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Job Description Process Expert MAIN ACTIVITIES AND DUTIES: Provide technical support with regards to manufacturing processes, investigations, optimization, yield, improvement projects, cycle time reduction. Support and/or perform investigations and assessments related to the processes. Troubleshooting and problem-solving. Identification/support and management of yield improvement projects, cycle time reduction, and process robustness initiatives. Participation in risk assessment within changes (i.e. pFMEA). Provide technical support with regards to manufacturing processes. Participation in internal and/or external functional/multifunctional teams. Support the preparation of regulatory submissions/meetings. Support regulatory inspections and defend technical decisions to regulatory agencies. Consult technical documentation in the archive. Support small scale trial activities in Lab Scale. BEHAVIOURAL COMPETENCIES AND SKILLS: 3-5 years of experience in multinational or consolidated medium-large pharmaceutical industry. Strong ability to communicate effectively technical material in written and oral English. Statistical knowledge, digital oriented, data analysis mindset, and capacity to drive conclusions based on data. Knowledge of data analysis tools (i.e. MINITAB, SIMCA). Be positive and accountable, results oriented and precise, a good self-manager able to prioritize multiple requests and tasks, and a good team player/leader. Both practical and theoretical knowledge of the purification of plasma proteins. Good presentation skills. EDUCATION: Needed: Master or PhD degree in technical/scientific education, preferably pharmaceutical sciences, chemistry, biochemistry, biotechnology, or pharma-process engineering. Knowledge related to GMP-requirements. Desirable: Six Sigma, DMAIC. ADDITIONAL INFORMATION: Decisions to be taken on a regular basis: for events with low and moderate criticality, the role evaluates the impact of events, defines characterization tests needed, evaluates the impact of changes on the process, collaborates to PFMEA preparation, and defines actions for negative trends of yields and quality attributes. Decisions to be escalated: all topics mentioned above with high criticality. Willingness to travel within Takeda sites. Locations ITA - Rieti
Worker Type Employee
Worker Sub-Type Regular
Time Type Full time
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