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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 reductionSupport and/or perform investigations and assessments related to the processesTrouble shooting and problem solvingIdentification/support and management of yield improvement projects, cycle time reduction and process robustness initiativesParticipation to risk assessment within changes (i.e. pFMEA)Provide technical support with regards to manufacturing processesParticipation to internal and/or external functional/ multifunctional Team.Support the preparation of regulatory submission / meetingsSupport regulatory inspections and defending technical decisions to regulatory agencies.Consult technical documentation in the archiveSupport small scale trial activities in Lab Scale

BEHAVIOURAL COMPETENCIES AND SKILLS:

3-5 years of experience in multinational or consolidated medium-large pharmaceutical industryStrong ability to communicate effectively technical material in written and oral EnglishStatistical knowledge, digital oriented, data analysis mindset and capacity to drive conclusions based on dataKnowledge of data analysis tools (i.e. MINITAB, SIMCA)Be positive and accountable, be results oriented and precise, be a good self-manager able to prioritize multiple requests and tasks, be a good team player/leader.Both practical and theoretical knowledge of the purification of plasma proteinsGood 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-requirementDesidered: Six Sigma, DMAIC

ADDITIONAL INFORMATION

Decisions to be taken on regular basis: for events with low and moderate criticality the role evaluates the Impact of events, defines characterization tests needed, evaluates impact of changes on the process, collaborates to PFMEA preparation and defines actions for negative trend of yields and quality attributes.Decisions to be escalated: all topics mentioned above with high criticalityWillingness to travel within Takeda sites

Locations

ITA - Rieti

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time