and DMAICbrbrbrbrstrongWorking Conditions:/strongbrbrbr* Willingness to travel within Takeda sitesbrbrbrbrstrongLocations:/strongbrbrbr* ITA - RietibrbrbrbrstrongWorker Type:/strongbrbrbr* EmployeebrbrbrbrstrongWorker Sub-Type:/strongbrbrbr* RegularbrbrbrbrstrongTime Type:/strongbrbrbr* Full time



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